DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The following claim limitations
Sealing member (claim 7)
has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder
Member (Sealing member - claim 7)
coupled with functional language
sealing the cavity region of the cap (Sealing member - claim 7)
without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim(s) 7 has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
sealing layer, layer of material or antiseptic impregnated filed (page 11) or cellophane, PVC (Polyvinylidene Chloride), LDPE (Low-Density Polyethylene), polypropylene, foil, and antiseptic impregnated material (page 4)(Sealing member - claim 7)
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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.
Claim(s) 1, 4-7, 9-10, 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20060030827 A1 to Raulerson et al. (Raulerson) in view of WO 2018172853 A1 to Wilke et al. (Wilke).
Regarding claim 1:
Raulerson discloses:
A device (figures 1-3) for prevention of vascular access port tampering comprising:
a housing unit (160/123/114/152) having a proximal end (104), a distal end (106 or 123), a length therebetween (see the housing extending from 104 to 106), and an interior enclosure (110) configured to receive a catheter line inlet port (192/190);
an opening (154) in the proximal end (104) of the housing unit (160/123/114/152), passing through said housing unit (160/123/114/152) to the interior enclosure (110) and forming a peripheral rim (132) on the proximal end (104) of the housing unit (160/123/114/152) configured to allow passage of tubes attached to the inlet port (192/190); and
a plurality of tabs (134 as shown in figure 4) arranged circumferentially on the peripheral rim (132).
Raulerson fails to disclose:
Wherein the plurality of tabs comprise one or more breakaway features for fracturing at least a portion of the plurality of tabs off of the peripheral rim
Wilke teaches:
A needle cover (figure 2) that includes a tab (24) that can breakaway. The breakaway feature of the tab includes perforations, scores or other cut outs. The tab is breakaway for safety since it indicates if the cover has been used before or not (page 8, ¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Raulerson to make the tabs breakaway with perforations or scores as taught by Wilke in order to indicate to the user if the device has been used before (Wilke, page 8, ¶2). Note, this does not require that the process of using the device of Raulerson breaks the tabs but that they can be broken after use intentionally by withdrawing the port (192/192) or through some other mechanism to prevent future use of the device and precent cross contamination. This is how the tab (24) in Wilke is used, the tab is used for its function and then it is broken off so that it cannot be reused (Wilke, page 8 second paragraph).
Regarding claim 4:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 3 by Raulerson and Wilke:
The device of claim 1, wherein the breakaway features are selected from the group consisting of: notches, indents, holes, perforations, reliefs and scores (see the scores/perforations added to the tab as taught by Wilke and incorporated into Raulerson).
Regarding claim 5:
Raulerson discloses:
The device of claim 1, wherein the housing unit (160/123/114/152) further comprises a cap (118) positioned at the distal end (123) within the interior enclosure (110), wherein the cap (118) is configured to attach to the inlet port (192/190) and block access (¶0016 indicates 118 engages with 190 and preventing it from draining) to the inlet port (192/190).
Regarding claim 6:
Raulerson discloses:
The device of claim 5, wherein the cap (118) comprises a base (see the base B in figure 1 below) and sidewalls (see side walls of A in figure 1 below) extending up proximally from said base (as shown in figure 1 below) forming a cavity region (forms the cavity region between 114 and 118) with a rim (see the rim C in figure 1 below).
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Figure 1 - figure 3 of Raulerson, annotated by the examiner
Regarding claim 7:
Raulerson discloses:
The device of claim 6, further comprising a sealing member (150) connected (connected to C via 114/112 and 118) to the rim (C in figure 1 above) and sealing the cavity region (seals the region between 114 and 118) of the cap (118).
Regarding claim 9:
Raulerson discloses:
The device of claim 5, further comprising one or more antiseptic fluids (168; ¶0029) held within (flows from 168 to region between 118 and 114 via 126 and 119; ¶0028) the cavity region (region between 118 and 114/112) of the circular container cap (118).
Regarding claim 10:
Raulerson discloses:
The device of claim 9, wherein the antiseptic fluids (166) is selected from the group consisting of: isopropyl alcohol (¶0029 indicates 166 can be isopropyl alcohol), isopropanol, chlorhexidine, povidone-iodine, chloroxylenol, hexachlorophene, benzalkonium chloride, and hydrogen peroxide.
