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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “AA” in Fig. 2; “A4” in Fig. 10.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 11 is/are objected to because of the following informalities:
Claim 11 should read “the flow insert [[g]]” [lines 10-11].
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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(s) 10 is/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 10 recites the limitation “the second end” [line 2], which lacks antecedent basis and is further indefinite, as neither claims 1 or 10 explicitly define a “second end” and it is also unclear whether the recited second end of claim 10 may be meant to refer to either of the previously defined “second end portion” of the proximal housing in claim 1 [lines 2-3] or “second end portion” of the distal housing in claim 1 [line 4], or refer to a second end of the resilient valve itself [relative to the previously defined first end of the resilient valve]. For examination purposes, the Examiner has interpreted the indefinite limitation to read “[[the]] a second end of the resilient valve”.
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) 11-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mijers (US-20160129181-A1).
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 ¶00490; see also Annotated Fig. 1];
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, and an aperture that extends through the resilient valve, from the first end to a second end of the resilient valve [elastomeric diaphragm 24 (Mijers Figs. 2, 4-6); see also Annotated Figs. 1 and 2];
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 (Mijers ¶0046)] such that in a first orientation of the resilient valve, the inner portion is spaced apart from the flow insert g by a first distance to permit a fluid to move between the first and second segments of the fluid passage [see Mijers Fig. 5, wherein as depicted, the elastomeric diaphragm 24 (resilient valve) is spaced apart from the support structure 45 (flow insert) by a first (non-zero) distance and a flow path between the elastomeric diaphragm 24 and support structure 45 is defined], 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 between the first and second segments of the fluid passage [see Mijers Fig. 4, wherein as depicted, the elastomeric diaphragm 24 is spaced apart from the support structure 45 by a second distance (zero), such that no flow path between the elastomeric diaphragm 24 and the support structure 45 is defined].
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Annotated Fig. 1. The Examiner has annotated Fig. 4 of Mijers to indicate the first segment and second segment of the flow insert; wherein as similarly depicted in Fig. 3 of Mijers the outer surface portion as annotated above may be considered to define a first segment of the fluid passage defined by the flow insert [at least valve seat 46] and the inner surface portion as annotated above may be considered to define a second segment of the fluid passage defined by the flow insert [see fluid path as indicated in Mijers Fig. 5]. The Examiner has also annotated Fig. 4 of Mijers to indicate the first end of elastomeric diaphragm 24 [resilient valve] engaged against the outer surface of the flow insert, wherein the Examiner notes that the passages 38 through the elastomeric diaphragm 24 may be considered to be positioned on the first end of elastomeric diaphragm 24 and define an inner portion that is aligned with the second segment of the fluid passage of the flow insert [as the flow path indicated in Fig. 5 defines an alignment between the identified second segment and the inner portion of the elastomeric diaphragm 24] and that the surface of blocking disk 37 on the first end of elastomeric diaphragm 24 may define an outer portion that is aligned with the first segment of the fluid passage [as the flow path indicated in Fig. 5 is defined by the alignment between the surface of blocking disk 37 on the first end of elastomeric diaphragm 24 and the first segment].
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Annotated Fig. 2. The Examiner has annotated Fig. 4 of Mijers to indicate the second end of the resilient valve, wherein as depicted in at least Figs. 2 and 4-5, there exists an aperture [see encircled portion] that extends from the outer portion of the first end of the resilient valve, through passages 38, and towards the identified second end of the resilient valve.
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 Figs. 3-5, the second segment of the fluid passage (see Annotated Fig. 1) may define an axis therethrough (axis 30 in Figs. 4-5); and wherein the first segment of the fluid passage (valve seat 46) is considered to extend 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. 3].
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Annotated Fig. 3. 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 Annotated Fig. 3; wherein the Examiner notes that the portion of the first segment of the fluid passage that extends as indicated by the arrow indicating a radial spiral direction is considered to define a channel that extends into the outer surface of the flow insert (a flow region between valve seat 46 and valve seat 44 (Mijers ¶0051))].
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 Figs. 3-5, the flow region between valve seats 44 and 46 (channel) is considered to extend along a plane that is transverse to axis 30 (Fig. 4)].
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 [wherein a groove defined by a surface of the flow region between valve seat 46 and valve seat 44 (Mijers ¶0051) may be considered to be between a distal-most portion of the first segment of the fluid passage and a proximal-most portion of the second segment of the fluid passage].
