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 Arguments
Applicant's arguments filed have been fully considered but they are not persuasive. Amendments to the current set of claims have changed the scope of the claimed invention, resulting in a modification of the previous prior art rejection.
Applicant discusses on page 6 of the Remarks section, as indicated by the page number at the bottom of each page, the previous 112 rejections and the amendments made to address these issues. The Examiner has withdrawn them as a result.
On pages 6-7, Applicant argues against the previous 103 prior art rejection of independent Claim 1, asserting that previous secondary reference Avula, (US 10603481), does not disclose the claim limitations of “one or more time indicators disposed along a length of the tube, wherein evaporation of the gel is configured to provide a visual indication of a passage of time after activation based on the position of a gel level in relation to the one or more time indicators, the gel level being an end of the gel closest to the open end of the tube”. Here, the Examiner notes that primary reference Lurvey et al., (US 7981381), previous secondary reference, Crawford et al., (“Crawford”, US 2007/0293822), and newly found secondary reference Howlett et al., (“Howlett”, US 2009/0008393), disclose these recited limitations instead, not Avula. The Examiner notes that Avula is relied upon to disclose the positioning of the gel in the tube and the placement of the seal to prevent ambient air contact with said gel, not these other recited limitations in question. The Examiner refers Applicant’s attention to the prior art rejection section below where the other prior art references used disclose these features instead. The Examiner notes that this argument is piecemeal analysis, and is thus unpersuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The same response above applies to Applicant’s remarks regarding independent Claim 7 as well. The rejection of Claim 7 and the dependent claims stand as a result.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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) 1-9, 12, 15-19 & 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lurvey et al., (US 7981381), in view of Avula, (US 10603481), in further view of Crawford et al., (“Crawford”, US 2007/0293822), in further view of Howlett et al., (“Howlett”, US 2009/0008393).
Regarding Claims 1-4, Lurvey discloses an intravenous (IV) disposable time indication device, (See Abstract), comprising: wherein an agent is configured to evaporate at a determined rate of time upon activation, (Access Device 44, and Housing 46, See Figure 6 or 13, See column 11, lines 44-62); and one or more time indicators, (See column 16, lines 46-60), the one or more time indicators disposed along a length of the tube, (Membrane 82 can be formed on surface of Housing 24 or Gland 28, See Figure 14b, See column 15, lines 4-43; Examiner interprets placing this membrane indicator onto surface of Housing 24 or Gland 28 to inherently be present for a certain length of Housing 24/tube. Housing 24 corresponds to Figure 13 as well, which corresponds to Housing 46 of Figure 6 which is corresponding to Figure 2), wherein evaporation of the agent is configured to provide a visual indication of a passage of time after activation, (See column 17, lines 6-25).
Lurvey does not disclose a tube having one open end and containing a volume of gel, a seal configured to prevent contact of the agent with ambient air, or the gel evaporating by exposure to ambient air from an open end of the tube, and the visual indication based on the position of a gel level in relation to the one or more time indicators, the gel level being an end of the gel closest to the open end of the tube.
Avula discloses a tube containing a volume of gel, (See column 5, lines 11-23, lines 36-39), and a seal configured to prevent contact of the agent with ambient air, (See column 5, lines 40-54, See column 6, lines 5-26, Avula). Additional features of this disclosure are included as part of the overall combination and are claim mapped to in the Additional Disclosures section below.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the IV disposable time indication device of Lurvey by incorporating a tube containing a volume of gel as in Avula because it “may be configured to store the antiseptic within the insert”, (See column 5, lines 55-59, Avula), to “improve the exposure of antiseptic to the outer surface of the medical connector while minimizing exposure of the antiseptic inside the medical connector open lumen”, (See Abstract, Avula).
Modified Lurvey does not explicitly disclose the gel evaporating by exposure to ambient air.
