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 May 07th, 2026 has been entered. Claims 1-2, 5-17, and 20-22 remain pending in the application. The amendments to the claims have overcome each and every claim objection and 112(f) interpretation previously cited in the Non-Final rejection mailed December 18th, 2025. However, the amendment has raised other issues detailed below.
Claim Objections
Claims 12 and 20 are objected to because of the following informalities:
Claim 12, line 1: “the applicator radiation shield” should read “the applicator receiving radiation shield”
Claim 20, lines 18-19: “a syringe shield for attenuating radiation from syringe containing radioactive materials stored in a syringe received within the syringe shield” should read “a syringe shield for attenuating radiation from a syringe containing radioactive materials stored in the syringe received within the syringe shield”
Appropriate correction is required.
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 2, 11-13, and 20 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.
Claim 2 recites the limitation "the vile receiver” in line 3. There is insufficient antecedent basis for this limitation in the claim. The Examiner recommends changing “the vile receiver” in line 3 of claim 2 to “the first vial receiver” which is given proper antecedent basis in line 9 of claim 1 from which claim 2 depends. For purposes of examination, the Examiner will interpret the vile receiver and the first vial receiver to be the same components.
Claim 11 recites the limitation "the radiation shield" in lines 4-5 and 5. There is insufficient antecedent basis for this limitation in the claim. The Examiner recommends changing “the radiation shield” in lines 4-5 and 5 of claim 11 to “the applicator receiving radiation shield” which is given proper antecedent basis in lines 1-2 of claim 11. For purposes of examination, the Examiner will interpret the radiation shield and the applicator receiving radiation shield to be the same components.
The term “relatively” in claim 13 is a relative term which renders the claim indefinite. The term “relatively” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The degree to which the proximal end of the two tubular passageways is raised is rendered indefinite by the use of the term “relatively”. For purposes of examination, the Examiner will interpret the claim to simply require any angle between the proximal end of the two tubular passageways and the distal end of the two tubular passageways.
Claim 20 recites the limitation "the vial" in twice in line 12 and once in line 14. There is insufficient antecedent basis for this limitation in the claim. The Examiner recommends changing the recitations of “the vial” in claim 20 to “the first vial” which is given proper antecedent basis in line 11 of claim 20. For purposes of examination, the Examiner will interpret the vial and the first vial to be the same components.
Claim 20 recites the limitation "the vial receiver" in in line 17 and in line 23. There is insufficient antecedent basis for this limitation in the claim. The Examiner recommends changing the recitations of “the vial receiver” in claim 20 to “the first vial receiver” which is given proper antecedent basis in line 8 of claim 20. For purposes of examination, the Examiner will interpret the vial receiver and the first vial receiver to be the same components.
Claim 20, lines 20-22 recite, “wherein when the syringe is received within the syringe shield, a syringe locking mechanism including a fastener for engaging the syringe, the casing and the syringe receiver through the syringe shield and engaged with the syringe” which is unclear to the Examiner as to what component is disposed “through the syringe shield and engaged with the syringe” further, the Examiner cautions the Applicant to ensure the claimed limitation is not written as a method step in an apparatus claim. For purposes of examination, the Examiner will interpret the limitation to simply require a syringe locking mechanism.
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.
Claims 21-22 are 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. Claims 21-22 recite, “The chiller of claim 19,” which fails to include all the limitations of the claim upon which it depends as claim 19 has been canceled, further, claims 19 was directed to the container of claim 18, which has also been canceled, not a chiller. 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. For purposes of examination, the Examiner will interpret claims 21-22 to depend from claim 20 which is directed to a chiller.
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.
Claims 1 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kindman et al. (5,529,391), hereinafter Kindman.
Regarding claim 1, Kindman discloses a chiller for maintaining medical materials at a temperature below ambient room temperature (Fig. 1, stirring and heating/cooling apparatus 10; Col. 1, lines 11-16 and 42-49, The present invention relates to a magnetic stirring and heating/cooling apparatus, and more particularly to a device providing for simultaneous stirring and thermostating of a plurality of biological samples for use in optical spectroscopy and other applications requiring precise temperature control accompanied by continuous stirring…A temperature sensing probe 26, most suitably an OMEGA brand RTD Sensor Part No. F3 l 02, is electrically connected to temperature control 22 so as to facilitate maintaining aluminum block 14 (and the liquid samples located in vessels therein) at a constant predetermined temperature either above or below the ambient temperature, and most preferably in the temperature range of 0° C. to 40° C), the chiller comprising:
a casing having an interior configured for receiving a plurality of components (Fig. 1, casing 12; Further, casing 12 of Kindman has the same structure as the claimed casing and is capable of functioning in the manner claimed),
a thermoelectric cooler coupled to and supported by the casing, the thermoelectric cooler including a hot side and a cold side (Fig. 2, thermoelectric elements 16; Col. 1, lines 20-30, a housing 12 which contains a heat conductive aluminum block 14 (see particularly FIGS. 2-4) defining four individual wells 14A therein. Wells 14A may be any suitable size to accommodate an optical cuvette, test tube, microcentrifuge tube or the like, and wells 14A in apparatus 10 are eighteen millimeter (mm) diameter holes which have been drilled into aluminum block 14. Thermoelectric elements 16 are secured to each of the four sides of aluminum block 14 so as to heat aluminum block 14 above ambient temperature or to cool aluminum block 14 below ambient temperature, as desired),
a fluid mover for moving fluid into thermal contact with the hot side to remove heat from the hot side (Fig. 2, fan 2; Col. 1, lines 32-35, Metal fins 18 are secured to the outside surface of thermoelectric elements 16 to facilitate dissipation of heat from thermoelectric elements 16 be as air is pulled therethrough by fan 20),
a first vial receiver in thermal contact with the cold side of the thermoelectric cooler, the first vial receiver being configured for receiving a first vial having an interior configured for receiving medical material (Fig. 1, vessels V; See annotated Fig. 2 of Kindman below, first via receiver 14a-1; Col. 1, lines 20-30 and 51-59, a housing 12 which contains a heat conductive aluminum block 14 (see particularly FIGS. 2-4) defining four individual wells 14A therein. Wells 14A may be any suitable size to accommodate an optical cuvette, test tube, microcentrifuge tube or the like, and wells 14A in apparatus 10 are eighteen millimeter (mm) diameter holes which have been drilled into aluminum block 14. Thermoelectric elements 16 are secured to each of the four sides of aluminum block 14 so as to heat aluminum block 14 above ambient temperature or to cool aluminum block 14 below ambient temperature, as desired…The vessels used to contain the specimens may be optical cuvettes, microcentrifuge tubes or any other type of vessel wherein the sample is required to be simultaneously stirred and thermostatically temperature controlled for subsequent analysis by optical spectroscopy or any other type of analysis requiring samples subjected to precise temperature control accompanied by continuous stirring),
a second vial receiver in thermal contact with the cold side of the thermoelectric cooler, the second vial receiver being configured for receiving a second vial having an interior configured for receiving medical material (Fig. 1, vessels V; See annotated Fig. 2 of Kindman below, second via receiver 14a-2; Col. 1, lines 20-30 and 51-59, a housing 12 which contains a heat conductive aluminum block 14 (see particularly FIGS. 2-4) defining four individual wells 14A therein. Wells 14A may be any suitable size to accommodate an optical cuvette, test tube, microcentrifuge tube or the like, and wells 14A in apparatus 10 are eighteen millimeter (mm) diameter holes which have been drilled into aluminum block 14. Thermoelectric elements 16 are secured to each of the four sides of aluminum block 14 so as to heat aluminum block 14 above ambient temperature or to cool aluminum block 14 below ambient temperature, as desired…The vessels used to contain the specimens may be optical cuvettes, microcentrifuge tubes or any other type of vessel wherein the sample is required to be simultaneously stirred and thermostatically temperature controlled for subsequent analysis by optical spectroscopy or any other type of analysis requiring samples subjected to precise temperature control accompanied by continuous stirring);
wherein the first vial receiver having a metal bottom for facilitating heat transfer between an exterior and an interior of the container (Col. 1, lines 20-30, a housing 12 which contains a heat conductive aluminum block 14 (see particularly FIGS. 2-4) defining four individual wells 14A therein. Wells 14A may be any suitable size to accommodate an optical cuvette, test tube, microcentrifuge tube or the like, and wells 14A in apparatus 10 are eighteen millimeter (mm) diameter holes which have been drilled into aluminum block 14. Thermoelectric elements 16 are secured to each of the four sides of aluminum block 14 so as to heat aluminum block 14 above ambient temperature or to cool aluminum block 14 below ambient temperature, as desired).
