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 .
Amendment Entered
In response to the amendment filed on February 25th, 2026, amended claims 5-13 and 21-30 are entered.
Response to Arguments
Applicant's remarks and amendments with respect to the claim objections have been fully considered. The objections are withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the claim interpretations under 35 U.S.C. 112(f) have been fully considered but they are not persuasive. The claim interpretations are maintained in view of the amendments.
At Pg. 8 of the Reply, Applicant argues that “Applicant has amended independent claims 5, 21, and 26 to explicitly recite the structural components of the refrigeration unit”. Examiner would like to clarify that Applicant has not amended independent claims 5, 21, and 26 to explicitly recite the structural components of the refrigeration unit. Although the Applicant has amended independent claims 5, 21, and 26, none of the amendments are related to the refrigeration unit. Applicant further argues “[s]pecifically, claims 11, 12, and 22, which depend from claims 5, 21, and 26 respectively, have been amended to further clarify that the refrigeration unit comprises one or more of an ice pack, a chemical ice pack, or dry ice, and that the refrigeration unit maintains the predetermined temperature range during shipping of the system from a manufacturing facility to a provider’s office. These amendments add sufficient structural language to clearly define the refrigeration unit and avoid any interpretation under 35 U.S.C. 112(f)”. Examiner would like to clarify that claims 12 and 22 had already previously recited “wherein the refrigeration unit comprises one or more of an ice pack, a chemical ice pack, and dry ice”. Therefore, claims 12 and 22 were purposely not included in the previous claim interpretations, as claims 12 and 22 recited sufficient structural language. However, regarding claim 11, although the Applicant has amended the claim to now recite “wherein the predetermined temperature range comprises a temperature in a range from 33 degrees to 46 degrees, and wherein the refrigeration unit maintains the predetermined temperature range during shipping of the immunotherapy mixing kit from a manufacturing facility to a provider's office”, claim 11 still fails to recite sufficient structural language to clearly define the refrigeration unit and avoid any interpretation under 35 U.S.C. 112(f).
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 112(b) have been fully considered. The rejections are withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 102 and 103 have been considered but are not fully persuasive. Although the 102 rejections of claims 5-10, 13, 21, and 23-25 have been withdrawn, the 102 rejections of claims 26-30 have been maintained. Furthermore, due to the withdrawn 102 rejections of independent claims 5 and 21, the previous 103 rejections of dependent claims 11, 12, and 22 have also been withdrawn. However, the arguments regarding the 103 rejections are not persuasive. Further clarification for each of the claims and rejections have been specified below.
At Pgs. 9-10 of the Reply, Applicant argues that amended claim 5 is not anticipated by Baker because “Baker’s housing is directed towards a stationary dispensing system, not a shipping container…Baker’s system is designed for the supply vessels to remain attached to the dispensing apparatus, not to be shipped as part of a portable kit from a first location to a second location”. Examiner respectfully disagrees. It seems that the Applicant is arguing more than what is actually being claimed. There is no current claim requirement that precludes a stationary dispensing system or attached supply vessels from fulfilling the current limitations. A stationary system, along with attached supply vessels, can still be shipped from one location or another. As claim 5 is not a method claim, the limitation “configured to…during shipping and handling from a first location to a second location” is a recitation of the intended use of the invention. The claimed “container having a plurality of compartments” is certainly capable of receiving and holding the one or more prefilled containers during shipping and handling from a first location to a second location. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations.
Further at Pg. 10 of the Reply, Applicant argues that Baker fails to disclose “one or more color coded vials”. The Applicant’s arguments are persuasive, and therefore, the rejections are withdrawn.
Examiner notes that the 102 rejection of claim 21 has been withdrawn for the same reasons discussed above regarding claim 5.
However, the 102 rejections of claims 26-30 have been maintained because there is no recitation of “color coded” vials present in independent claim 26. Regarding the new amendments, Examiner once again notes that claim 26 is not a method claim. Therefore, the limitation “configured to…during shipping and handling from a first location to a second location” is a recitation of the intended use of the invention. The claimed “container” is certainly capable of receiving and holding the one or more prefilled containers during shipping and handling from a first location to a second location. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations.