Regarding claim 17:
Raulerson discloses:
The device of claim 1, wherein each tab of the plurality of tabs (134) tapers in width from a first end connected to the peripheral rim to a second end positioned in the opening (see figures 5 or 4 where the tabs 134 taper from the peripheral rim to the free second end).
Regarding claim 18:
Raulerson discloses:
A tamper-evident vascular access port cover (figures 1-3), comprising:
a housing (160/123/114/152) having a proximal end (104), a distal end (106), and an interior volume (110), wherein the housing is configured to fully enclose a vascular access port (192/190; in terms of being a vascular access port the reference is silent to the function of the tubing but the housing is capable of this function);
a proximal opening (154) in the housing fluidly connected to the interior volume, the proximal opening defining a peripheral rim (132), wherein tubing attached proximally to the vascular access port extends out through the proximal opening (as shown in figure 1 the tubing 192/194/190 extends out of the port 154);
a plurality tabs (134 as shown in figure 4) arranged on the peripheral rim, wherein the plurality of tabs retain the vascular access port (192/190; the tabs hold and clean the end of the tubing 192/190 as the structure is cleaned by the tabs).
Raulerson fails to disclose:
A plurality of breakaway tabs arranged on the peripheral rim, wherein the plurality of breakaway tabs retain the vascular access port, and wherein removing the vascular access port through the proximal opening fractures at least one breakaway tab of the plurality of breakaway tabs.
Wilke teaches:
A needle cover (figure 2) that includes a tab (24) that can breakaway. The breakaway feature of the tab includes perforations, scores or other cut outs. The tab is breakaway for safety since it indicates if the cover has been used before or not (page 8, ¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Raulerson to make the tabs breakaway with perforations or scores as taught by Wilke in order to indicate to the user if the device has been used before (Wilke, page 8, ¶2). Note, this does not require that the process of using the device of Raulerson breaks the tabs but that they can be broken after use intentionally by withdrawing the port (192/192) or through some other mechanism to prevent future use of the device and precent cross contamination. This is how the tab (24) in Wilke is used, the tab is used for its function and then it is broken off so that it cannot be reused (Wilke, page 8 second paragraph).
Claim(s) 1 and 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20200197686 A1 to Anderson et al. (Anderson) in view of WO 2018172853 A1 to Wilke et al. (Wilke).
Regarding claim 1:
Anderson discloses:
A device (figure 2a-4) for prevention of vascular access port tampering comprising:
a housing unit (10) having a proximal end (see E in figure 2 below), a distal end (see D in figure 2 below), a length therebetween (see the lengths between ends E and D below), and an interior enclosure (20) configured to receive a catheter line inlet port (100/101);
an opening (see opening G in figure 2 below) in the proximal end (see E in figure 2 below) of the housing unit (10), passing through said housing unit (10) to the interior enclosure and forming a peripheral rim (see rim F in figure 2 below) on the proximal end (see E in figure 2 below) of the housing unit (10) configured to allow passage of tubes attached to the inlet port (100/101) (as shown in figure 1a); and
a plurality of tabs (18) arranged circumferentially on the peripheral rim (see rim F in figure 2 below).
Anderson fails to disclose:
Wherein the plurality of tabs comprise one or more breakaway features for fracturing at least a portion of the plurality of tabs off of the peripheral rim.
Wilke teaches:
A needle cover (figure 2) that includes a tab (24) that can breakaway. The breakaway feature of the tab includes perforations, scores or other cut outs. The tab is breakaway for safety since it indicates if the cover has been used before or not (page 8, ¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Anderson to make the tabs breakaway with perforations or scores as taught by Wilke in order to indicate to the user if the device has been used before (Wilke, page 8, ¶2). Note, this does not require that the process of using the device of Raulerson breaks the tabs but that they can be broken after use intentionally by withdrawing the port (192/192) or through some other mechanism to prevent future use of the device and precent cross contamination. This is how the tab (24) in Wilke is used, the tab is used for its function and then it is broken off so that it cannot be reused (Wilke, page 8 second paragraph).
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Figure 2 – figure 4 of Anderson, annotated by the examiner
Regarding claim 2:
Anderson discloses:
The device of claim 1, wherein the plurality of tabs (18) are pointing radially inward and towards the distal end (as shown in figure 2 above the tabs protrude inward and toward the distal end D) of the housing unit (10).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20060030827 A1 to Raulerson et al. (Raulerson) and WO 2018172853 A1 to Wilke et al. (Wilke) as applied to claim 7 above, and further in view of US 20070156118 A1 to Ramsey et al. (Ramsey).