Crawford discloses the gel evaporating by exposure to ambient air from an open end of the tube, (See paragraph [0101], [0115], & [0123], See Figure 35, Crawford; the gel is present on an edge facing the outside of the tube). Additional features of this disclosure are included as part of the overall combination and are claim mapped to in the Additional Disclosures section below.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the IV disposable time indication device of modified Lurvey by incorporating the gel evaporating by exposure to ambient air from an open end of the tube as in Crawford to “remind the operator to clean or replace the vascular access device to reduce the risk and occurrence of [catheter related blood stream infection”, (See paragraph [0008] & [0005], Crawford), when using “initiation of the time sensitive status may occur by exposing the status indicator to environmental factors such as…air”, (See paragraph [0101], Crawford), “to achieve a variety of affects in order to tailor…to a particular use within a hospital”, (See paragraph [0111], Crawford).
Modified Lurvey does not disclose the visual indication based on the position of a gel level in relation to the one or more time indicators, the gel level being an end of the gel closest to the open end of the tube.
Howlett discloses the visual indication based on the position of a gel level in relation to the one or more time indicators, the gel level being an end of the gel closest to the open end of the tube, (Cap Assembly 800 with labels on side that correspond to Position of Plunger 810 and Volume of Chamber 820 and thus to level of fluid/antiseptic remaining within chamber, See Figure 26/27, See paragraphs [0105], [0106]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the IV disposable time indication device of modified Lurvey by incorporating the visual indication based on the position of a gel level in relation to the one or more time indicators, the gel level being an end of the gel closest to the open end of the tube as in Howlett so it “indicates to a medical professional how much of fluid…has been administered”, (See paragraph [0106]), as it is provided to “the targeted fluid pathway to reduce or eliminate the existence of microbes therein” or such that it is “primed into a central line to maintain catheter primacy”, (See paragraph [0018], Howlett).
Additional Disclosures Included:
Claim 2: The IV disposable time indication device of claim 1, wherein the seal comprises vacuum sealed packaging containing the tube, (See column 5, lines 40-54, Avula).
Claim 3: The IV disposable time indication device of claim 1, wherein the seal comprises a removable cover disposed on an opening of the tube, (See column 6, lines 5-26, Avula).
Claim 4: The IV disposable time indication device of claim 1, wherein the one or more time indicators comprise one of word descriptions, numbers and symbols, each time indicator indicating a specific use time period, (See column 19, lines 12-32, Avula).
Claims 5 & 6 are directed to an IV set, an apparatus type invention group.
Regarding Claim 5 & 6, modified Lurvey discloses an IV set, comprising: IV tubing, (Connector 42, See Figures 2 & 6, See column 4, lines 40-44, column 7, lines 54-60, column 11, lines 44-62); an IV component coupled to the IV tubing, (Access Device 44, See Figure 6, See column 11, lines 44-62); and the IV disposable time indication device of claim 1, (See rejection of claim 1 above), coupled to one of the IV tubing and the IV component, (Access Device 44 with Indicator, See Figure 6, See column 11, lines 44-62).
Additional Disclosures Included:
Claim 6: The IV set of claim 5, wherein the IV disposable time indication device is disposed on a label and the label is coupled to one of the IV tubing and the IV component, (See column 19, lines 12-32, Avula).
Claims 7-9, 12, 15 & 16 are directed to an IV disposable time indication device, an apparatus type invention group.