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 [see Annotated Fig. 4].
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Annotated Fig. 4. The Examiner has annotated Fig. 5 of Mijers to indicate the second end of elastomeric diaphragm 24 [resilient valve]; wherein the Examiner has further indicated a convex surface formed along the first end of the elastomeric diaphragm 24, which includes at least a portion of passage 38 [inner surface of diaphragm 24]; and wherein the Examiner has further indicated a concave surface formed along the identified second end of the elastomeric diaphragm 24, which includes as least a portion of passage 38.
Regarding claim 18, Mijers teaches
The flow restriction device of Claim 11, wherein the aperture extends through the outer portion of the resilient valve [see Annotated Fig. 2].
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 aperture as defined in Annotated Fig. 2 is considered to be aligned with the first segment, as the flow path defined in Fig. 5 may pass through the first segment and then through the aperture, which is considered to define an alignment].
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].
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Annotated Fig. 5. The Examiner has annotated Fig. 4 of Mijers to indicate the second end of the resilient valve, wherein as depicted in at least Figs. 2 and 4-5, the outer peripheral region 32 [alignment ridge] having a thickness is considered to read on extending from the first end in a direction away from the second end.
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) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mijers (US-20160129181-A1) in view of Brignola (US-4244378-A, cited by Applicant in IDS dated 11 September 2023, not presently included in Notice of References Cited).
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. 6];
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. 6];
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 ¶00490; 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];
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 (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 between the first and second segments of the fluid passage [see Mijers Fig. 5, wherein as depicted, the elastomeric diaphragm 24 (resilient valve) is spaced apart from the support structure 45 (flow insert) by a first (non-zero) distance and a flow path between the elastomeric diaphragm 24 and support structure 45 is defined], 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 between the first and second segments of the fluid passage [see Mijers Fig. 4, wherein as depicted, the elastomeric diaphragm 24 is spaced apart from the support structure 45 by a second distance (zero), such that no flow path between the elastomeric diaphragm 24 and the support structure 45 is defined].
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Annotated Fig. 6. 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 Figs. 3-5, the second segment of the fluid passage (see Annotated Fig. 1) may define an axis therethrough (axis 30 in Figs. 4-5); and wherein the first segment of the fluid passage (valve seat 46) is considered to extend 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. 3].
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 Annotated Fig. 3; wherein the Examiner notes that the portion of the first segment of the fluid passage that extends as indicated by the arrow indicating a radial spiral direction is considered to define a channel that extends into the outer surface of the flow insert (a flow region between valve seat 46 and valve seat 44 (Mijers ¶0051))].
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 Figs. 3-5, the flow region between valve seats 44 and 46 (channel) is considered to extend along a plane that is transverse to axis 30 (Fig. 4)].
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 [wherein a groove defined by a surface of the flow region between valve seat 46 and valve seat 44 (Mijers ¶0051) may be considered to be between a distal-most portion of the first segment of the fluid passage and a proximal-most portion of the second segment of the fluid passage].
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 [see Annotated Fig. 4].
Regarding claim 8, Mijers in view of Brignola teaches
The flow restriction device of Claim 1, wherein the resilient valve comprises an aperture that extends through the outer portion, from the first end through a second end, of the resilient valve [see Annotated Fig. 2].
Regarding claim 9, Mijers in view of Brignola teaches
The flow restriction device of Claim 8, wherein the distal housing comprises a flow channel that extends along the second end portion, the flow channel having a proximal end that intersects the passage of the distal housing, and a distal end, and wherein the distal end of the flow channel is aligned with the aperture of the resilient valve [see Annotated Fig. 7].
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Annotated Fig. 7. The Examiner has annotated Fig. 5 of Mijers to indicate the flow channel, which is considered to be defined by a portion of the second end portion of the distal housing [see Annotated Fig. 6]; and wherein the flow channel is considered to extend from a proximal end that intersects the passage of the distal housing [that extends along axis 30; see flow path defined in Fig. 5] and a distal end that is aligned with the aperture of the resilient valve, as the distal end of the flow channel as indicated is considered to define a portion of the flow path that travels through the aperture [see Annotated Fig. 2].
Regarding claim 10, Mijers in view of Brignola teaches
The flow restriction device of Claim 1, 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].
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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