Regarding claim 8:
Raulerson fails to disclose:
The device of claim 7, wherein the sealing member is selected from the group consisting of: cellophane, PVC (Polyvinylidene Chloride), LDPE (Low-Density Polyethylene), polypropylene, foil, and antiseptic impregnated material.
Ramsey teaches:
A device that includes a protective priming cap (see figure 8). The cap further includes an O-ring/sealing member (figure 6) where the O-ring is made of polypropylene (¶0033) to provide a sufficient sealing effect.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Raulerson to make to the sealing member of polypropylene as taught by Ramsey for sufficient sealing effect or performance (Ramsey, ¶0033).
Allowable Subject Matter
Claim 19 is 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.
Response to Arguments
Applicant's arguments filed 7/27/26 have been fully considered but they are not persuasive.
Regarding the 35 USC 103 rejections of claims 1, 5 and 18 with Raulerson:
The applicant has argued the structure identified as tabs in Raulerson are not tabs but are bristles and would not be interpreted as such by one of ordinary skill in the art (see page 7 of the remarks). However, the office is not persuaded by this argument since they include the structure outlined in the claim (arranged circumferentially on the peripheral rim) and since they read on the description of the tabs as indicated in the specification (they have a width and a height (page 13 of the specification)). Further, Merriam-Webster defines a tab as “a short projecting device” which the structure 134 in Raulerson reads on.
Regarding the rejection of claim 5, the applicant has argued that the cap is not located at the distal end of the housing (see page 8 of the remarks). With the amended claim, the rejection of claim 1 and 5 has been amended to indicate the distal end can be interpreted to be 106 or 123 and the cap 118 is located at the distal end 123.
Regarding the 35 USC 103 rejections of claim 2 with Raulerson:
The applicant’s amendments to the claims have addressed the previous claim rejections and for this reason they have been withdrawn.
Regarding the 35 USC 103 rejections of claims 1 and 2 with Anderson and Wilke:
The applicant argues that the Anderson reference does not teach break away tabs (see page 10 of the remarks). The office agrees with the applicant and for this reason the reference was combined with Wilke to read on the claims.
The applicant further argues that the Wilke reference does not teach the plurality of tabs on peripheral rim (see page 10 of the remarks). The office agrees with this argument however this structure is found in Anderson.
The applicant further argues that there is no motivation for the combination of Anderson and Wilke and further that there is no reasonable expectation of success (see page 11 of the remarks). The applicant has argued that the modify Anderson with Wilke would result in the tabs of Anderson not functioning in the manner described in the Anderson reference since they need to remain in place for the cap and the resilient inner body 30 to remain connected together (see page 11 of the remarks). However, the combination with Wilke would not remove this function. The tab in Wilke is fungible or breakable but only after it has performed its function. The scoring or cut outs are put in place and sized to allow the tab in Wilke to operate as intended and then broken after their use to prevent reuse or cross contamination in the future (page 8; the tab hold the opening 22 open and then is broken after use to indicate that it should not be reused). This teaching would work when applied to Anderson or Raulerson since it would allow the tabs to perform their described function but then be broken after use to prevent reuse and cross contamination.
The applicant further argues that the combination of Anderson and Wilke would result in the structure of Anderson unsatisfactory for its intended purpose (see page 12 of the remarks). However, as indicated above, the tab scores or cut outs added to the tabs in Anderson would not render is unable to perform its function but would allow for the tabs to be broken after their use in order to prevent the structure in Anderson from being reused.
The applicant also argues that the hindsight reasoning is used to arrive at the claimed invention and for this reason the combination is improper (see page 13 of the remarks). However, as indicated above, the Wilke reference provides a motivation for this combination in order to prevent reuse of the structures in Anderson or Raulerson and therefore there is no hindsight reasoning.
For these reasons, the rejection with Anderson and Wilke or Raulerson and Wilke have been maintained above.
Regarding the claim objections:
The applicant’s amendments to the claims have addressed the previous claim objections and for this reason they have been withdrawn.
Regarding the 35 USC 112(b) claim rejections:
The applicant’s amendments to the claims have addressed the previous claim rejections and for this reason they have been withdrawn.
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 WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WESLEY G HARRIS/Examiner, Art Unit 3783