and
a stirrer for stirring the medical material in the first vial and/or the second vial (Fig. 2, coils 50, magnetic stirrer S; Col. 4, lines 9-30, Referring now specifically to FIGS. 1-3, 5 and 7, the stirring mechanism of apparatus 10 will be described in detail. Beneath each of four wells 14A are six spaced-apart and radially extending coils 50 (see particularly FIGS. 3 and 5). Coils 50 are secured within annular cavities C which have been machined out of the bottom surface of aluminum block 14 around the circumference of the bottom of each well 14A. Thus, six coils 50 are secured in a spaced-apart and radially extending relationship around the circumference of each of the four wells 14A so as to be capable of inducing a magnetic field within each of wells 14A. When current is applied to each of the four sets of six coils, three individual dipole magnets are created by each of the four sets of six coils 50. A three phase frequency controller 52, most suitably a MITSUBISHI Part No. FRZ024-0IK UL, is connected to coils 50 (see FIG. 7) such that the three individual dipole magnets surrounding each well 14A are energized wherein the polarity is sequentially cycled. This cycling applies a rotating but continuous magnetic field to the base of each well 14A so as to smoothly and continuously motivate magnetic stirrer S (see FIGS. 1 and 3) located at the bottom of vessel V therein).
However, Kindman does not disclose wherein the first vial receiver comprises a plastic container having a metal bottom and wherein the plastic container is comprised of a radiation attenuating material.
Kindman discloses the claimed invention except for wherein the first vial receiver comprises a plastic container having a metal bottom and wherein the plastic container is comprised of a radiation attenuating material. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the first vial receiver comprise a plastic container having a metal bottom and wherein the plastic container is comprised of a radiation attenuating material since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use or purpose MPEP 2144.07.
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Annotated Fig. 2 of Kindman
Regarding claim 15, Kindman discloses the chiller of claim 1 (see the rejection of claim 1 above)
wherein the casing includes a lower casing member, further comprising a heat sink in thermal contact with the hot side of the thermoelectric cooler (Fig. 1, casing 12, metal fins 18; Col. 1, lines 32-35, Metal fins 18 are secured to the outside surface of thermoelectric elements 16 to facilitate dissipation of heat from thermoelectric elements 16 be as air is pulled therethrough by fan 20), and
wherein the casing includes apertures for allowing cooling fluid to pass between ambient atmosphere and the interior of the casing and the heat sink (See annotated Fig. 2 of Kindman below, apertures A formed between the metal fins 18 allow cooling fluid to pass between ambient atmosphere and the interior of the casing and the heat sinks; Col. 1, lines 32-35, Metal fins 18 are secured to the outside surface of thermoelectric elements 16 to facilitate dissipation of heat from thermoelectric elements 16 be as air is pulled therethrough by fan 20).
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Annotated Fig. 2 of Kindman
Regarding claim 16, Kindman discloses the chiller of claim 15 (see the rejection of claim 15
above) wherein the fluid mover comprises an air mover for drawing ambient air into the interior of the first casing member, moving the ambient air through the apertures and into the interior of the first casing member, moving the air past the heat sink to absorb heat from the heat sink and exhausting the heated air from the casing through the apertures (Col. 1, lines 32-35, Metal fins 18 are secured to the outside surface of thermoelectric elements 16 to facilitate dissipation of heat from thermoelectric elements 16 be as air is pulled therethrough by fan 20).
Regarding claim 17, Kindman discloses the chiller of claim 16 (see the rejection of claim 16
above) further comprising a heat sink receiving chamber for encasing the heat sink (Fig. 1, frame 42; Col. 4, lines 6-8, frame 42 may be provided around the outer circumference of cooling fins 18 in the preferred embodiment of the invention as contemplated by applicants).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Kindman et al. (5,529,391), hereinafter Kindman in view of Norman et al. (US 20080087659), hereinafter Norman and Reich (US Patent No. 5,519,931), hereinafter Reich.
Regarding claim 2, Kindman discloses the chiller of claim 1 (see the rejection of claim 1 above).
However, Kindman does not disclose further comprising at least one syringe configured for emitting medical materials to a patient and the chiller includes at least one syringe receiver separate from the vile receiver in thermal contact with the thermoelectric cooler for maintaining medical materials in the applicator below ambient temperature.
Norman teaches a chiller that can be used to cool both vials and applicators further comprising at least one syringe configured for emitting medical materials to a patient and the chiller includes at least one emitting receiver separate from the vile receiver in thermal contact with the thermoelectric cooler for maintaining medical materials in the applicator below ambient temperature (Fig. 8, collar 72c, flaps 88, container 18, feeding syringe 90; Fig. 12, well 14a-14d, Peltier module 100; Pg. 4, paragraph 35, As shown in FIG. 7, flaps 88 are flexible and allow the insertion of variously sized objects, such as container 18 (FIG. 7), and/or feeding syringe 90 (FIG. 8) into collar 72c. It will be appreciated by those skilled in the art that collar 72c is most beneficially made from a flexible plastic or rubber, such as neoprene or polyethylene or polypropylene which is selected to provide a sufficient degree of flexibility so that variously sized objects may be supported within collar 72c by flaps 88. In this manner, variously sized devices may be supported by collar 72c, as well as oddly or asymmetrically shaped devices. It should further be appreciated that the materials for a construction of collar 72a and/or 72b may be less flexible than the most desirable materials used to construct collar 72c. By contrast, collar 72a and 72b do not require the degree of flexibility which is desirable for flaps 88 of collar 72c, rather, collars 72a, 72b may be of a more rigid nature as they are generally designed to accommodate the particular container size 18 being employed by the user of device 10; Pg. 5, paragraph 40, In FIG. 12 and alternate device for heating and cooling well 14a-14d is shown. A peltier thermoelectric module 100 operating on 12 volts direct current is mounted in contact with well 14a-14d. Peltier modules are semi-conductor elements which allow cooling, heating and temperature regulation through direct current electricity. By putting a direct current through a peltier module, a temperature difference develops on the sides of the unit. The low temperature side absorbs heat, and the high temperature side radiates heat, transferring heat from the low to the high temperature side of the peltier module. By changing the polarity of the current, the direction of heat flow can be changed. Also, by altering the size of the current it is possible to change the amount of heat transfer. By connecting a peltier module 100 to a metallic well 14a-14d a single structure can be used to heat and cool the contents of well 14a-14d).
Therefore, it would have been obvious before the effective filing date of the claimed invention to modify the chiller of Kindman of claim 1 to be used to cool both vials and syringes at least one syringe configured for emitting medical materials to a patient and the chiller includes at least one emitting receiver separate from the vile receiver in thermal contact with the thermoelectric cooler for maintaining medical materials in the applicator below ambient temperature as taught by Norman. One of ordinary skill in the art would have been motivated to make this modification to provide a sufficient degree of flexibility so that variously sized objects may be supported the chiller (Norman, Pg. 4, paragraph 35).
Further, Kindman as modified does not explicitly disclose the at least one syringe to be configured for applying radiation emitting medical materials to a patient.