At Pgs. 11-12 of the Reply, Applicant argues that the combination of Baker and Jentis fails to teach or suggest the amended claim limitations. Examiner respectfully disagrees. Applicant argues that “Baker’s system is configured as a floor model…not a portable kit shipped from a manufacturing facility to a provider’s office”. Examiner would like to clarify that Jentis is remedying this deficiency of Baker. The temperature regulating means of Jentis would be used during transportation. Examiner once again notes that claim 11 is not a method claim. The limitation “maintains…during shipping of the immunotherapy mixing kit from a manufacturing facility to a provider's office” is a recitation of the intended use of the invention. The refrigeration means is certainly capable of maintaining the predetermined temperature range during shipping of the immunotherapy mixing kit from a manufacturing facility to a provider's office. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Applicant further argues that Jentis teaches “an insulin preserving traveling kit for diabetics, which relates to insulin preservation during travel by a diabetic patient, not to shipping an immunotherapy kit from a manufacturing facility to a provider’s office for mixing custom immunotherapy treatments”. Examiner respectfully disagrees. The purpose and result of the refrigeration would be the same, which would be maintaining biological solutions at their required temperatures to prevent degradation. Jentis clearly discloses that travel can impose serious problems to biological solutions (Jentis Column 1 Lines 14-29). Preventing degradation is a well-known rationale for modification of a medical device. Additionally, insulin is a known allergen for some patients; therefore, under that interpretation, the insulin could qualify as an allergen extract, which is a part of the current claim limitations.
At Pgs. 12-13 of the Reply, Applicant argues that the combination of Baker and Haines fails to teach or suggest the amended claim limitations. Examiner respectfully disagrees. Applicant argues that “Baker teaches a stationary system with active thermal control, not a portable kit with passive refrigeration for shipping purposes”. Examiner would like to clarify that Haines is remedying this deficiency of Baker. The dry ice of Haines would be used during transportation. Examiner once again notes that claims 12 and 22 are not method claims. The limitation “maintains…during shipping of the immunotherapy mixing kit from a manufacturing facility to a provider's office” is a recitation of the intended use of the invention. The dry ice of Haines is certainly capable of maintaining the predetermined temperature range during shipping of the immunotherapy mixing kit from a manufacturing facility to a provider's office. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Applicant further argues “[t]he dry ice in Haines serves an entirely different function—sample concentration for diagnostic analysis—in an entirely different context than maintaining allergen extracts at a predetermined temperature”. Examiner respectfully disagrees. The purpose and result of the “dry ice” would be the same, to keep biological contents cool without the need for a separate cooling system that may be subject to mechanical failure as well as providing a cooling system that can be easily transported, regardless of the context of what the biological contents actually are.
Claim Objections
Claims 13, 24, 26, 28, and 30 are objected to because of the following informalities:
Claim 13 recites “the container having a plurality of compartments” in lines 1-2, but should read “the container having the plurality of compartments”
Claim 24 recites “comprises one or more vials” in line 2, but should read “comprises the one or more vials”
Claim 26 recites “wherein one or more of the personalized allergen extracts” in line 4, but should read “wherein the one or more personalized allergen extracts”
Claim 28 recites “or one or more vials” in lines 2-3, but should read “or the one or more vials”
Claim 30 recites “the container having a plurality of compartments” in line 2, but should read “the container having the plurality of compartments”
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: “refrigeration unit” in Claims 5, 11, 21, and 26. The “refrigeration unit” is being interpreted as “an ice pack or other cooling device, e.g., dry ice, electric cooler, and the like…optionally and/or alternatively, other types of refrigeration units may be used, e.g., sleeves around each syringe, electronic, and combinations of the same” as recited in [0079] of the Applicant’s Specification.
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 5-13 and 21-25 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 5 recites “for seventy two hours or less” in line 12. The scope of the claim is unclear because the recitation of “seventy two hours or less” appears to include no refrigeration being required at all. Therefore, it is unclear as to whether the claims even require refrigeration.
Claim 21 recites “for seventy two hours or less” in line 8. The scope of the claim is unclear because the recitation of “seventy two hours or less” appears to include no refrigeration being required at all. Therefore, it is unclear as to whether the claims even require refrigeration.
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.
Claims 26-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baker et al (U.S. Publication No. 2009/0145509; previously cited).
