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) is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 36 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because it recites a process of use for an apparatus but fails to recite any steps in that process.
Step 1: Is the claim to a Process, Machine, Manufacture, or Composition of Matter?
Claim 36 recites:
“Use of an indicator according to claim 21 or of a container for transport and/or storage of a perishable product, the container comprising (i) a chamber configured to hold the perishable product and (ii) the indicator, wherein the indicator is located within the chamber being freely moveable therein, and the perishable product comprising:
a medical fluid, such as a vaccine or insulin, a biological sample, blood, a medicine, or an intravenous fluid; or
a food product, such as a dairy product, an egg-based product or a beverage.”
Claim 36 recites the distinct limitations “Use of an indicator according to claim 21” and “Use […] of a container for transport and/or storage of a perishable product, the container comprising […]” conjoined by the “or” in line 1. The examiner finds that the limitation “Use of an indicator according to claim 21” is not directed to at least one of the four categories of patent eligible subject matter.
While “the indicator according to claim 21” is an apparatus, “The use of an indicator according to claim 21” is a “Use” claim (See MPEP 2173.05(q)) that presents a new subject matter that fails to qualify as one of the four eligible statutory categories of invention, in particular a process. It has been held In re Gottschalk v. Benson that a process defines “an act, or a series of acts, performed upon the subject-matter to be transformed and reduced to a different state or thing." (Gottschalk v. Benson, 409 U.S. 63, 70, 175 USPQ 673, 676 (1972)) (See MPEP 2106.3(I.)). The “Use of an indicator” is recited without any further acts or series of acts performed upon the indicator and therefore does not qualify as a process.
Accordingly, claim 36 is rejected.
Claim Rejections - 35 USC § 112(b)
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.
Claims 34 and 35 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 34 recites the broad recitation “wherein the container comprises either of a bag, a vial, a bottle, a box, a cartridge, a syringe, or an injector pen”, and the claim also recites “and is more preferably a cartridge, syringe or injector pen.” which is the narrower statement of the range/limitation. For the purposes of examination, “the container” as claimed is interpreted to include at least any of “a bag, a vial, a bottle, a box, a cartridge, a syringe, or an injector pen” as claimed as well as any structurally equivalent means of containment.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 35, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purposes of examination, claim 35’s limitation “wherein the chamber is closed and sealed, preferably by a lid” is interpreted to encompass at least “a lid” as claimed as well as any structurally equivalent sealing and closing means.
Claim 36 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.
Claim 36 recites “Use of an indicator according to claim 21 or of a container for transport […].” The limitation “Use of an indicator according to claim 21” is indefinite for failing to particularly point out any acts or steps performed upon the indicator as claim. Recitation of only the “use” of an apparatus without any further acts or series of acts performed upon the indicator fails to distinctly claim a definitive use (See MPEP 2173.05(q)). Accordingly, claim 36 is rejected for being indefinite.
Furthermore, Claim 36 recites the limitation "Use […] of a container for transport and/or storage of a perishable product, the container comprising (i) a chamber configured to hold the perishable product and (ii) the indicator, wherein the indicator is located within the chamber […]”. “The indicator” as claimed in line 3 of claim 36 is separate from “the indicator according to claim 21” as recited in line 1. Therefore, “the indicator” of line 3 lacks antecedent basis.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 36 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 36 recites the distinct limitations “Use of an indicator according to claim 21” and “Use […] of a container for transport and/or storage of a perishable product, the container comprising […]” conjoined by the “or” in line 1. The limitation and additional elements of “Use […] of a container for transport and/or storage of a perishable product, the container comprising […]” fails to include all the limitations of claim 21, upon which claim 36 depends. The use of “or” in line 1 separate “Use of an indicator according to claim 21” which is dependent on claim 21 and the limitation and additional elements of “Use […] of a container for transport and/or storage […].” Therefore, claim 36 is rejected for presenting subject matter that fails to further limit the subject of claim 21 and fails to include all the limitations of claim 21.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102(a)(1)
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.
Claims 21-22, 25, 29-37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kagan (US 20100020846 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.”).
Regarding Claim 22: Kagan discloses the indicator of claim 21, wherein the indicator means comprises a substance, the 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).