Reich teaches the at least one syringe to be configured for applying radiation emitting medical materials to a patient (Fig. 1, syringe 14; Col. 6, line 9, syringe 14 holding a radioactive drug).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute the known element of generic syringe of Kindman as modified with the at least one syringe configured for applying radiation emitting medical materials to a patient of Reich as it has been shown that a simple substitution of one known element for another to yield predictable results is obvious syringes configured for applying radiation emitting medical materials to a patient is known to be useable for brachytherapy it would have been prima facie obvious to have used the at least one syringe configured for applying radiation emitting medical materials to a patient according to claim 2 of Kindman as modified for the predictable result of administering radioactive treatment to a patient.
Claims 5, 10, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kindman et al. (5,529,391), hereinafter Kindman in view of Norman et al. (US 20080087659), hereinafter Norman.
Regarding claim 5, Kindman discloses a chiller for maintaining medical materials at a temperature below ambient room temperature (Fig. 1, stirring and heating/cooling apparatus 10; Col. 1, lines 11-16 and 42-49, The present invention relates to a magnetic stirring and heating/cooling apparatus, and more particularly to a device providing for simultaneous stirring and thermostating of a plurality of biological samples for use in optical spectroscopy and other applications requiring precise temperature control accompanied by continuous stirring…A temperature sensing probe 26, most suitably an OMEGA brand RTD Sensor Part No. F3 l 02, is electrically connected to temperature control 22 so as to facilitate maintaining aluminum block 14 (and the liquid samples located in vessels therein) at a constant predetermined temperature either above or below the ambient temperature, and most preferably in the temperature range of 0° C. to 40° C), the chiller comprising:
a. a casing having an interior configured for receiving a plurality of components (Fig. 1, casing 12; Further, casing 12 of Kindman has the same structure as the claimed casing and is capable of functioning in the manner claimed),
b. a thermoelectric cooler coupled to and supported by the casing, the thermoelectric cooler including a hot side and a cold side (Fig. 2, thermoelectric elements 16; Col. 1, lines 20-30, a housing 12 which contains a heat conductive aluminum block 14 (see particularly FIGS. 2-4) defining four individual wells 14A therein. Wells 14A may be any suitable size to accommodate an optical cuvette, test tube, microcentrifuge tube or the like, and wells 14A in apparatus 10 are eighteen millimeter (mm) diameter holes which have been drilled into aluminum block 14. Thermoelectric elements 16 are secured to each of the four sides of aluminum block 14 so as to heat aluminum block 14 above ambient temperature or to cool aluminum block 14 below ambient temperature, as desired),
c. a fluid mover for moving fluid into thermal contact with the hot side to remove heat from the hot side (Fig. 2, fan 2; Col. 1, lines 32-35, Metal fins 18 are secured to the outside surface of thermoelectric elements 16 to facilitate dissipation of heat from thermoelectric elements 16 be as air is pulled therethrough by fan 20),
d. a first vial receiver in thermal contact with the cold side of the thermoelectric cooler, the first vial receiver being configured for receiving a first vial having an interior configured for receiving medical material (Fig. 1, vessels V; See annotated Fig. 2 of Kindman below, first via receiver 14a-1; Col. 1, lines 20-30 and 51-59, a housing 12 which contains a heat conductive aluminum block 14 (see particularly FIGS. 2-4) defining four individual wells 14A therein. Wells 14A may be any suitable size to accommodate an optical cuvette, test tube, microcentrifuge tube or the like, and wells 14A in apparatus 10 are eighteen millimeter (mm) diameter holes which have been drilled into aluminum block 14. Thermoelectric elements 16 are secured to each of the four sides of aluminum block 14 so as to heat aluminum block 14 above ambient temperature or to cool aluminum block 14 below ambient temperature, as desired…The vessels used to contain the specimens may be optical cuvettes, microcentrifuge tubes or any other type of vessel wherein the sample is required to be simultaneously stirred and thermostatically temperature controlled for subsequent analysis by optical spectroscopy or any other type of analysis requiring samples subjected to precise temperature control accompanied by continuous stirring),
e. a second vial receiver in thermal contact with the cold side of the thermoelectric cooler, the second vial receiver being configured for receiving a second vial having an interior configured for receiving medical material (Fig. 1, vessels V; See annotated Fig. 2 of Kindman below, second via receiver 14a-2; Col. 1, lines 20-30 and 51-59, a housing 12 which contains a heat conductive aluminum block 14 (see particularly FIGS. 2-4) defining four individual wells 14A therein. Wells 14A may be any suitable size to accommodate an optical cuvette, test tube, microcentrifuge tube or the like, and wells 14A in apparatus 10 are eighteen millimeter (mm) diameter holes which have been drilled into aluminum block 14. Thermoelectric elements 16 are secured to each of the four sides of aluminum block 14 so as to heat aluminum block 14 above ambient temperature or to cool aluminum block 14 below ambient temperature, as desired…The vessels used to contain the specimens may be optical cuvettes, microcentrifuge tubes or any other type of vessel wherein the sample is required to be simultaneously stirred and thermostatically temperature controlled for subsequent analysis by optical spectroscopy or any other type of analysis requiring samples subjected to precise temperature control accompanied by continuous stirring).
However, Kindman does not disclose further comprising at least one applicator configured for
applying medical materials to a patient and the chiller casing includes at least one applicator receiver in thermal contact with the thermoelectric cooler for maintaining medical materials in the applicator below ambient temperature.
Norman teaches a chiller that can be used to cool both vials and applicators further comprising
at least one applicator configured for applying medical materials to a patient and the chiller casing includes at least one applicator receiver in thermal contact with the thermoelectric cooler for maintaining medical materials in the applicator below ambient temperature (Fig. 8, collar 72c, flaps 88, container 18, feeding syringe 90; Fig. 12, well 14a-14d, Peltier module 100; Pg. 4, paragraph 35, As shown in FIG. 7, flaps 88 are flexible and allow the insertion of variously sized objects, such as container 18 (FIG. 7), and/or feeding syringe 90 (FIG. 8) into collar 72c. It will be appreciated by those skilled in the art that collar 72c is most beneficially made from a flexible plastic or rubber, such as neoprene or polyethylene or polypropylene which is selected to provide a sufficient degree of flexibility so that variously sized objects may be supported within collar 72c by flaps 88. In this manner, variously sized devices may be supported by collar 72c, as well as oddly or asymmetrically shaped devices. It should further be appreciated that the materials for a construction of collar 72a and/or 72b may be less flexible than the most desirable materials used to construct collar 72c. By contrast, collar 72a and 72b do not require the degree of flexibility which is desirable for flaps 88 of collar 72c, rather, collars 72a, 72b may be of a more rigid nature as they are generally designed to accommodate the particular container size 18 being employed by the user of device 10; Pg. 5, paragraph 40, In FIG. 12 and alternate device for heating and cooling well 14a-14d is shown. A peltier thermoelectric module 100 operating on 12 volts direct current is mounted in contact with well 14a-14d. Peltier modules are semi-conductor elements which allow cooling, heating and temperature regulation through direct current electricity. By putting a direct current through a peltier module, a temperature difference develops on the sides of the unit. The low temperature side absorbs heat, and the high temperature side radiates heat, transferring heat from the low to the high temperature side of the peltier module. By changing the polarity of the current, the direction of heat flow can be changed. Also, by altering the size of the current it is possible to change the amount of heat transfer. By connecting a peltier module 100 to a metallic well 14a-14d a single structure can be used to heat and cool the contents of well 14a-14d).
Therefore, it would have been obvious before the effective filing date of the claimed invention to modify the chiller of Kindman of claim 5 to be used to cool both vials and applicators further comprising at least one applicator configured for applying medical materials to a patient and the chiller includes at least one applicator receiver in thermal contact with the thermoelectric cooler for maintaining medical materials in the applicator below ambient temperature as taught by Norman. One of ordinary skill in the art would have been motivated to make this modification to provide a sufficient degree of flexibility so that variously sized objects may be supported the chiller (Norman, Pg. 4, paragraph 35).
