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 .
Information Disclosure Statement
The information disclosure statement (IDS) filed April 4th, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the examiner.
Response to Amendment
The amendment filed April 4th, 2026 has been entered. Claims 21, 24-40 remain pending in the application. Claims 22 and 23 have been cancelled by the applicant. Applicant’s amendments to the claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed January 7th, 2026.
Response to Arguments
Applicant’s amendments to claim 36 a sufficient to traverse the rejection under 35 U.S.C. § 101 set forth in the previous office action. The rejection under 35 U.S.C. § 101 is withdrawn.
Applicant’s arguments with respect to the rejection of claim 21 under 35 U.S.C. § 102(a)(1) have been considered but are moot because the limitations of the claims have been amended to add new issues. New grounds of rejection have been issued.
Applicant argues that Kagan (US 20100020846 A1) fails to disclose indicator of claim 21 and the shell of claim 37, stating on page 7 of the remarks filed April 7th, 2026 that “[…] Kagan does not clearly disclose that the indicator is configured to be immersed and freely moveable in the perishable product […]” and on page 6 of said Remarks that “[…] Kagan does not disclose a method which includes molding a shell such that the shell encapsulates the indicator means […]”.
As cited in the previous Office Action and restated below, Kagan teaches in figure 4 and at least paragraphs 12-17, 76, and 92 that insoluble container 30 (which could include glass beads, plastic tubes, or plastic spheres) comprising indicator means 10 can be compatibly immersed in a vial containing a fluid such as a vaccine dose.
The words of the claims are given their plain meaning under the broadest reasonable interpretation as would be understood by a person having ordinary skill in the art (MPEP 2111.01(I)). In the present instance one of ordinary skill in the art would understand that Kagan explicitly teaches insoluble container 30 to be immersible in a fluid container and accordingly freely movable within said container. Furthermore, one of ordinary skill would understand that Kagan explicitly teaches molding insoluble container 30 into the form of glass beads, plastic tubes, or plastic spheres as they are standard molded container forms.
In response to the arguments of pages 8-9 of the Remarks, it is cited in the 35 U.S.C. 103 rejection of the prior action (and again below) that Kagan discloses the indicator “being immersed and freely movable” and Patel (US 20130068155 A1) further teaches “a second substance” as claimed in amended claim 21.
In response to applicant's argument that the examiner's conclusion of obviousness to combine Kagan and Patel is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the present instance, it would have been obvious to include a second substance as taught by Patel in the immersible and freely movable indicator of Kagan to produce a perishable product indicator with a greater variety of displayable conditions to better inform a user of the perishable product’s status (See Patel par.’s 3-5 and par.’s 93-97).
Accordingly, amended claims 21 and 37 are rejected as cited below.
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.
Claims 21, 24-26, and 29-40 are rejected under 35 U.S.C. 103 as being unpatentable over Kagan (US 20100020846 A1) further in view of Patel (US 20130068155 A1).
Regarding Claim 21: Kagan discloses (in at least figures 4, the description, and the claims) an indicator for a perishable product (fig. 4 and par. 92: irreversible temperature threshold indicator 10 made of an insoluble container 30. See also par. 11 and par. 43.), the indicator comprising:
indicator means, configured to irreversibly, visually indicate an exposure to an undesired condition related to perishability of the product (fig. 4 and par. 92: colored nanosuspension 18 hermetically closed within insoluble container 30. See par. 92: “When the freeze-sensitive component 34 undergoes a freeze/thaw cycle the inherent color of the nanosuspension 18 disappears leaving the insoluble container 30 colorless.” See also par.’s 12-17); and
a fluid-tight and transparent, piecewise transparent, or translucent shell encapsulating the indicator means, (fig. 4 and par. 92: insoluble container 30. See par. 92: “irreversible temperature-threshold indicator 10 is made of an insoluble container 30. Examples of such an insoluble container 30 include hollow glass beads, small transparent plastic tubes, and transparent plastic spheres. Hermetically closed within the insoluble container 30 is an inherently colored nanosuspension 18. The insoluble container 30 is constructed of materials that allow it to be compatibly placed inside a vessel 32 such as a vial containing a freeze-sensitive component 34 such as a vaccine dose.” See also par. 76.);
wherein the indicator is configured to be immersed and freely-moveable in the perishable product (fig. 4 and par. 92: “insoluble container 30 is constructed of materials that allow it to be compatibly placed inside a vessel 32 such as a vial containing a freeze-sensitive component 34 such as a vaccine dose.”),
wherein the indicator means comprises a first substance, the first substance being configured to change color and/or opacity when exposed to a first undesired condition (fig. 4 and par. 92: colored nanosuspension 18 hermetically closed within insoluble container 30. See par. 92: “When the freeze-sensitive component 34 undergoes a freeze/thaw cycle the inherent color of the nanosuspension 18 disappears leaving the insoluble container 30 colorless.” See also par.’s 12-17).