Regarding Claim 25: Kagan discloses the indicator of claim 21, wherein the undesired conditions are 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 29: Kagan discloses the indicator of claim 21, 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 discloses the indicator of claim 21, 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 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 at least one indicator according to claim 21; wherein the at least one indicator is located within the chamber being 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 discloses the container of claim 31, wherein the chamber further comprises a perishable product, the perishable product comprising: a medical fluid, such as a vaccine, a biological sample, blood, a medicine, or an intravenous fluid; or a food product, such as a dairy product, an egg-based product or a beverage (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 discloses the container of claim 31, 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 discloses the container of claim 31, wherein the container comprises either of a bag, a vial, a bottle, a box, a cartridge, a syringe, or an injector pen, and is more preferably a cartridge, syringe or 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 discloses the container of claim 31, wherein the chamber is closed and sealed, preferably by a lid (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 discloses the use of an indicator according to claim 21 or of a container for transport and/or storage of a perishable product (fig. 4 and par. 92: vessel 32 containing freeze-sensitive component 34), the container comprising (i) a chamber configured to hold the perishable product and (ii) the indicator, wherein the indicator is located within the chamber being 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 the perishable product comprising:
a medical fluid, such as a vaccine or insulin, a biological sample, blood, a medicine, or an intravenous fluid; or a food product, such as a dairy product, an egg-based product or a beverage (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 discloses a method of producing an indicator according to claim 21, 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.).
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) 23-24, 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kagan as applied to claim 22 above, and further in view of Patel (US 20130068155 A1)
Regarding Claim 23: Kagan discloses the indicator of claim 22, but does not explicitly disclose the indicator means comprises a further 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 substance, the substance being configured to change color and/or opacity when exposed to a first undesired condition and wherein the indicator means comprises a further substance, the further substance being configured to change color and/or opacity when exposed to a further undesired condition, the further undesired condition being different from the first undesired condition, or the substance being configured to change color and/or opacity when exposed to an 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 further substances, as taught by Patel, to be included in the indicator of Kagan to display a greater 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 23, and Kagan discloses wherein the 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 further 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 23.
Regarding Claim 26: Kagan and Patel disclose the indicator of claim 21, and Patel further discloses wherein the indicator indicates both that an undesired condition has occurred and whether the undesired condition 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 23.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Kagan as applied to claim 21 above, and further in view of Smith (US 20180186526 A1).
Regarding Claim 27: Kagan discloses indicator of claim 21, but does not 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 (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 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 as applied to claim 21 above, and further in view of Ramzan (US 20160313188 A1).
Regarding Claim 28: Kagan discloses the indicator of claim 21, but does not 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 an undesired condition (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 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).
Claims 38-40 are rejected under 35 U.S.C. 103 as being unpatentable over Kagan as applied to claim 37 above, and further in view of Grabiner (US 20150090623 A1).
Regarding Claim 38: Kagan discloses method of claim 37, 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 at least one 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.”).
Kagan does not explicitly disclose the method further comprising optionally, sterilizing the at least one indicator and/or the container.
Grabiner discloses an analogous method, (at least fig.’s 1-8, abstract, and par.’s 3-5: condition indicator for containers of perishable products) comprising optionally, sterilizing the at least one indicator and/or the container (par. 132: “The indicators described herein can be sterilized by conventional methods without degrading or otherwise damaging them. Further, the indicator caps described herein can be sterilized by conventional methods without degrading or otherwise damaging the freeze indicator. Convention sterilization methods can include, but are not limited to sonication, gamma radiation, ethylene oxide sterilization, autoclave, and the like.”).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for Kagan’s indicators to be optionally sterilized, as taught by Grabiner, to prepare them for use within containers of medical compositions thereby preventing instances of contamination and enhancing the overall efficacy of an indicator designed to assist in the protection of materials administered to medical patients (Grabiner par.’s 39-43 and par. 132).
Regarding Claim 39: Kagan and Grabiner disclose the method of claim 38, and Grabiner 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 Grabiner disclose the method of claim 39, and Grabiner 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.).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EVAN MANCINI whose telephone number is (703)756-5796. The examiner can normally be reached Mon-Fri 8AM-5PM.
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/EVAN MANCINI/Examiner, Art Unit 2855
/KRISTINA M DEHERRERA/Supervisory Patent Examiner, Art Unit 2855
1/5/26
1 See paragraph 70: Like numerals between the embodiments represent corresponding elements.