Regarding claim 10, Kindman discloses a chiller for maintaining medical materials at a temperature below ambient room temperature (Fig. 1, stirring and heating/cooling apparatus 10; Col. 1, lines 11-16 and 42-49, The present invention relates to a magnetic stirring and heating/cooling apparatus, and more particularly to a device providing for simultaneous stirring and thermostating of a plurality of biological samples for use in optical spectroscopy and other applications requiring precise temperature control accompanied by continuous stirring…A temperature sensing probe 26, most suitably an OMEGA brand RTD Sensor Part No. F3 l 02, is electrically connected to temperature control 22 so as to facilitate maintaining aluminum block 14 (and the liquid samples located in vessels therein) at a constant predetermined temperature either above or below the ambient temperature, and most preferably in the temperature range of 0° C. to 40° C),
the chiller comprising:
a casing having an interior configured for receiving a plurality of components (Fig. 1, casing 12; Further, casing 12 of Kindman has the same structure as the claimed casing and is capable of functioning in the manner claimed),
a thermoelectric cooler coupled to and supported by the casing, the thermoelectric cooler including a hot side and a cold side (Fig. 2, thermoelectric elements 16; Col. 1, lines 20-30, a housing 12 which contains a heat conductive aluminum block 14 (see particularly FIGS. 2-4) defining four individual wells 14A therein. Wells 14A may be any suitable size to accommodate an optical cuvette, test tube, microcentrifuge tube or the like, and wells 14A in apparatus 10 are eighteen millimeter (mm) diameter holes which have been drilled into aluminum block 14. Thermoelectric elements 16 are secured to each of the four sides of aluminum block 14 so as to heat aluminum block 14 above ambient temperature or to cool aluminum block 14 below ambient temperature, as desired),
a fluid mover for moving fluid into thermal contact with the hot side to remove heat from the hot side (Fig. 2, fan 2; Col. 1, lines 32-35, Metal fins 18 are secured to the outside surface of thermoelectric elements 16 to facilitate dissipation of heat from thermoelectric elements 16 be as air is pulled therethrough by fan 20),
a first vial receiver in thermal contact with the cold side of the thermoelectric cooler, the first vial receiver being configured for receiving a first vial having an interior configured for receiving medical material (Fig. 1, vessels V; See annotated Fig. 2 of Kindman below, first via receiver 14a-1; Col. 1, lines 20-30 and 51-59, a housing 12 which contains a heat conductive aluminum block 14 (see particularly FIGS. 2-4) defining four individual wells 14A therein. Wells 14A may be any suitable size to accommodate an optical cuvette, test tube, microcentrifuge tube or the like, and wells 14A in apparatus 10 are eighteen millimeter (mm) diameter holes which have been drilled into aluminum block 14. Thermoelectric elements 16 are secured to each of the four sides of aluminum block 14 so as to heat aluminum block 14 above ambient temperature or to cool aluminum block 14 below ambient temperature, as desired…The vessels used to contain the specimens may be optical cuvettes, microcentrifuge tubes or any other type of vessel wherein the sample is required to be simultaneously stirred and thermostatically temperature controlled for subsequent analysis by optical spectroscopy or any other type of analysis requiring samples subjected to precise temperature control accompanied by continuous stirring),
a second vial receiver in thermal contact with the cold side of the thermoelectric cooler, the second vial receiver being configured for receiving a second vial having an interior configured for receiving medical material (Fig. 1, vessels V; See annotated Fig. 2 of Kindman below, second via receiver 14a-2; Col. 1, lines 20-30 and 51-59, a housing 12 which contains a heat conductive aluminum block 14 (see particularly FIGS. 2-4) defining four individual wells 14A therein. Wells 14A may be any suitable size to accommodate an optical cuvette, test tube, microcentrifuge tube or the like, and wells 14A in apparatus 10 are eighteen millimeter (mm) diameter holes which have been drilled into aluminum block 14. Thermoelectric elements 16 are secured to each of the four sides of aluminum block 14 so as to heat aluminum block 14 above ambient temperature or to cool aluminum block 14 below ambient temperature, as desired…The vessels used to contain the specimens may be optical cuvettes, microcentrifuge tubes or any other type of vessel wherein the sample is required to be simultaneously stirred and thermostatically temperature controlled for subsequent analysis by optical spectroscopy or any other type of analysis requiring samples subjected to precise temperature control accompanied by continuous stirring).
However, Kindman does not disclose an applicator configured for applying medical materials to a patient and
an applicator receiver, the applicator receiver comprising at least one tubular passageway configured for receiving the applicator within the passageway.
Norman teaches a chiller that can be used to cool both vials and applicators further comprising an applicator configured for applying medical materials to a patient and (Fig. 8, collar 72c, flaps 88, container 18, feeding syringe 90; Fig. 12, well 14a-14d, Peltier module 100; Pg. 4, paragraph 35, As shown in FIG. 7, flaps 88 are flexible and allow the insertion of variously sized objects, such as container 18 (FIG. 7), and/or feeding syringe 90 (FIG. 8) into collar 72c. It will be appreciated by those skilled in the art that collar 72c is most beneficially made from a flexible plastic or rubber, such as neoprene or polyethylene or polypropylene which is selected to provide a sufficient degree of flexibility so that variously sized objects may be supported within collar 72c by flaps 88. In this manner, variously sized devices may be supported by collar 72c, as well as oddly or asymmetrically shaped devices. It should further be appreciated that the materials for a construction of collar 72a and/or 72b may be less flexible than the most desirable materials used to construct collar 72c. By contrast, collar 72a and 72b do not require the degree of flexibility which is desirable for flaps 88 of collar 72c, rather, collars 72a, 72b may be of a more rigid nature as they are generally designed to accommodate the particular container size 18 being employed by the user of device 10; Pg. 5, paragraph 40, In FIG. 12 and alternate device for heating and cooling well 14a-14d is shown. A peltier thermoelectric module 100 operating on 12 volts direct current is mounted in contact with well 14a-14d. Peltier modules are semi-conductor elements which allow cooling, heating and temperature regulation through direct current electricity. By putting a direct current through a peltier module, a temperature difference develops on the sides of the unit. The low temperature side absorbs heat, and the high temperature side radiates heat, transferring heat from the low to the high temperature side of the peltier module. By changing the polarity of the current, the direction of heat flow can be changed. Also, by altering the size of the current it is possible to change the amount of heat transfer. By connecting a peltier module 100 to a metallic well 14a-14d a single structure can be used to heat and cool the contents of well 14a-14d),
an applicator receiver, the applicator receiver comprising at least one tubular passageway configured for receiving the applicator within the passageway (Fig. 8, collar 72c, flaps 88; See Fig. 8 of Norman, a tubular passageway is depicted to be formed by the flaps 88 when feeding syringe 90 is inserted into the collar 72c).
Therefore, it would have been obvious before the effective filing date of the claimed invention to modify the chiller of Kindman of claim 10 to be used to cool both vials and applicators further comprising an applicator receiver and an applicator configured for applying medical materials to a patient the applicator receiver comprising at least one tubular passageway configured for receiving the applicator within the passageway as taught by Norman. One of ordinary skill in the art would have been motivated to make this modification to provide a sufficient degree of flexibility so that variously sized objects may be supported the chiller (Norman, Pg. 4, paragraph 35).
Further, it would have been prima facie obvious to one of ordinary skill in the art to form the at least one tubular passageway as part of the casing, since it has been held that forming in one piece an article that has formerly been formed in more than one piece and put together involves only routine skill in the art. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (A claim to a fluid transporting vehicle was rejected as obvious over a prior art reference which differed from the prior art in claiming a brake drum integral with a clamping means, whereas the brake disc and clamp of the prior art comprise several parts rigidly secured together as a single unit. The court affirmed the rejection holding, among other reasons, “that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice.”) MPEP 2144.04-V-B.
Regarding claim 14, Kindman discloses the chiller of claim 1 (see the rejection of claim 1 above) wherein the casing includes a first casing member for housing the fluid mover, a second casing member to which the thermoelectric cooler is mounted (Fig. 1, casing 12, frame 42).
However, Kindman does not disclose a third casing member to which an applicator receiver is coupled, the applicator receiver being in thermal contact with the thermoelectric cooler.
