DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed October 30th 2025 has been entered. Claims 1-20 are pending in the application. Applicant’s amendments have not overcome each and every objection previously set forth in the Non-Final Office Action mailed July 31st 2025.
Claim Objections
Claims 1-11 are objected to because of the following informalities: all recitations of “the indicator portion” should be corrected to “the circular indicator portion” for claim language consistency. Appropriate correction is required.
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 11 is 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.
Regarding claim 11, the recitation of “an integrally formed indicator portion” renders the claim unclear. It is unclear if the integrally formed indicator portion is intended to be another indicator portion or if the integrally formed indicator portion is intended to reference the indicator portion of claim 1 and further limit it to be integrally formed. Based on the drawings and specification, the Examiner is interpreting the integrally formed indicator portion to be in reference to the indicator portion of claim 1 but further limited to be integrally formed with the IV component. The Examiner suggest rewriting the claim to read “…the circular indicator portion is configured to change color after the determined amount of time, wherein the circular indicator portion is integrally formed with the IV component”, removing “an integrally formed indicator portion” while retaining the newly amended limitation which appropriately address the subject matter.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-8 and 11-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Crawford (US 20070293822 A1).
Regarding claim 1, Crawford disclose an intravenous (IV) set (see [0143] & Fig. 44), comprising: an IV component (IV access device 10, [0060] & Fig. 1); and a duration monitor device coupled to the IV component (status indicator 138, 156/158, disk 160, and strip 142, are all examples of a duration monitor that may be coupled to device 10, see [0080]-[0097] & Fig. 13-20), the duration monitor device comprising a circular indicator portion configured to change color after a determined amount of time upon activation of the indicator portion (embodiments of status indicators 156/158 and 160 include portions that change color after a period of time upon activation, [0080]-[0097]; indicators 156/158 seen changing color around a circular portion of device 10 and indicator 160 disclosed as being a disk, see Figs. 16-19 & [0096]), wherein the duration monitor is configured to provide an indication of passage of a use-life time period of one of the IV set and the IV component (see abstract and [0010]).
The Examiner notes that Crawford discloses that “It will be readily understood that the components of the present invention, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations”, [0059].
Regarding claim 2, Crawford discloses all the limitations of claim 1. Crawford further discloses the IV set wherein the indicator portion comprises one or more chemicals configured to activate when exposed to humidity in ambient air (the device 10 may comprise a substrate, “…a status indicator may communicate an elapsed period of time to an operator through a transparency or refractive index change of a material forming the body 12 of the device 10. The change of transparency of the substrate of the material may be initiated by oxidation, moisture absorption, or polymer crystallization… the substrate is a material that absorbs moisture. When the moisture content of the substrate reaches a specified amount, the substrate swells, causing a change in optical properties of the material.”, [0097] & Figs. 18-20; the substrate is being interpreted as the indicator portion which is formed of a material, the material inherently comprising a chemical compound allowing for the absorption of moisture causing the substrate to swell; the exposure to moisture is being interpreted as exposure to humidity in ambient air).
Regarding claim 3, Crawford discloses all the limitations of claim 2. Crawford further discloses the IV set wherein the indicator portion is exposed to the humidity upon one of opening sealed packaging containing the IV set and removing the IV set from sealed packaging (“a device 10 package is resistant to the environmental factors that initiate a time sequence of any of the status indicators discussed herein. Depending on the particular status indicator, the package includes a barrier to light, oxygen and/or other gasses, and moisture, as appropriate. The package may also include a mechanism to initiate the time sequence of the particular status indicator upon removal from the package”, [0099]).
Regarding claim 4, Crawford discloses all the limitations of claim 2. Crawford further discloses the IV set, the duration monitor device further comprising a cover disposed on the indicator portion, wherein the indicator portion is exposed to the humidity upon removal of the cover from the indicator portion (“a dust cover protecting certain structures on the vascular access device 10 may be removed after the device 10 is removed from its sterile packaging or after the vascular access device 10 is attached to another device. The dust cover may be removed by pulling the dust cover from a surface of the body 12 of the vascular access device 10 or by twisting and pulling the dust cover from the device 10. The device 10 may also be removed from the package, and a portion of the package may cause a status indicator to begin the time sequence that places it in service”, [0070]; the status indicator would be exposed to humidity upon removal of the dust cover from device 10).
Regarding claim 5, Crawford discloses all the limitations of claim 1. Crawford further discloses the IV set wherein the indicator portion comprises one or more chemicals configured to activate when exposed to a light source (photochromic material 156/158 including chemical compounds configured to activate when exposed to light, [0089]-[0090] & Fig. 16-17). Additionally, the embodiment including strip 142 comprises a color changing substrate 148 that changes color when exposed to light (see [0082]-[0083] & Fig. 14-15).