Kagan does not explicitly disclose the indicator means comprises a second substance.
Patel discloses an analogous art (at least fig.’s 1-9, abstract, par. 78, par. 93, and claim 138: time temperature indicator for perishable products) wherein the indicator means comprises a first substance, the first substance being configured to change color and/or opacity when exposed to a first undesired condition and wherein the indicator means comprises a second substance, the second substance being configured to change color and/or opacity when exposed to a second undesired condition, the second undesired condition being different from the first undesired condition, or the second substance being configured to change color and/or opacity when exposed to a first undesired condition for a minimal, defined or desired time duration different from that of the first substance (fig.’s 1-2 and par.’s 93-94: Gel or fluid freeze indicating formulation 130. See par. 96: “formulation 130 can be composed of an indicating compound, such as one or more diacetylenes 131, nucleating agent 132, a solvent or a liquid medium 133, a catalyst 134 for polymerization of diacetylenes, a precursor 135 for the catalyst, a promoter 136 for the catalyst and a polymeric binder 137.” See also fig. 8 and par.’s 97-99: Formulation indicates temperature and exposure time based on polymerization of multiple diacetylene and colored catalyst compounds. A subset of compounds polymerize to display one distinct color (such as blue) at lower, freezing temperatures and another distinct color (such as red) when exposed to higher, melting/thawing temperatures. The intensities of the displayed color indicates the duration of the exposure.)
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the second substances, as taught by Patel, to be included along with the first substance in the indicator of Kagan to display a greater variety of conditions clearly and concisely along with the duration of their occurrence thereby better informing the user of the perishable substance’s quality and risk of damage (Patel par.’s 3-5 and par.’s 93-97).
Regarding Claim 24: Kagan and Patel disclose the indicator of claim 21, and Kagan discloses wherein the first substance individually comprises any one of a granular material, a porous material, a fluid or a combination thereof (fig. 4 and par. 92: colored nanosuspension 18 hermetically closed within insoluble container 30. See also par. 43 and par. 73: Nanosuspension 18 comprises nanoparticles suspended in a liquid medium.).
Kagan does not disclose a second substance.
Patel discloses an analogous art (at least fig.’s 1-9, abstract, par. 78, par. 93, and claim 138: time temperature indicator for perishable products) comprising a substance and a further substance individually comprising any one of a granular material, a porous material, a fluid or a combination thereof (fig.’s 1-2 and par.’s 93-97: Gel or fluid freeze indicating formulation 130.).
The rationale to combine is the same as for claim 21.
Regarding Claim 25: Kagan in view of Patel discloses the indicator of claim 21, and Kagan further discloses wherein the first and second undesired conditions include a temperature or a pressure outside an acceptable range, or a light with an undesirable wavelength (par. 92: “The insoluble container 30 is constructed of materials that allow it to be compatibly placed inside a vessel 32 such as a vial containing a freeze-sensitive component 34 such as a vaccine dose. When the freeze-sensitive component 34 undergoes a freeze/thaw cycle the inherent color of the nanosuspension 18 disappears leaving the insoluble container 30 colorless.” See also par.’s 12-17: “ […] the present invention provides an irreversible indicator of coolness which will detect whether an article has been subjected to temperatures below a predetermined threshold of coolness such as a freeze/thaw cycle” ).
Regarding Claim 26: Kagan and Patel disclose the indicator of claim 21, and Patel further discloses wherein the indicator indicates both that one of the first and second undesired conditions has occurred and whether one of the first and second undesired conditions has persisted long enough for the perishable product to be spoiled (fig.’s 1-2 and par.’s 93-94: Gel or fluid freeze indicating formulation 130. See par. 96: “formulation 130 can be composed of an indicating compound, such as one or more diacetylenes 131, nucleating agent 132, a solvent or a liquid medium 133, a catalyst 134 for polymerization of diacetylenes, a precursor 135 for the catalyst, a promoter 136 for the catalyst and a polymeric binder 137.” See also fig. 8 and par.’s 97-99: Formulation indicates temperature and exposure time based on polymerization of multiple diacetylene and colored catalyst compounds. A subset of compounds polymerize to display one distinct color (such as blue) at lower, freezing temperatures and another distinct color (such as red) when exposed to higher, melting/thawing temperatures. The intensities of the displayed color indicates the duration of the exposure. See also fig. 10.).