Norman teaches a chiller that can be used to cool both vials and applicators further comprising a third casing member to which an applicator receiver is coupled, the applicator receiver being in thermal contact with the thermoelectric cooler (Fig. 8, collar 72c, flaps 88, container 18, feeding syringe 90; Fig. 12, well 14a-14d, Peltier module 100; Pg. 4, paragraph 35, As shown in FIG. 7, flaps 88 are flexible and allow the insertion of variously sized objects, such as container 18 (FIG. 7), and/or feeding syringe 90 (FIG. 8) into collar 72c. It will be appreciated by those skilled in the art that collar 72c is most beneficially made from a flexible plastic or rubber, such as neoprene or polyethylene or polypropylene which is selected to provide a sufficient degree of flexibility so that variously sized objects may be supported within collar 72c by flaps 88. In this manner, variously sized devices may be supported by collar 72c, as well as oddly or asymmetrically shaped devices. It should further be appreciated that the materials for a construction of collar 72a and/or 72b may be less flexible than the most desirable materials used to construct collar 72c. By contrast, collar 72a and 72b do not require the degree of flexibility which is desirable for flaps 88 of collar 72c, rather, collars 72a, 72b may be of a more rigid nature as they are generally designed to accommodate the particular container size 18 being employed by the user of device 10; Pg. 5, paragraph 40, In FIG. 12 and alternate device for heating and cooling well 14a-14d is shown. A peltier thermoelectric module 100 operating on 12 volts direct current is mounted in contact with well 14a-14d. Peltier modules are semi-conductor elements which allow cooling, heating and temperature regulation through direct current electricity. By putting a direct current through a peltier module, a temperature difference develops on the sides of the unit. The low temperature side absorbs heat, and the high temperature side radiates heat, transferring heat from the low to the high temperature side of the peltier module. By changing the polarity of the current, the direction of heat flow can be changed. Also, by altering the size of the current it is possible to change the amount of heat transfer. By connecting a peltier module 100 to a metallic well 14a-14d a single structure can be used to heat and cool the contents of well 14a-14d).
Therefore, it would have been obvious before the effective filing date of the claimed invention to modify the chiller of Kindman of claim 1 to be used to cool both vials and applicators further comprising a third casing member to which an applicator receiver is coupled, the applicator receiver being in thermal contact with the thermoelectric cooler as taught by Norman. One of ordinary skill in the art would have been motivated to make this modification to provide a sufficient degree of flexibility so that variously sized objects may be supported the chiller (Norman, Pg. 4, paragraph 35).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kindman as modified by Norman as applied to claim 5 above, and further in view of Foster et al. (US Patent No. 4,062,353), hereinafter Foster and Lemer (US Patent No. 7,351,227), hereinafter Lemer.
Regarding claim 6, Kindman as modified discloses the chiller of claim 5 (see the combination of references used in the rejection of claim 5 above).
However, Kindman as modified does not explicitly disclose further comprising an applicator shield for interiorly receiving the applicator, and wherein the applicator comprises a body having an exterior surface and an interior surface for defining an interior needle engaging distal end, an open, plunger receiving proximal end, and a plunger insertable in the interior.
Foster teaches further comprising an applicator shield for interiorly receiving the applicator, and wherein the applicator comprises a body having an exterior surface and an interior surface for defining an interior needle engaging distal end, an open, plunger receiving proximal end, and a plunger insertable in the interior (Fig. 1, device 10, main barrel member 30, barrel element 12, needle 17, finder engaging flange 14, plunger 23; Fig. 2, hypodermic syringe 11; Col. 2, lines 22-28, The device 10 includes a main barrel member 30 of tungsten, tantalum, or similar radioactive shielding material. It is bounded by a proximal end 31, a distal end 32, an outer cylindrical surface 33 and an outer tapered surface 34. An elongated slot 35 is covered by a lead glass window 36 to permit volumetric calibration of the syringe 11).
Therefore, it would have been obvious before the effective filing date of the claimed invention to modify the generic applicator of Kindman as modified to include an applicator shield for interiorly receiving the applicator, and wherein the applicator comprises a body having an exterior surface and an interior surface for defining an interior needle engaging distal end, an open, plunger receiving proximal end, and a plunger insertable in the interior as taught by Foster. One of ordinary skill in the art would have been motivated to make this modification to provide radioactive syringe shield for protecting a user from radiation emanating from a radioactive material disposed within an enclosed syringe (Foster, Abstract).
Further, Kindman as modified does not disclose wherein the applicator shield includes an annular groove configured to be engaged by the user's fingers for facilitating movement of the applicator shield and the applicator.
Lemer teaches wherein the applicator shield includes an annular groove configured to be engaged by the user's fingers for facilitating movement of the applicator shield and the applicator (Fig. 1, device 1, annular hollow 19; Col. 14, lines 30-32, the annular recess 19 may then be used as resting points for the fingers, when filling the syringe or when injecting the product; Further, the annular hollow 19 of Lemer has the same structure as the claimed annular groove and is capable of functioning in the manner claimed).
Kindman as modified fails to teach wherein the applicator shield includes an annular groove configured to be engaged by the user's fingers for facilitating movement of the applicator shield and the applicator, however Lemer teaches that it is a known method in the art of radioactive syringe shielding to include wherein the applicator shield includes an annular groove configured to be engaged by the user's fingers for facilitating movement of the applicator shield and the applicator. This is strong evidence that modifying Kindman as modified as claimed would produce predictable results (i.e. providing resting points for the user’s fingers). Accordingly, 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 Kindman as modified by Lemer and arrive at the claimed invention since all claimed elements were known in the art and one having ordinary skill in the art could have combined the elements as claimed by known methods with no changes in their respective functions and the combination would have yielded the predictable result of providing resting points for the user’s fingers.
Claims 7-8 is rejected under 35 U.S.C. 103 as being unpatentable over Kindman as modified by Norman, Foster, and Lemer as applied to claim 6 above, and further in view of Yazbeck (US Patent No. 9,642,778), hereinafter Yazbeck.
Regarding claim 7, Kindman as modified discloses the chiller of claim 6 (see the combination of references used in the rejection of claim 6 above).
However, Kindman as modified does not disclose further comprising a lock configured for being engageable with the applicator, the applicator shield and applicator receiver for fixedly positioning the applicator in the applicator receiver and to the casing.
Yazbeck teaches a lock configured for being engageable with the applicator, the applicator shield applicator receiver for fixedly positioning the applicator in the applicator receiver (Fig. 1, central channel 16; Fig. 4, elongated holding element 10, syringe 60, casing 61, fastening element 65, fastener element head 66; Col. 2, lines 53-67, Referring more particularly to FIG. 4, there is shown a modified neonatal feeding syringe 60 attached to the present invention vertical holding element 10. The syringe 60 is comprised of a generally cylindrical casing 61 and a plunger 62, said plunger being removed from the casing when an actual feeding is in operation. The casing 61 has a bottom open protrusion 63 attachable to a feeding tube 64, said casing providing a gravity feed through the open protrusion 63 into and through a feeding tube 64. The casing 61 has a fastening element 65 attached to the syringe casing 61 and protruding axially away therefrom. The casing 61 is positioned against the vertical holding element front face 11. The casing fastening element 65 extends through the vertical element central channel 16 at a desired height and is grasped by a fastener element head 66 against the vertical element rear face 12; Further, the fastener element has the same structure as the claimed lock and is capable of functioning in the manner claimed).
Kindman as modified fails to teach a lock configured for being engageable with the applicator, the applicator shield and applicator receiver for fixedly positioning the applicator in the applicator receiver and to the casing, however Yazbeck teaches that it is a known method in the art of applicators to include a lock configured for being engageable with the applicator, the applicator shield applicator receiver for fixedly positioning the applicator in the applicator receiver. This is strong evidence that modifying Kindman as modified as claimed would produce predictable results (i.e. locking an applicator in place within an applicator receiver). Accordingly, 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 Kindman as modified by Yazbeck and arrive at the claimed invention since all claimed elements were known in the art and one having ordinary skill in the art could have combined the elements as claimed by known methods with no changes in their respective functions and the combination would have yielded the predictable result of locking an applicator in place within an applicator receiver.