Regarding Claim 26, Baker discloses an immunotherapy mixing kit for preparing and mixing a custom immunotherapy treatment for a patient (system for dispensing biological fluids, such as allergens; Abstract), comprising:
one or more prefilled containers (a plurality of supply (stock) vessels, such as vessels 88, 90, 92. Each stock vessel may include a biological fluid, such as fluids 94, 96, 98, generally in liquid form; [0057]) comprising one or more personalized allergen extracts (The biological fluids may be used for any suitable purpose…exemplary biologically active agents may include allergens, such as extracts (particularly protein extracts) from food, molds, animal dander, plants, pollens, dust mites, venoms, bacteria, and/or the like. In some examples, the biological fluids may include synthetic allergens; [0076]), wherein one or more of the personalized allergen extracts are determined by one or more of information indicative of an allergy test results, information indicative of a clinician's diagnosis, or information indicative of information received from a software program configured to programmatically deduce a patient-specific diagnosis (A single biological fluid or a mixture of biological fluids to be prepared may be identified or selected. In some examples, the mixture may be defined based on allergen sensitivity testing. Identification or selection of the mixture may identify or select a set of biological fluids to be included in the mixture and volumes/dilutions/concentrations for each fluid of the set (or for a single fluid). This step of identification or selection also may select a volume(s) of diluent(s) and/or excipient(s) to be included in the mixture (or to be combined with the single biological fluid). In some embodiments, the step of identification or selection may be performed by a controller of a dispensing system. For example, the controller may receive data corresponding to the types and volumes of fluids to be dispensed to create a mixture, such as through a user interface and/or other data transfer mechanism (a network, removable storage media, etc.). In some examples, the controller may determine a suitable mixture of allergens for a subject using an algorithm and test data (such as data from a skin or RAST test) from the subject; [0128]);
a container having a plurality of compartments configured to receive the one or more prefilled containers and hold the one or more prefilled containers during shipping and handling from a first location to a second location (Housing 82 may be configured to hold a plurality of supply (stock) vessels, such as vessels 88, 90, 92…The housing may be configured to protect the supply vessels and their biological fluids from ambient conditions, for example, by defining an interior compartment(s) that may be cooled, protected from light, etc. In some examples, the housing may be coupled movably to a base, so that the housing may reciprocate or turn, among others, on the base. This movement of the housing may permit a person dispensing the biological fluids to gain sequential access to, and/or to conveniently position, different dispensers/biological fluids; [0057]; Examiner’s Note: As claim 26 is not a method claim, the limitation “configured to…during shipping and handling from a first location to a second location” is a recitation of the intended use of the invention. The claimed “container having a plurality of compartments” is certainly capable of receiving and holding the one or more prefilled containers during shipping and handling from a first location to a second location. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations); and
a refrigeration unit configured to keep the one or more prefilled containers within a predetermined temperature range for at least twenty four hours (System 54 also may include a thermal control system 59 that regulates the temperature of the supply vessels and their fluid contents. For example, the thermal control system may cool (and/or heat) the supply vessels, shown at 60A, to the same and/or different temperatures. In some examples, the thermal control system may be configured to cool (refrigerate) the supply vessels and/or a compartment(s) in which the supply vessels are disposed, such that the biological fluids in the supply vessels are maintained at a temperature below the ambient temperature around the system. In some examples, the thermal control system also or alternatively may regulate, indicated at 60B, the temperature in a compartment around the dispensers; [0049]); and
one or more vials configured to be used to mix contents of the one or more prefilled containers (A single biological fluid or a mixture of biological fluids to be prepared may be identified or selected. In some examples, the mixture may be defined based on allergen sensitivity testing. Identification or selection of the mixture may identify or select a set of biological fluids to be included in the mixture and volumes/dilutions/concentrations for each fluid of the set (or for a single fluid). This step of identification or selection also may select a volume(s) of diluent(s) and/or excipient(s) to be included in the mixture (or to be combined with the single biological fluid); [0128]; Each dispenser station 186 may include a stock vial 208 holding an allergen stock 190 (or a vessel holding another fluid, such as a diluent, excipient, drug, etc.); [0141]).
Regarding Claim 27, Baker discloses wherein the one or more vials comprises a diluent (The biological fluids generally include any fluid—liquid and/or gas—at least partially derived from and/or affecting living organisms. The biological fluids may include any suitable ratios of biological extracts, synthetic compounds, microorganisms, organelles, excipients, diluents, buffers, salts, and/or the like; [0075]; A single biological fluid or a mixture of biological fluids to be prepared may be identified or selected. In some examples, the mixture may be defined based on allergen sensitivity testing. Identification or selection of the mixture may identify or select a set of biological fluids to be included in the mixture and volumes/dilutions/concentrations for each fluid of the set (or for a single fluid). This step of identification or selection also may select a volume(s) of diluent(s) and/or excipient(s) to be included in the mixture (or to be combined with the single biological fluid); [0128]; Each dispenser station 186 may include a stock vial 208 holding an allergen stock 190 (or a vessel holding another fluid, such as a diluent, excipient, drug, etc.); [0141]).
