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 .
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-17, drawn to a chiller for maintaining medical materials at a temperature below ambient room temperature, classified in A61J 1/165.
II. Claims 18-19, drawn to a container for encasing a vial containing a radioactive material, classified in G21F 5/00.
The inventions are independent or distinct, each from the other because:
Inventions I and II are directed to related products. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed can have a different mode of operation, function, or effect as the container of Invention II can be used without temperature control. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
the inventions require a different field of search (e.g., searching different classes/subclasses or
electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Victor Indiano on September 16th, 2025 a provisional election was made without traverse to prosecute the invention of Group 1, claims 1-17. Affirmation of this election must be made by applicant in replying to this Office action. Claims 18-19 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 2-4 and 15-17 are objected to because of the following informalities:
Claim 2, line 1: “the first and second vials” should read “the first vial and the second vial”
Claim 4, line 2: “the first and second vials” should read “the first vial and the second vial”
Claim 15, line 4: “the heat sinks” should read “the heat sink”
Claims 3-4 are also objected to by virtue of their dependency on claim 2.
Claim 16 is also objected to by virtue of its dependency on claim 15.
Claim 17 is also objected to by virtue of its dependency on claim 16.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 7, line 1: “locking mechanism” draws corresponding structure to the following recitation of the present disclosure, “As is best illustrated in Fig. 26, the thumb screw locking mechanism 210 includes a threaded rod 319 which extends through a threaded aperture 244 located in the outer wall 336 (Pg. 11, paragraph 96)”, or equivalents.
Claim 11, line 2: “applicator locking mechanism” draws corresponding structure to the following recitation of the present disclosure, “As is best illustrated in Fig. 26, the thumb screw locking mechanism 210 includes a threaded rod 319 which extends through a threaded aperture 244 located in the outer wall 336 (Pg. 11, paragraph 96)”, or equivalents.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 8, and 11-13 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 3 recites the limitation "the container" in line 2 and 3. There is insufficient antecedent basis for this limitation in the claim. The Examiner recommends changing “the container” in lines 2 and 3 of claim 3 to “the plastic container” which is given proper antecedent basis in line 1 of claim 3. For purposes of examination, the Examiner will interpret the container and the plastic container of claim 3 to be the same components.
Claim 8 recites the limitation "the locking mechanism" in line 1. There is insufficient antecedent basis for this limitation in the claim. The Examiner recommends either changing “the locking mechanism” in line 1 of claim 8 to “a locking mechanism” or changing the dependency of claim 8 to depend from claim 7 which provides proper antecedent basis for the locking mechanism.
Claim 11 recites the limitation "the applicator radiation shield" in line 3. There is insufficient antecedent basis for this limitation in the claim. The Examiner recommends changing “the applicator radiation shield” in line 3 of claim 11 to “the applicator receiving radiation shield” which is given proper antecedent basis in line 1 of claim 11. For purposes of examination, the Examiner will interpret the applicator radiation shield and the applicator receiving radiation shield to be the same components.
Claim 11 recites the limitation "the radiation shield" in line 4. There is insufficient antecedent basis for this limitation in the claim. The Examiner recommends changing “the radiation shield” in line 3 of claim 11 to “the applicator receiving radiation shield” which is given proper antecedent basis in line 1 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.
Claim 12 recites the limitation "the locking mechanism" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. The Examiner recommends changing “the locking mechanism” in lines 1-2 of claim 12 to “the applicator locking mechanism” which is given proper antecedent basis in claim 11 from which claim 12 depends. For purposes of examination, the Examiner will interpret the locking mechanism and the applicator locking mechanism to be the same components.
Claim 12 recites the limitation "the applicator radiation shield" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. The Examiner recommends changing “the applicator radiation shield” in lines 2-3 of claim 12 to “the applicator receiving radiation shield” which is given proper antecedent basis in claim 11 from which claim 12 depends. For purposes of examination, the Examiner will interpret the applicator radiation shield and the applicator receiving radiation shield to be the same components.
Claim 13 recites the limitation "the support member" in line 2-3. There is insufficient antecedent basis for this limitation in the claim. The Examiner recommends changing “the support member” to “the thermally conductive support member” which is given proper antecedent basis in lines 1-2 of claim 13. For purposes of examination, the Examiner will interpret the support member and the thermally conductive support member to be the same components.
Claim 13, lines 3-4, 5, and 6 recite, “tubular shaped applicators” which is unclear to the Examiner as to how the tubular shaped applicators of lines 3-4, 5, and 6 of claim 13 relate to the previously claimed applicator of claim 10 from which claim 13 depends. For purposes of examination, the Examiner will interpret the tubular shaped applicators and the applicator to be the same components. The Examiner recommends amending the claims to use consistent terminology when referring to 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 12 is also rejected by virtue of its dependency on claim 11.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4, and 15-17 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by 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); 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).
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Annotated Fig. 2 of Kindman
Regarding claim 2, Kindman discloses the chiller of claim 1 (see the rejection of claim 1 above)
wherein the first and second vials are configured for shipping and/or storage of the medical material (Fig. 1, vessels V; Col. 1, lines 51-59, 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; Further, the vessels V of Kindman have the same structure as the claimed first and second vials and are capable of functioning in the manner claimed).
Regarding claim 4, Kindman discloses the chiller of claim 1 (see the rejection of claim 1 above)
wherein the first vial comprises at least two first vials, and wherein the stirrer is configured for stirring medical materials in the first and second vials (Fig. 1, vessels V; 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; Further, the coils 50 and magnetic stirrer S of Kindman have the same structure as the claimed stirrer and are capable of functioning in the manner claimed).
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 sinks (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 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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kindman et al. (5,529,391), hereinafter Kindman.
Regarding claim 3, Kindman discloses the chiller of claim 2 (see the rejection of claim 2 above)
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).
However, Kindman does not disclose wherein the first vial receiver comprises a plastic container having a metal bottom and wherein the 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 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 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.
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 the chiller of claim 2 (see the rejection of claim 2 above).
However, Kindman does not disclose 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.
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 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 1 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 the chiller of claim 1 (see the rejection of claim 1 above).
However, Kindman does not disclose 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.
Norman teaches a chiller that can be used to cool both vials and applicators further comprising an applicator receiver and an applicator configured for applying medical materials to a patient (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),
the applicator receiver comprising at least one tubular passageway configured for receiving the applicator within the passageway (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 1 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).
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 locking mechanism engageable with the applicator and applicator receiver for fixedly positioning the applicator in the applicator receiver.
Yazbeck teaches a locking mechanism engageable with the applicator and 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).
Kindman as modified fails to teach a locking mechanism engageable with the applicator and applicator receiver for fixedly positioning the applicator in the applicator receiver, however Yazbeck teaches that it is a known method in the art of applicators to include a locking mechanism engageable with the applicator and applicator receiver for fixedly positioning the applicator in the applicator receive. 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 combin