Regarding claim 8, Kindman as modified discloses the chiller of claim 6 (see the combination of references used in the rejection of claim 6 above).
However, Kindman as modified does not disclose wherein the lock includes a slot formed at a proximal end of the applicator shield and a thumb screw insertable in the slot and engageable with the applicator shield.
Foster teaches wherein the lock includes a slot formed at a proximal end of the applicator shield and a thumb screw insertable in the slot and engageable with the applicator shield (Fig. 7, proximal end 31, screw 48, threaded bore 47, threaded shank 49; Col. 2, lines 41-47, Engagement of the portion 43 within the notch 37 aligns the portion 44 to intersect with the axis of an oppositely disposed threaded bore 47 engaging a set screw 48 having a threaded shank 49, the inner end 50 of which bears upon the outer surface 51 of the barrel 12, as best seen in FIG. 7 in the drawing).
Therefore, it would have been obvious before the effective filing date of the claimed invention to modify the applicator of the chiller of Kindman as modified wherein the lock includes a slot formed at a proximal end of the applicator shield and a thumb screw insertable in the slot and engageable with the applicator shield as taught by Foster. One of ordinary skill in the art would have been motivated to make this modification not only to distribute the stresses applied to the barrel of the syringe over a substantial area, but to coaxially align the syringe barrel and the sleeve whereby the manual manipulation of the assembled combination is facilitated (Foster, Col. 2, lines 57-51).
However, Kindman as modified does not disclose the ability to lock the applicator into the applicator receiver via the locking mechanism.
Yazbeck teaches the ability to lock the applicator into the applicator receiver via the locking mechanism (Fig. 1, central channel 16; Fig. 4, elongated holding element 10, syringe 60, casing 61, fastening element 65, fastener element head 66; Col. 2, lines 53-67, Referring more particularly to FIG. 4, there is shown a modified neonatal feeding syringe 60 attached to the present invention vertical holding element 10. The syringe 60 is comprised of a generally cylindrical casing 61 and a plunger 62, said plunger being removed from the casing when an actual feeding is in operation. The casing 61 has a bottom open protrusion 63 attachable to a feeding tube 64, said casing providing a gravity feed through the open protrusion 63 into and through a feeding tube 64. The casing 61 has a fastening element 65 attached to the syringe casing 61 and protruding axially away therefrom. The casing 61 is positioned against the vertical holding element front face 11. The casing fastening element 65 extends through the vertical element central channel 16 at a desired height and is grasped by a fastener element head 66 against the vertical element rear face 12).
Kindman as modified fails to teach the ability to lock the applicator into the applicator receiver via the lock, however Yazbeck teaches that it is a known method in the art of applicators to include the ability to lock the applicator into the applicator receiver via the lock. This is strong evidence that modifying Kindman as modified as claimed would produce predictable results (i.e. locking an applicator in place within an applicator receiver). Accordingly, 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 Kindman as modified by Yazbeck and arrive at the claimed invention since all claimed elements were known in the art and one having ordinary skill in the art could have combined the elements as claimed by known methods with no changes in their respective functions and the combination would have yielded the predictable result of locking an applicator in place within an applicator receiver.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kindman as modified by Norman, Foster, and Lemer as applied to claim 6 above, and further in view of Cowley et al. (US Patent No. 10,231,904), hereinafter Cowley.
Regarding claim 9, Kindman as modified discloses the chiller of claim 6 (see the combination of references used in the rejection of claim 6 above).
However, Kindman as modified does not disclose wherein the applicator receiver is coupled to the casing and comprises a tubular cavity having an open proximal end for receiving the applicator and a closed distal end, the proximal end of the tubular cavity being disposed at a higher position than the distal end to position an applicator placed therein at an oblique angle relative to a chiller resting surface.
Cowley teaches wherein the applicator receiver is coupled to the casing and comprises a tubular cavity having an open proximal end for receiving the applicator and a closed distal end, the proximal end of the tubular cavity being disposed at a higher position than the distal end to position an applicator placed therein at an oblique angle relative to a chiller resting surface (Fig. 1, container body 10, casing 30, vaccine gun 42; Col. 3, lines 22-37, The angled lip 34 may include at least one holster 30, such as a plurality of holsters 30, such as three holsters 30. The holster 30 may be sized to accommodate a vaccine gun 42 and may extend from an opening in the surface of the lip down into the container body 10 proximate to the interior region 9, but not into the interior region 9. The holster 30 may comprise a substantially cylindrical channel extending into the insulation 14. The channel may extend downward at an angle. In a particular embodiment, the holster channel may extend downward at an angle of about 45°. However, other angles are also envisioned. In fact, so long as the lid 12 can still be opened when a vaccine gun 42 is in the holster 30, and the holster 30 does not extend into the interior region, any angle may be used. Embodiments of the cooler may further comprise holster caps 32 configured to close over each holster 30 when the holster 30 is not in use).
Kindman as modified fails to teach wherein the applicator receiver is coupled to the casing and comprises a tubular cavity having an open proximal end for receiving the applicator and a closed distal end, the proximal end of the tubular cavity being disposed at a higher position than the distal end to position an applicator placed therein at an oblique angle relative to a chiller resting surface, however Cowley teaches that it is a known method in the art of applicator receivers to include wherein the applicator receiver is coupled to the casing and comprises a tubular cavity having an open proximal end for receiving the applicator and a closed distal end, the proximal end of the tubular cavity being disposed at a higher position than the distal end to position an applicator placed therein at an oblique angle relative to a chiller resting surface. This is strong evidence that modifying Kindman as modified as claimed would produce predictable results (i.e. reducing the overall footprint of the chiller). Accordingly, 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 Kindman as modified by Cowley and arrive at the claimed invention since all claimed elements were known in the art and one having ordinary skill in the art could have combined the elements as claimed by known methods with no changes in their respective functions and the combination would have yielded the predictable result of reducing the overall footprint of the chiller.
Further, it would have been prima facie obvious to one of ordinary skill in the art to form the applicator receiver as part of the casing, since it has been held that forming in one piece an article that has formerly been formed in more than one piece and put together involves only routine skill in the art. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (A claim to a fluid transporting vehicle was rejected as obvious over a prior art reference which differed from the prior art in claiming a brake drum integral with a clamping means, whereas the brake disc and clamp of the prior art comprise several parts rigidly secured together as a single unit. The court affirmed the rejection holding, among other reasons, “that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice.”) MPEP 2144.04-V-B.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kindman as modified by Norman as applied to claim 10 above, and further in view of Foster et al. (US Patent No. 4,062,353), hereinafter Foster and Yazbeck (US Patent No. 9,642,778), hereinafter Yazbeck.
Regarding claim 11, Kindman as modified discloses the chiller of claim 10 (see the combination of references used in the rejection of claim 10 above).
However, Kindman as modified does not disclose further comprising an applicator receiving radiation shield having a hollow interior for interiorly receiving the applicator, and an applicator lock engageable between the applicator receiving radiation shield and the applicator, for maintaining the applicator within the hollow interior of the radiation shield.
Foster teaches further comprising an applicator receiving radiation shield having a hollow interior for interiorly receiving the applicator, and an applicator locking mechanism engageable between the applicator radiation shield and the applicator, for maintaining the applicator within the hollow interior of the radiation shield (Fig. 1, device 10, main barrel member 30, barrel element 12, needle 17, finder engaging flange 14, plunger 23; Fig. 2, hypodermic syringe 11; Fig. 7, proximal end 31, screw 48, threaded bore 47, threaded shank 49; Col. 2, lines 22-28 and 41-47, The device 10 includes a main barrel member 30 of tungsten, tantalum, or similar radioactive shielding material. It is bounded by a proximal end 31, a distal end 32, an outer cylindrical surface 33 and an outer tapered surface 34. An elongated slot 35 is covered by a lead glass window 36 to permit volumetric calibration of the syringe 11…Engagement of the portion 43 within the notch 37 aligns the portion 44 to intersect with the axis of an oppositely disposed threaded bore 47 engaging a set screw 48 having a threaded shank 49, the inner end 50 of which bears upon the outer surface 51 of the barrel 12, as best seen in FIG. 7 in the drawing).