Regarding Claims 7-9, 11, 12, 15 & 16, Lurvey discloses an intravenous (IV) disposable time indication device, (See Abstract), comprising: a cap configured to be coupled to an IV component, (Access Device 44, and Housing 46, See Figure 6, See column 11, lines 44-62), the cap comprising: a cavity disposed in an end of the cap, the cavity having a base surface, (See column 11, lines 49-54; gland); a slot disposed in the base surface, (See column 11, lines 52-54; septum), wherein the agent is configured to evaporate at a determined rate of time upon activation, (See column 17, lines 6-25); and one or more time indicators, (See column 16, lines 46-60); the one or more time indicators disposed along a length of the tube, (Membrane 82 can be formed on surface of Housing 24 or Gland 28, See Figure 14b, See column 15, lines 4-43; Examiner interprets placing this membrane indicator onto surface of Housing 24 or Gland 28 to inherently be present for a certain length of Housing 24/tube. Housing 24 corresponds to Figure 13 as well, which corresponds to Housing 46 of Figure 6 which is corresponding to Figure 2), wherein evaporation of the gel is configured to provide a visual indication of a passage of time after activation, (See column 17, lines 6-25).
Lurvey does not disclose a volume of gel in the slot, a seal configured to prevent contact of the agent with ambient air or the gel evaporating by exposure to ambient air, or a cap closer disposed within the cavity, the cap closer comprising a surface disposed on the base surface, the cap closer configured to hold the gel within the slot and to provide an air passageway at a first end of the slot, or the visual indication based on the position of a gel level in relation to the one or more time indicators, the gel level being an end of the gel closest to the open end of the slot.
Avula discloses a tube containing a volume of gel, (See column 5, lines 11-23, 402 lines 36-39), and a seal configured to prevent contact of the agent with ambient air, (See column 5, lines 40-54, See column 6, lines 5-26, Avula), a cap closer disposed within the cavity, the cap closer comprising a surface disposed on the base surface, the cap closer configured to hold the gel within the slot and to provide an air passageway at a first end of the slot, (Body 408 within Cap body 420 retaining and on top of Gel Antiseptic Reservoir 412 on interior surface of Cap body 420, opening (air passageway) is provided within open end 444 of Luer, See Figures 4A/4B, See column 8, lines 24-55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the IV disposable time indication device of Lurvey by incorporating a tube containing a volume of gel, a seal configured to prevent contact of the agent with ambient air, and a cap closer disposed within the cavity, the cap closer comprising a surface disposed on the base surface, the cap closer configured to hold the gel within the slot and to provide an air passageway at a first end of the slots in Avula because it “may be configured to store the antiseptic within the insert”, (See column 5, lines 55-59, Avula), to “improve the exposure of antiseptic to the outer surface of the medical connector while minimizing exposure of the antiseptic inside the medical connector open lumen”, (See Abstract, Avula).
Crawford discloses the gel evaporating by exposure to ambient air, (See paragraph [0101], [0115], & [0123], Crawford). Additional features of this disclosure are included as part of the overall combination and are claim mapped to in the Additional Disclosures section below.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the IV disposable time indication device of modified Lurvey by incorporating the gel evaporating by exposure to ambient air as in Crawford to “remind the operator to clean or replace the vascular access device to reduce the risk and occurrence of [catheter related blood stream infection”, (See paragraph [0008] & [0005], Crawford), when using “initiation of the time sensitive status may occur by exposing the status indicator to environmental factors such as…air”, (See paragraph [0101], Crawford), “to achieve a variety of affects in order to tailor…to a particular use within a hospital”, (See paragraph [0111], Crawford).
Modified Lurvey does not disclose the visual indication based on the position of a gel level in relation to the one or more time indicators, the gel level being an end of the gel closest to the open end of the tube.
Howlett discloses the visual indication based on the position of a gel level in relation to the one or more time indicators, the gel level being an end of the gel closest to the open end of the slot, (Cap Assembly 800 with labels on side that correspond to Position of Plunger 810 and Volume of Chamber 820 and thus to level of fluid/antiseptic remaining within chamber, See Figure 26/27, See paragraphs [0105], [0106]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the IV disposable time indication device of modified Lurvey by incorporating the visual indication based on the position of a gel level in relation to the one or more time indicators, the gel level being an end of the gel closest to the open end of the slot as in Howlett so it “indicates to a medical professional how much of fluid…has been administered”, (See paragraph [0106]), as it is provided to “the targeted fluid pathway to reduce or eliminate the existence of microbes therein” or such that it is “primed into a central line to maintain catheter primacy”, (See paragraph [0018], Howlett).