Regarding claim 6, Crawford discloses all the limitations of claim 5. Crawford further discloses the IV set wherein the indicator portion is configured to be exposed to the light source upon removing the IV set from light blocking packaging (“a device 10 package is resistant to the environmental factors that initiate a time sequence of any of the status indicators discussed herein. Depending on the particular status indicator, the package includes a barrier to light, oxygen and/or other gasses, and moisture, as appropriate. The package may also include a mechanism to initiate the time sequence of the particular status indicator upon removal from the package”, [0099]).
Regarding claim 7, Crawford discloses all the limitations of claim 5. Crawford further discloses the IV set, wherein the duration monitor device further comprising a cover disposed on the indicator portion, wherein the indicator portion is configured to be exposed to the light source upon removal of the cover from the indicator portion (“a dust cover protecting certain structures on the vascular access device 10 may be removed after the device 10 is removed from its sterile packaging or after the vascular access device 10 is attached to another device. The dust cover may be removed by pulling the dust cover from a surface of the body 12 of the vascular access device 10 or by twisting and pulling the dust cover from the device 10. The device 10 may also be removed from the package, and a portion of the package may cause a status indicator to begin the time sequence that places it in service”, [0070]; the status indicator would be exposed to light upon removal of the dust cover from device 10).
Regarding claim 8, Crawford discloses all the limitations of claim 5. Crawford further discloses the IV set wherein the indicator portion is configured to be activated only by exposure to a specific wavelength of light (photochromic material 158 may be modified to provide a material that only changes color when in the presence of ultraviolet light, [0091] & Fig. 17).
Regarding claim 11, Crawford discloses all the limitations of claim 1. Crawford further discloses the IV set wherein the duration monitor device is a portion of material integrally formed with the IV component (status indicator 160 being a color changing disk which can be integrally formed with device 10, [0096] and [0142] & FIG. 18-19), and wherein upon exposure of the IV component to an activation source, the remaining portion of the IV component is configured to maintain its color over time and an integrally formed indicator portion is configured to change color after the determined amount of time, wherein the indicator portion is integrally formed with the IV component (“the disk 160 has changed from a light color to a dark color consistent with the principles discussed herein.”, [0096] & Fig. 18-19; “Photochromic materials may be used to, for example, indicate a passage of time during which a photochromic material has been exposed to light or the lack thereof”, [0089]; upon exposure to light, disk 160 changes color while the remaining portion of device 10 is seen maintaining its color, see Fig. 18-19).
Regarding claim 12, Crawford discloses all the limitations of claim 1. Crawford further discloses the IV set wherein the duration monitor device comprises a first material integrally formed with a second material of a body of the IV component by co-injection (photochromic dye added at the time of injection molding of the body 12, which is made of a separate polymer, [0087] and [0094] & Fig. 17), wherein the body of the IV component is configured to change color after the determined amount of time upon the activation (body 12 configured to change color to a dark color 158 after at least 24 hours of device 10 service, [0087]-[0088] & Figs. 16-17).
However, Applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
The limitation of “a first material integrally formed with a second material of a body of the IV component by one of co-injection and co-molding” is considered to be a product-by-process limitation. A product-by-process limitation adds no patentable distinction to the claim, and is unpatentable if the claimed product is the same as a product of the prior art.
Regarding claim 13, Crawford discloses all the limitations of claim 1. Crawford further discloses the IV set wherein the duration monitor device comprises an indicator material disposed on a base material of a body of the IV component by coating (“the photochromic dye may also be applied as a coating to the body 12 or septum 16. The dye may be mixed with a solvent and the mixture sprayed, poured, atomized, printed, or dipped onto the appropriate surface. The solvent will evaporate leaving the dye on the surface.”, [0095]), wherein the body of the IV component is configured to change color after the determined amount of time upon the activation (body 12 configured to change color to a dark color 158 after at least 24 hours of device 10 service, [0087]-[0088] & Figs. 16-17).
However, Applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
The limitation of “an indicator material disposed on a base material of a body of the IV component by one of coating and over-molding” is considered to be a product-by-process limitation. A product-by-process limitation adds no patentable distinction to the claim, and is unpatentable if the claimed product is the same as a product of the prior art.
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) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crawford (US 20070293822 A1).