Therefore, it would have been obvious before the effective filing date of the claimed invention to modify the generic applicator of Kindman as modified to include an applicator receiving radiation shield having a hollow interior for interiorly receiving the applicator, and an applicator locking mechanism engageable between the applicator radiation shield and the applicator, for maintaining the applicator within the hollow interior of the radiation shield as taught by Foster. One of ordinary skill in the art would have been motivated to make this modification to provide radioactive syringe shield for protecting a user from radiation emanating from a radioactive material disposed within an enclosed syringe (Foster, Abstract).
Further, Kindman as modified does not disclose the radiation shield and the applicator fixedly coupled to the casing.
Yazbeck teaches fixing a shielding and applicator to a support device (Fig. 1, central channel 16; Fig. 4, elongated holding element 10, syringe 60, casing 61, fastening element 65, fastener element head 66; Col. 2, lines 53-67, Referring more particularly to FIG. 4, there is shown a modified neonatal feeding syringe 60 attached to the present invention vertical holding element 10. The syringe 60 is comprised of a generally cylindrical casing 61 and a plunger 62, said plunger being removed from the casing when an actual feeding is in operation. The casing 61 has a bottom open protrusion 63 attachable to a feeding tube 64, said casing providing a gravity feed through the open protrusion 63 into and through a feeding tube 64. The casing 61 has a fastening element 65 attached to the syringe casing 61 and protruding axially away therefrom. The casing 61 is positioned against the vertical holding element front face 11. The casing fastening element 65 extends through the vertical element central channel 16 at a desired height and is grasped by a fastener element head 66 against the vertical element rear face 12).
Kindman as modified fails to teach the radiation shield and the applicator fixedly coupled to the casing, however Yazbeck teaches that it is a known method in the art of applicators to include fixing a shielding and applicator to a support device. This is strong evidence that modifying Kindman as modified as claimed would produce predictable results (i.e. locking an applicator in place to improve user safety). Accordingly, 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 Kindman as modified by Yazbeck and arrive at the claimed invention since all claimed elements were known in the art and one having ordinary skill in the art could have combined the elements as claimed by known methods with no changes in their respective functions and the combination would have yielded the predictable result of locking an applicator in place within an applicator receiver.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Kindman as modified by Norman, Foster, and Yazbek as applied to claim 11 above, and further in view of Lemer (US Patent No. 7,351,227), hereinafter Lemer.
Regarding claim 12, Kindman as modified discloses the chiller of claim 11 (see the combination of references used in the rejection of claim 11 above), the applicator lock comprises a threaded screw having an end receivable into the applicator receiving radiation shield, and engageable with the applicator (Fig. 7, proximal end 31, screw 48, threaded bore 47, threaded shank 49; Col. 2, lines 41-47, Engagement of the portion 43 within the notch 37 aligns the portion 44 to intersect with the axis of an oppositely disposed threaded bore 47 engaging a set screw 48 having a threaded shank 49, the inner end 50 of which bears upon the outer surface 51 of the barrel 12, as best seen in FIG. 7 in the drawing). Further, the recitation, “the locking mechanism comprises a threaded screw having an end receivable into the applicator radiation shield, and engageable with the applicator” is the result of the modification of references used in the rejection of claim 11 above.
However, Kindman as modified does not disclose wherein the applicator radiation shield includes an annular groove.
Lemer teaches wherein the applicator radiation shield includes an annular groove (Fig. 1, device 1, annular hollow 19; Col. 14, lines 30-32, the annular recess 19 may then be used as resting points for the fingers, when filling the syringe or when injecting the product; Further, the annular hollow 19 of Lemer has the same structure as the claimed annular groove and is capable of functioning in the manner claimed).
Kindman as modified fails to teach wherein the applicator radiation shield includes an annular groove, however Lemer teaches that it is a known method in the art of radioactive syringe shielding to include wherein the applicator radiation shield includes an annular groove. This is strong evidence that modifying Kindman as modified as claimed would produce predictable results (i.e. providing resting points for the user’s fingers). Accordingly, 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 Kindman as modified by Lemer and arrive at the claimed invention since all claimed elements were known in the art and one having ordinary skill in the art could have combined the elements as claimed by known methods with no changes in their respective functions and the combination would have yielded the predictable result of providing resting points for the user’s fingers.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kindman as modified by Norman as applied to claim 10 above, and further in view of Cowley et al. (US Patent No. 10,231,904), hereinafter Cowley.
Regarding claim 13, Kindman as modified discloses the chiller of claim 10 (see the combination of references used in the rejection of claim 10 above) wherein the applicator receiver includes a thermally conductive support member coupled to the casing and in thermal contact with the thermoelectric cooler (Norman, Fig. 12, well 14a-14d, Peltier module 100; Pg. 5, paragraph 40, In FIG. 12 and alternate device for heating and cooling well 14a-14d is shown. A peltier thermoelectric module 100 operating on 12 volts direct current is mounted in contact with well 14a-14d. Peltier modules are semi-conductor elements which allow cooling, heating and temperature regulation through direct current electricity. By putting a direct current through a peltier module, a temperature difference develops on the sides of the unit. The low temperature side absorbs heat, and the high temperature side radiates heat, transferring heat from the low to the high temperature side of the peltier module. By changing the polarity of the current, the direction of heat flow can be changed. Also, by altering the size of the current it is possible to change the amount of heat transfer. By connecting a peltier module 100 to a metallic well 14a-14d a single structure can be used to heat and cool the contents of well 14a-14d). Further, the recitation, “wherein the applicator receiver includes a thermally conductive support member coupled to the casing and in thermal contact with the thermoelectric cooler” is the result of the modification of references used in the rejection of claim 10 above.
However, Kindman as modified does not disclose the thermally conductive support member including at least two tubular passageways configured for receiving tubular passageway containing applicators having a proximal end and a distal end, the two tubular passageways including a relatively raised proximal end for receiving the proximal end of the tubular passageway containing applicators and a distal end for receiving the distal end of the tubular passageway containing applicators, to position the tubular passageway containing applicators at an oblique angle to a resting surface upon which the chiller rests.
Cowley teaches the thermally conductive support member including at least two tubular passageways configured for receiving tubular passageway containing applicators having a proximal end and a distal end, the two tubular passageways including a relatively raised proximal end for receiving the proximal end of the tubular passageway containing applicators and a distal end for receiving the distal end of the tubular passageway containing applicators, to position the tubular passageway containing applicators at an oblique angle to a resting surface upon which the chiller rests (Fig. 1, container body 10, casing 30, vaccine gun 42; Col. 3, lines 22-37, The angled lip 34 may include at least one holster 30, such as a plurality of holsters 30, such as three holsters 30. The holster 30 may be sized to accommodate a vaccine gun 42 and may extend from an opening in the surface of the lip down into the container body 10 proximate to the interior region 9, but not into the interior region 9. The holster 30 may comprise a substantially cylindrical channel extending into the insulation 14. The channel may extend downward at an angle. In a particular embodiment, the holster channel may extend downward at an angle of about 45°. However, other angles are also envisioned. In fact, so long as the lid 12 can still be opened when a vaccine gun 42 is in the holster 30, and the holster 30 does not extend into the interior region, any angle may be used. Embodiments of the cooler may further comprise holster caps 32 configured to close over each holster 30 when the holster 30 is not in use).