The rationale to combine is the same as for claim 21.
Regarding Claim 29: Kagan and Patel disclose the indicator of claim 21, and Kagan further discloses wherein the shell comprises a glass or a polymer (fig. 4 and par. 92: insoluble container 30. See par. 92: “irreversible temperature-threshold indicator 10 is made of an insoluble container 30. Examples of such an insoluble container 30 include hollow glass beads, small transparent plastic tubes, and transparent plastic spheres.”).
Regarding Claim 30: Kagan and Patel disclose the indicator of claim 21, and Kagan further discloses wherein the indicator comprises a spherical shape, a cylindrical shape, a ring shape, a conical shape or a cuboid shape (fig. 4 and par. 92: insoluble container 30. See par. 92: “irreversible temperature-threshold indicator 10 is made of an insoluble container 30. Examples of such an insoluble container 30 include hollow glass beads, small transparent plastic tubes, and transparent plastic spheres.”).
Regarding Claim 31: Kagan and Patel disclose at least one indicator according to claim 21, and Kagan further discloses a container for a perishable product (fig. 4 and par. 92: vessel 32 containing freeze-sensitive component 34), the container comprising:
a chamber, configured to hold the perishable product; and
wherein the at least one indicator is located within the chamber so as to be freely moveable therein (fig. 4 and par. 92: “The insoluble container 30 is constructed of materials that allow it to be compatibly placed inside a vessel 32 such as a vial containing a freeze-sensitive component 34 such as a vaccine dose. When the freeze-sensitive component 34 undergoes a freeze/thaw cycle the inherent color of the nanosuspension 18 disappears leaving the insoluble container 30 colorless.” See also the rejection of claim 21 as cited above.).
Regarding Claim 32: Kagan and Patel disclose the container of claim 31, and Kagan discloses wherein the chamber further comprises a perishable product, the perishable product comprising: a medical fluid, or a food product (fig. 4 and par. 92: vessel 32 containing freeze-sensitive component 34 “such as a vaccine dose.” See also par. 5: “Other examples where cooling beyond the freezing point has a detrimental effect include, foods such as mayonnaise, fabric softeners, latex products such as paints, concrete modifiers, laboratory supplies. Biological samples such as whole blood, insulin and the like can be seriously affected or lost when subjected to freezing conditions, and this is also true for high value biotechnology drugs containing proteins, enzymes or peptides.” ).
Regarding Claim 33: Kagan and Patel disclose the container of claim 31, and Kagan discloses wherein the chamber comprises a perishable product, the perishable product being insulin (fig. 4 and par. 92: vessel 32 containing freeze-sensitive component 34. Paragraph 5 explicitly discloses insulin as a freeze-sensitive component: “Other examples where cooling beyond the freezing point has a detrimental effect include, foods […] Biological samples such as whole blood, insulin and the like can be seriously affected or lost when subjected to freezing conditions, and this is also true for high value biotechnology drugs containing proteins, enzymes or peptides.” Kagan explicitly teaches that insulin is a perishable product with a freeze-thaw cycle that needs to be monitored and discloses an indicator configured to monitor said freeze-thaw cycle.).
Regarding Claim 34: Kagan and Patel discloses the container of claim 31, and Kagan further discloses wherein the container comprises either of a bag, a vial, a bottle, a box, a cartridge, a syringe, or an injector pen (fig. 4 and par. 92: vessel 32 containing freeze-sensitive component 34 may be a vial containing a vaccine dose. See also par. 5: indicator is configured to be compatible with vessels containing, transporting, and administering food products, biological samples such as blood, insulin, and biotechnology products. Containers of said products includes bags, vials, boxes, cartridges, syringes, and injector pens as standard.).
Regarding Claim 35: Kagan and Patel discloses the container of claim 31, and Kagan further discloses wherein the chamber is closed and sealed (fig. 4 and par. 92: vessel 32 containing freeze-sensitive component 34 may be a vial containing a vaccine dose. A vial containing a vaccine does is closed and sealed by a lid as standard. See also par. 5: indicator is configured to be compatible with vessels containing, transporting, and administering food products, biological samples such as blood, insulin, and biotechnology products. Containers of said products includes bags, vials, boxes, cartridges, syringes, and injector pens that are closed and sealed by respective lids as standard.).