Regarding claims 9-10, Crawford discloses all the limitations of claim 1. The embodiment of status indicator 160 of Crawford discloses the status indicator 160 attached to the exterior surface of device 10 (see [0096] & Fig. 18-19) but fails to explicitly disclose the duration monitor device comprising a backing portion and the indicator portion is disposed on the backing portion, wherein the indicator portion is disposed on a first side of the backing portion, and wherein an adhesive coating is disposed on a second side of the backing portion, the adhesive coating configured to affix the duration monitor device to a surface of the IV component.
However, the embodiment of status indicator 138 and strip 142 of Crawford teaches the duration monitor device (status indicator 138 and strip 142 coupled to device 10, see [0080]-[0086] & Fig. 13-15) comprises a backing portion and the indicator portion is disposed on the backing portion (“a light… sensitive strip [142] is mounted on an adhesive backing and applied to any time sensitive device 10”, [0083]-[0085]), wherein the indicator portion is disposed on a first side of the backing portion (light sensitive strip 148 is being interpreted as disposed on a first side, [0085] & Fig. 15), and wherein an adhesive coating is disposed on a second side of the backing portion (the side of the adhesive backing containing the adhesive is being interpreted as the second side, [0085]), the adhesive coating configured to affix the duration monitor device to a surface of the IV component (the adhesive backing used to apply the light sensitive strip to device 10, [0085] & Fig. 13).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the embodiment of disk 160 of Crawford with the embodiment of indicator 138 and strip 142 of Crawford to include a backing portion and the indicator portion disposed on the backing portion, wherein the indicator portion is disposed on a first side of the backing portion, and wherein an adhesive coating is disposed on a second side of the backing portion, the adhesive coating configured to affix the duration monitor device to a surface of the IV component, since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009. The prior art also indicates “It will be readily understood that the components of the present invention, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations”, [0059].
As modified, disk 160, disclosed as attached to device 10, would include an adhesive backing which would facilitate the disclosed attachment. Disk 160 would be disposed on a first side of the adhesive backing and an adhesive would be disposed on a second side configured to attach disk 160 to device 10.
Alternatively, with regard to claim 9, the duration monitor device coupled to the IV component can be interpreted as status indicator 138 and strip 142 coupled to device 10 (see [0080]-[0097] & Fig. 13-20), the duration monitor device comprising an indicator portion configured to change color after a determined amount of time upon activation of the indicator portion (status indicators 138 and strip 142 include portions that change color after a period of time upon activation, [0080]-[0086]), wherein the duration monitor is configured to provide an indication of passage of a use-life time period of one of the IV set and the IV component (see abstract and [0010] and [0085]), wherein the duration monitor device comprises a backing portion and the indicator portion disposed on the backing portion (“a light… sensitive strip [142] is mounted on an adhesive backing and applied to any time sensitive device 10”, [0083]-[0085]).
Crawford further discloses “Multiple labels, disks, and/or bands of varying lengths may be used in combination on a single device 10 to indicate the passage of multiple periods of time” ([0086]) but does not explicitly disclose status indicator 138 and strip 142 as circular.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the length of the indicator of Crawford to extend further around the circular body of device 10 since it has been held “that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929). See MPEP 2144.05.11.A. In the instant case, the status indicator would not operate differently if it was long enough to be wrapped around device 10 and therefore be circular. One of ordinary skill in the art would be motivated to make such a modification to provide greater visibility of the status indicator.
Further, the embodiment of disk 160 of Crawford teaches the status indicator being in the shape of a disk ([0096] & Fig. 18-19). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the embodiment of status indicator 138 and strip 142 of Crawford with the embodiment of disk 160 of Crawford to include the status indicator being circular since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009. The prior art also indicates “It will be readily understood that the components of the present invention, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations”, [0059].
Also see MPEP 2144.04.IV.B. for discussion on device configuration being a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed apparatus was significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). The status indicator being circular is simply a matter of choice. Applicant places no criticality on the shape of the duration monitor, stating “…a duration monitor device may have any suitable form or format. For example, instead of the circular form shown in duration monitor device 200, the duration monitor device may be a linear strip patch, an oval patch, a square patch or any other geometric shaped patch where the indicator portion changes color at the rated use-life time.” (see [0036] of the present disclosure).
Regarding claim 10, Crawford, as modified, discloses all the limitations of claim 9. Crawford further discloses the IV set wherein the indicator portion is disposed on a first side of the backing portion (light sensitive strip 148 is being interpreted as disposed on a first side, [0085] & Fig. 15), and wherein an adhesive coating is disposed on a second side of the backing portion (the side of the adhesive backing containing the adhesive is being interpreted as the second side, [0085]), the adhesive coating configured to affix the duration monitor device to a surface of the IV component (the adhesive backing used to apply the light sensitive strip to device 10, [0085] & Fig. 13).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783