Kindman as modified fails to teach the thermally conductive support member including at least two tubular passageways configured for receiving tubular passageway containing applicators having a proximal end and a distal end, the two tubular passageways including a relatively raised proximal end for receiving the proximal end of the tubular passageway containing applicators and a distal end for receiving the distal end of the tubular passageway containing applicators, to position the tubular passageway containing applicators at an oblique angle to a resting surface upon which the chiller rests, however Cowley teaches that it is a known method in the art of applicator receivers to include the thermally conductive support member including at least two tubular passageways configured for receiving tubular passageway containing applicators having a proximal end and a distal end, the two tubular passageways including a relatively raised proximal end for receiving the proximal end of the tubular passageway containing applicators and a distal end for receiving the distal end of the tubular passageway containing applicators, to position the tubular passageway containing applicators at an oblique angle to a resting surface upon which the chiller rests. This is strong evidence that modifying Kindman as modified as claimed would produce predictable results (i.e. reducing the overall footprint of the chiller). Accordingly, 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 Kindman as modified by Cowley and arrive at the claimed invention since all claimed elements were known in the art and one having ordinary skill in the art could have combined the elements as claimed by known methods with no changes in their respective functions and the combination would have yielded the predictable result of reducing the overall footprint of the chiller.
Allowable Subject Matter
Claim 20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Regarding claim 20 there is no current art of record which teaches storing both vials with radiation shielding and syringes with radiation shielding the same chiller and locking the syringes to the radiation shielding and to the casing, in combination with all other claimed features.
Claims 21-22 would also be allowable by virtue of their dependency on claim 20, see 112(d) rejections above.
Response to Arguments
Applicant's arguments filed May 07th, 2026 have been fully considered but they are not persuasive.
Applicant argues on Pg. 4 (as numbered by the Applicant) of the Remarks, “With regard to claim 1, the Examiner asserts that it would have been obvious to employ a plastic container having a metal bottom for facilitating heat transfer between an exterior and an interior of the plastic container. This is simply not the case. First, it should be noted that claim 1 has been amended to essentially incorporate the limitations of claim 3. In this amendment, the claim now recites that a plastic container has a metal bottom for facilitating heat transfer between an exterior and interior of the plastic container, and wherein the plastic container is comprised of a radiation attenuating material. Nothing in Kindman suggests that his device could be used or ever was intended to be used with radiation emitting materials. Therefore, there would be no motivation in Kindman for one to employ a plastic container that is comprised of radiation attenuating materials, since there is no radiation to attenuate in anything disclosed by Kindman. Additionally, there is no reason in Kindman to employ a metal bottom onto his vials. Rather, one reviewing Kindman would simply employ glass vials because of the heat transfer properties, which do not require the addition of a metal bottom.” However, this argument is not persuasive as the Kindman explicitly discloses the first vial receiver to have a metal bottom for facilitating heat transfer between an exterior and an interior of the container (Kindman, Col. 1, lines 20-30, a housing 12 which contains a heat conductive aluminum block 14 (see particularly FIGS. 2-4) defining four individual wells 14A therein. Wells 14A may be any suitable size to accommodate an optical cuvette, test tube, microcentrifuge tube or the like, and wells 14A in apparatus 10 are eighteen millimeter (mm) diameter holes which have been drilled into aluminum block 14. Thermoelectric elements 16 are secured to each of the four sides of aluminum block 14 so as to heat aluminum block 14 above ambient temperature or to cool aluminum block 14 below ambient temperature, as desired). Further, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use or purpose and therefore would have been obvious to a PHOSITA to modify the material of the first via receiver to be a radiation attenuating material if a PHOSITA intends to use the system of Kindman with radioactive material within the vials. Further, as evidenced by Reich (US Patent No. 5,519,931), hereinafter Reich, plastic materials with radiation attenuating properties are known materials in the art (Col. 7, lines 24-35, The upper and lower shields also can be constructed from a thermoplastic polycarbonate condensation product of bisphenol-A and phosgene, sold under the trademark Lexan by the General Electric Company, Polymers Products Department, Pittsfield, Mass. 01201. In a suitable thickness, the Lexan material blocks certain types of radiation to an acceptable extent as is known in the art. Furthermore, according to well known principles, the shields also can be constructed of depleted uranium, tungsten, Plexiglass® or other materials suitable for the radiation associated with a given application). See the rejection of claim 1 above.
Applicant argues on Pg. 5-6 (as numbered by the Applicant) of the Remarks, “The essence of the Examiner's rejection of claim 5 was through a combination of Kindman and Foster. The Applicants' invention differs significantly from Foster. Although Foster discloses the use of a syringe 12 that is received in a barrel or member 30, it is important to note that Foster's barrel member 30 is designed to accompany the syringe. In contrast, the applicant's claim 5 recites that the chiller casing includes the applicator receiver in thermal contact with the thermoelectric cooler for maintaining medical materials in the applicator below ambient temperature. There is no disclosure or suggestion in Kindman that his device would be capable of being used with radioactive materials, as it does not generally include shielding, or other means for attenuating radiation emitted by medical materials. Foster does not disclose or suggest that his device could be coupled to a thermocouple chiller, or that any applicator receiver is a part of a chiller casing as recited in the Applicants' claim 5. Additionally, Kindman and Foster cannot be combined to disclose or suggest the recited applicator shield that includes an annual or a groove configured to be engaged by the user's fingers for facilitating movement of the applicator shield and the applicator. No such shield is disclosed in Kindman, nor is there any vehicle in Foster for coupling shield to a casing.” However, this argument is not persuasive as claim 5 was, and still is, being rejected by Kindman in view of Norman, not in view of Foster. Further, the teachings of Norman show it is known in the art to use a chiller for temperature control of both vials and syringes (or applicators) (Norman, Pg. 4, paragraph 35, As shown in FIG. 7, flaps 88 are flexible and allow the insertion of variously sized objects, such as container 18 (FIG. 7), and/or feeding syringe 90 (FIG. 8) into collar 72c. It will be appreciated by those skilled in the art that collar 72c is most beneficially made from a flexible plastic or rubber, such as neoprene or polyethylene or polypropylene which is selected to provide a sufficient degree of flexibility so that variously sized objects may be supported within collar 72c by flaps 88. In this manner, variously sized devices may be supported by collar 72c, as well as oddly or asymmetrically shaped devices. It should further be appreciated that the materials for a construction of collar 72a and/or 72b may be less flexible than the most desirable materials used to construct collar 72c. By contrast, collar 72a and 72b do not require the degree of flexibility which is desirable for flaps 88 of collar 72c, rather, collars 72a, 72b may be of a more rigid nature as they are generally designed to accommodate the particular container size 18 being employed by the user of device 10) to provide a sufficient degree of flexibility so that variously sized objects may be supported the chiller (Norman, Pg. 4, paragraph 35). See the rejection of claim 5 above.
Applicant argues on Pg. 5-6 (as numbered by the Applicant) of the Remarks, “Claim 10, recites the existence of an applicator receiver that comprises at least one tubular passageway formed as a part of the casing and configured for receiving the applicator within the passageway. No tubular passageway that is formed as a part of the casing is disclosed or suggested in either Kindman or Foster. Claim 10 also recites that the medical materials comprise radiation emitting medical materials.” However, this argument is not persuasive since it has been held that forming in one piece an article that has formerly been formed in more than one piece and put together involves only routine skill in the art. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (A claim to a fluid transporting vehicle was rejected as obvious over a prior art reference which differed from the prior art in claiming a brake drum integral with a clamping means, whereas the brake disc and clamp of the prior art comprise several parts rigidly secured together as a single unit. The court affirmed the rejection holding, among other reasons, “that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice.”) MPEP 2144.04-V-B. Further, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the medical materials comprise radiation emitting medical materials) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). See the rejection of claim 10 above.
The rejections of independent claims 1, 5, and 10 are maintained. The rejections of dependent claims 2, 6-9, and 11-17 are also maintained for at least the reasons described herein.
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 DEVON T MOORE whose telephone number is 571-272-6555. The examiner can normally be reached M-F, 7:30-5.
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/DEVON MOORE/Examiner, Art Unit 3763 July 21st, 2026
/FRANTZ F JULES/Supervisory Patent Examiner, Art Unit 3763
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