Regarding Claim 36: Kagan and Patel disclose the indicator according to claim 21, and Kagan further discloses a method of transport or storage of a perishable product (fig. 4 and par. 92: vessel 32 containing freeze-sensitive component 34), the method comprising,
Providing a container comprising (i) a chamber configured to hold the perishable product and (ii) wherein the indicator is located within the chamber and is freely moveable therein (fig. 4 and par. 92: “The insoluble container 30 is constructed of materials that allow it to be compatibly placed inside a vessel 32 such as a vial containing a freeze-sensitive component 34 such as a vaccine dose. When the freeze-sensitive component 34 undergoes a freeze/thaw cycle the inherent color of the nanosuspension 18 disappears leaving the insoluble container 30 colorless.” See also the rejection of claim 21 as cited above.),
and transporting or storing perishable product in the container, wherein the perishable product comprises: a medical fluid; or a food product (fig. 4 and par. 92: vessel 32 containing freeze-sensitive component 34 “such as a vaccine dose.” See also par. 5: “Other examples where cooling beyond the freezing point has a detrimental effect include, foods such as mayonnaise, fabric softeners, latex products such as paints, concrete modifiers, laboratory supplies. Biological samples such as whole blood, insulin and the like can be seriously affected or lost when subjected to freezing conditions, and this is also true for high value biotechnology drugs containing proteins, enzymes or peptides.”).
Regarding Claim 37: Kagan and Patel disclose a method of producing an indicator according to claim 21, and Kagan further discloses the method comprising: providing indicator means, configured to indicate an exposure to an undesired condition (fig. 4 and par. 92: colored nanosuspension 18 hermetically closed within insoluble container 30. See par. 92: “When the freeze-sensitive component 34 undergoes a freeze/thaw cycle the inherent color of the nanosuspension 18 disappears leaving the insoluble container 30 colorless.” See also par.’s 12-17); and molding a shell such that the shell encapsulates the indicator means (fig. 4 and par. 92: insoluble container 30. See par. 92: “irreversible temperature-threshold indicator 10 is made of an insoluble container 30. Examples of such an insoluble container 30 include hollow glass beads, small transparent plastic tubes, and transparent plastic spheres. Hermetically closed within the insoluble container 30 is an inherently colored nanosuspension 18. The insoluble container 30 is constructed of materials that allow it to be compatibly placed inside a vessel 32 such as a vial containing a freeze-sensitive component 34 such as a vaccine dose.” See also par. 76.).
Regarding Claim 38: Kagan and Patel disclose the method of claim 37, and Kagan discloses the method further comprising: providing a container comprising a chamber (fig. 4 and par. 92: vessel 32 containing freeze-sensitive component 34 “such as a vaccine dose.” See also par. 5: “Other examples where cooling beyond the freezing point has a detrimental effect include, foods such as mayonnaise, fabric softeners, latex products such as paints, concrete modifiers, laboratory supplies. Biological samples such as whole blood, insulin and the like can be seriously affected or lost when subjected to freezing conditions, and this is also true for high value biotechnology drugs containing proteins, enzymes or peptides.” ); and inserting the indicator into the chamber so that the at least one indicator is freely moveable therein (fig. 4 and par. 92: “insoluble container 30 is constructed of materials that allow it to be compatibly placed inside a vessel 32 such as a vial containing a freeze-sensitive component 34 such as a vaccine dose.”).
Regarding Claim 39: Kagan and Patel disclose the method of claim 38, and Kagan further discloses the method further comprising: filling the container with a perishable product before the step of inserting the at least one indicator, during the step of inserting the at least one indicator, or after the step of inserting the at least one indicator; and closing and sealing the container (fig. 4 and par. 92: vessel 32 containing freeze-sensitive component 34 may be a vial containing a vaccine dose. A vial containing a vaccine does is closed and sealed by a lid as standard. See also par. 5: indicator is configured to be compatible with vessels containing, transporting, and administering food products, biological samples such as blood, insulin, and biotechnology products. Containers of said products includes bags, vials, boxes, cartridges, syringes, and injector pens that are closed and sealed by respective lids as standard.).