Additional Disclosures Included:
Claim 8: The IV disposable time indication device of claim 7, wherein the cap further comprises a disinfecting substance disposed on an inner surface of the cap and configured to sterilize a surface of the IV component when the cap is coupled to the IV component, (See column 5, lines 11-23, lines 36-39).
Claim 9: The IV disposable time indication device of claim 7, wherein the cap comprises internal threads configured to mate with external threads of the IV component, (Cap Body 920 has Ridges 918 coupled with Luer Connector 932 and First End 936, See Figures 9A-C, See column 10, lines 28-58, Avula).
Claim 12: The IV disposable time indication device of claim 7, further comprising: a cap closer configured to fit within the cavity, the cap closer comprising a surface configured to contact the base surface and to hold the gel within the slot, (Surface 242, See Figure 36, See paragraph [0125], Crawford).
Claim 15: The IV disposable time indication device of claim 7, wherein the seal comprises vacuum sealed packaging containing the cap, (See column 5, lines 40-54, Avula).
Claim 16: The IV disposable time indication device of claim 7, wherein the one or more time indicators comprise one of word descriptions, numbers and symbols, each time indicator indicating a specific use time period, (See column 19, lines 12-32, Avula).
Regarding Claims 17 & 18, modified Lurvey discloses an IV set, comprising: IV tubing, (Connector 42, See Figures 2 & 6, See column 4, lines 40-44, column 7, lines 54-60, column 11, lines 44-62, Lurvey); an IV component coupled to the IV tubing, (Access Device 44, See Figure 6, See column 11, lines 44-62, Lurvey); and the IV disposable time indication device of claim 1, (See rejection of claim 1 above), coupled to one of the IV tubing and the IV component, (Access Device 44 with Indicator, See Figure 6, See column 11, lines 44-62, Lurvey).
Additional Disclosures Included:
Claim 18: The IV set of claim 17, wherein the IV component is a threaded needleless connector, (Luer Connector 932 and First End 936, See Figures 9A-C, See column 10, lines 28-58, Avula), and wherein the cap comprises threads and a disinfecting substance disposed on an inner surface of the cap, (Cap Body 920 has Ridges 918, See Figures 9A-C, See column 10, lines 28-58, Avula; and See column 5, lines 11-23, lines 36-39), the cap configured to sterilize a connection surface of the needleless connector when the cap is screwed onto the needleless connector, (See column 10, lines 41-67, and See column 4, lines 45-67, column 5, lines 1-39, Avula).
Claim 19 is directed to a method of operating an IV disposable time indication device, a method type invention group.
Regarding Claim 19, modified Lurvey discloses a method of operating the intravenous (IV) disposable time indication device of claim 1, (See Abstract, Lurvey), the method comprising: placing an IV component into use for an IV infusion process, (Access Device 44, and Housing 46, See Figure 6, See column 11, lines 44-62, Lurvey), removing the seal from the IV disposable time indication device coupled to the IV component, (See column 5, lines 40-54, See column 6, lines 5-26, Avula); exposing the gel within the IV disposable time indication device to ambient air, (See paragraph [0101], [0115], & [0123], Crawford; and Access Device 44, and Housing 46, See Figure 6, See column 11, lines 44-62, Lurvey); visually identifying a level of the gel relative to the one or more time indicator markings disposed adjacent to the gel, (See column 17, lines 6-25 and See column 19, lines 12-32, Avula) and determining a remaining use life of the IV component based on the time indicator marking closest to the identified level of gel, (See column 17, lines 6-25, Avula; See paragraphs [0105], [0106], Howlett).
Claim 21 is directed to a method of operating an IV disposable time indication device, a method type invention group.