Regarding Claim 40: Kagan and Patel disclose the method of claim 39, and Kagan further discloses wherein the container is a cartridge, syringe or injector pen, and the perishable product is insulin fig. 4 and par. 92: vessel 32 containing freeze-sensitive component 34. Paragraph 5 explicitly discloses insulin as a freeze-sensitive component: “Other examples where cooling beyond the freezing point has a detrimental effect include, foods […] Biological samples such as whole blood, insulin and the like can be seriously affected or lost when subjected to freezing conditions, and this is also true for high value biotechnology drugs containing proteins, enzymes or peptides.” Kagan explicitly teaches that insulin is a perishable product with a freeze-thaw cycle that needs to be monitored and discloses an indicator configured to monitor said freeze-thaw cycle.).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Kagan and Patel as applied to claim 21 above, and further in view of Smith (US 20180186526 A1).
Regarding Claim 27: Kagan and Patel discloses the indicator of claim 21, but neither explicitly disclose wherein the indicator means comprises a sensor, an energy source and a light source.
Smith discloses an analogous art (fig.’s 4B-6, par.’s 47-48, and claims 18-20: tamper indicator 14’)1 wherein the indicator means comprises a sensor (fig. 5 and par. 64: sensor 58), an energy source (fig. 5 and par. 64: power source 56) and a light source, and wherein the light source is configured to provide a visual indication when the sensor detects one of the first and second undesired conditions (fig. 5 and par. 71: visible light source 64).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the sensor, energy source and light source, as taught by Smith, to be included as the indicator means of Kagan and Patel’s device to allow the indicator to be adaptable to specific undesired conditions thereby enhancing the capability of the device to monitor and provide rapid verification of the perishability condition of a specific product (Smith par.’s 2-6, par. 56, and par. 71).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Kagan and Patel as applied to claim 21 above, and further in view of Ramzan (US 20160313188 A1).
Regarding Claim 28: Kagan and Patel disclose the indicator of claim 21, but neither explicitly disclose wherein the indicator means comprises a sensor, an energy source and a wireless transmitter
Ramzan discloses an analogous art (fig.’s 1-4, abstract, and par.’s 48-51: temperature sensing device 100 for immersion in vaccine) wherein the indicator means comprises a sensor (fig. 4 and par.’s 62-64: MOS-temperature sensor 106 ) and an energy source (fig. 4, par. 49, and par. 61 The temperature-sensing device 100 is a self-powering chip which generates power by receiving the resonant power from the control device 200. The resonant receiver 102 receives the resonant wireless energy in the form of magnetic flux from the resonant coil 202 of the control device 200 and converts that flux into an electrical current using a coil within the resonant receiver 102) and a wireless transmitter (fig. 4 and par. 66: “resonant receiver circuit 102 is adapted to store the data representing the temperature measured in a memory (not shown) and send the data to the resonant reading circuit 202 via backscattering communication.”), and wherein the wireless transmitter is configured to transmit a signal when the sensor detects one of the first and second undesired conditions (par. 50: “ The temperature-sensing device 100 is adapted to be triggered for reading the temperature of the subject body at the receipt of a power load from the control device 200, where the temperature reading is reported back to the control device 200 immediately using the principle of resonant wireless energy transfer without local storage inside the device 100. A temperature history record can therefore be created over time with the various temperature readings received from the temperature sensing device 100.” See also par. 73, par. 76, and par. 78.).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for Ramazan’s sensor and energy source to be included as the indicator means of Kagan and Patel’s device to provide a smart, reusable indicators that can store and transmit temperature readings to a central control unit thereby allowing the temperature of different products across multiple containers to be monitored simultaneously and remotely (Ramzan par.’s 53-54 and par. 73).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure includes:
Ransch (US 20080296191 A1) discloses certain limitations of claims 21. 25-28, and 31-39.
Zweig (US 20070001862 A1) discloses certain limitations of claims 21. 25-28, and 31-39.
Heacock (US 20180104017 A1) discloses certain limitations of claims 21-25 and 31-39.
Fonk (US 20210215551 A1) discloses certain limitations of claims 21-25 and 31-40.
Hanlon (US 4148748 A) discloses certain limitations of claims 21. 25-28, and 31-39.
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.
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/EVAN MANCINI/Examiner, Art Unit 2855
/KRISTINA M DEHERRERA/Supervisory Patent Examiner, Art Unit 2855 5/26/26
1 See paragraph 70: Like numerals between the embodiments represent corresponding elements.
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