Regarding Claim 21, modified Lurvey discloses a method of operating the intravenous (IV) disposable time indication device of claim 7, (See Abstract, Lurvey), the method comprising: placing an IV component into use for an IV infusion process, (Access Device 44, and Housing 46, See Figure 6, See column 11, lines 44-62, Lurvey), removing the seal from the IV disposable time indication device coupled to the IV component, (See column 5, lines 40-54, See column 6, lines 5-26, Avula); exposing the gel within the IV disposable time indication device to ambient air, (See paragraph [0101], [0115], & [0123], Crawford; and Access Device 44, and Housing 46, See Figure 6, See column 11, lines 44-62, Lurvey); visually identifying a level of the gel relative to the one or more time indicator markings disposed adjacent to the gel, (See column 17, lines 6-25 and See column 19, lines 12-32, Avula) and determining a remaining use life of the IV component based on the time indicator marking closest to the identified level of gel, (See column 17, lines 6-25, Avula; See paragraphs [0105], [0106], Howlett).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lurvey et al., (US 7981381), in view of Avula, (US 10603481),, in further view of Crawford et al., (“Crawford”, US 2007/0293822), in further view of Howlett et al., (“Howlett”, US 2009/0008393), in further view of Purdy et al., (“Purdy”, US 5,535,771).
Claim 10 is directed to an IV disposable time indication device, an apparatus type invention group.
Regarding Claim 10, modified Lurvey discloses the IV disposable time indication device of claim 7, but does not disclose wherein the cap comprises: a tether coupled to the cap; and an attachment member coupled to the tether, wherein the attachment member is configured to be coupled to the IV component.
Purdy discloses wherein the cap comprises: a tether coupled to the cap; and an attachment member coupled to the tether, wherein the attachment member is configured to be coupled to the IV component, (Tether 83 and Plug 80 and Fitting 60 engaging with Adapter 10, See Figure 2, See column 6, lines 39-49, Purdy).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of modified Lurvey by incorporating wherein the cap comprises: a tether coupled to the cap; and an attachment member coupled to the tether, wherein the attachment member is configured to be coupled to the IV component as in Purdy for “closing the…luer fitting…and the…luer”, (See column 6, lines 39-41, Purdy), in “a valved adapter for medical access devices…plus the advantage of being easily closed by a protective cap”, (See column 2, lines 19-23, Purdy).
Claim(s) 13 & 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lurvey et al., (US 7981381), in view of Avula, (US 10603481), in further view of Crawford et al., (“Crawford”, US 2007/0293822), in further view of Howlett et al., (“Howlett”, US 2009/0008393), in further view of McKinnon et al., (“McKinnon”, US 2008/0132877).
Claim 13 & 14 are directed to an IV disposable time indication device, an apparatus type invention group.
Regarding Claims 13 & 14, modified Lurvey discloses the IV disposable time indication device of claim 7, but does not disclose wherein the cap closer comprises a vent portion configured to provide an air passageway between the gel in the slot and ambient air.
McKinnon discloses wherein the cap closer comprises a vent portion configured to provide an air passageway between the gel in the slot and ambient air, (See paragraphs [0010]-[0012], McKinnon).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of modified Lurvey by incorporating wherein the cap closer comprises a vent portion configured to provide an air passageway between the gel in the slot and ambient air as in McKinnon in order to “reduce complications, such as the risk and occurrence of CRBSIs, by providing septum venting structures and methods that maximize proper septum functionality”, (See paragraph [0009], McKinnon).
Additional Disclosures Included:
Claim 14: The IV disposable time indication device of claim 13, wherein the seal comprises a removable cover disposed on the cap and covering the vent portion, (See column 6, lines 44-67, column 7, lines 1-24, Avula; removable cover covers cap and all its contents).
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 JONATHAN M PEO whose telephone number is (571)272-9891. The examiner can normally be reached M-F, 9AM-5PM.
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/JONATHAN M PEO/Primary Examiner, Art Unit 1779