Regarding Claim 28, Baker discloses wherein the one or more prefilled containers comprises one or more of a cartridge (dispenser unit 210; [0142-0152]) or one or more vials (Each dispenser station 186 may include a stock vial 208 holding an allergen stock 190 (or a vessel holding another fluid, such as a diluent, excipient, drug, etc.); [0141]).
Regarding Claim 29, Baker discloses wherein the one or more prefilled containers comprises one or more prefilled syringes (syringe 284; [0151-0155]).
Regarding Claim 30, Baker discloses wherein the container having a plurality of compartments comprises one or more of a cardboard material, plastic material, thermoplastic material, paper material, or combinations thereof (A thermally insulating material may be disposed around the jacket structure in an insulator region 546 defined between the jacket structure and side walls 542. Exemplary thermally insulating materials that may be suitable include thermally insulating plastics (e.g., foam insulating plastics), nonplastics, and/or a combination thereof. Each jacket structure thus may be thermally isolated from other jacket structures disposed in the storage area, allowing individual thermal control of each jacket structure (and a set of supply vials disposed in each jacket structure). A central compartment 548 of the storage area may hold electrical conduits, electronic components of the system, and/or portions of the thermal control system, among others, and/or may remain at least substantially empty; [0172]; The peltier device and at least a lower portion of the sink block may be surrounded laterally by a thermally insulating material, to restrict heat flow from the sink block back to the jacket structure, lateral to the peltier device…insulation may be provided by upper plate 536 (see FIGS. 19 and 20) formed of a thermally insulating material, such as polyethylene; [0179]).
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.
Claims 5-10, 13, 21, and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Baker et al in view of Strader et al (U.S. Publication No. 2017/0224267).
Regarding Claim 5, Baker discloses an immunotherapy mixing kit for preparing and mixing a custom immunotherapy treatment for a patient (system for dispensing biological fluids, such as allergens; Abstract), comprising:
one or more prefilled containers (a plurality of supply (stock) vessels, such as vessels 88, 90, 92. Each stock vessel may include a biological fluid, such as fluids 94, 96, 98, generally in liquid form; [0057]) comprising an allergen extract (The biological fluids may be used for any suitable purpose…exemplary biologically active agents may include allergens, such as extracts (particularly protein extracts) from food, molds, animal dander, plants, pollens, dust mites, venoms, bacteria, and/or the like. In some examples, the biological fluids may include synthetic allergens; [0076]), wherein the allergen extract is personalized to the patient and determined by information indicative of one or more allergy tests, information indicative of a diagnosis from a clinician and information indicative of a software program configured to programmatically deduce a patient-specific diagnosis (A single biological fluid or a mixture of biological fluids to be prepared may be identified or selected. In some examples, the mixture may be defined based on allergen sensitivity testing. Identification or selection of the mixture may identify or select a set of biological fluids to be included in the mixture and volumes/dilutions/concentrations for each fluid of the set (or for a single fluid). This step of identification or selection also may select a volume(s) of diluent(s) and/or excipient(s) to be included in the mixture (or to be combined with the single biological fluid). In some embodiments, the step of identification or selection may be performed by a controller of a dispensing system. For example, the controller may receive data corresponding to the types and volumes of fluids to be dispensed to create a mixture, such as through a user interface and/or other data transfer mechanism (a network, removable storage media, etc.). In some examples, the controller may determine a suitable mixture of allergens for a subject using an algorithm and test data (such as data from a skin or RAST test) from the subject; [0128]);
a container having a plurality of compartments configured to receive the one or more prefilled containers and hold the one or more prefilled containers during shipping and handling from a first location to a second location (Housing 82 may be configured to hold a plurality of supply (stock) vessels, such as vessels 88, 90, 92… The housing may be configured to protect the supply vessels and their biological fluids from ambient conditions, for example, by defining an interior compartment(s) that may be cooled, protected from light, etc. In some examples, the housing may be coupled movably to a base, so that the housing may reciprocate or turn, among others, on the base. This movement of the housing may permit a person dispensing the biological fluids to gain sequential access to, and/or to conveniently position, different dispensers/biological fluids; [0057]; Examiner’s
Note: As claim 5 is not a method claim, the limitation “configured to…during shipping and handling from a first location to a second location” is a recitation of the intended use of the invention. The claimed “container having a plurality of compartments” is certainly capable of receiving and holding the one or more prefilled containers during shipping and handling from a first location to a second location. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations), and
a refrigeration unit configured to keep the one or more prefilled containers within a predetermined temperature range for seventy two hours or less (System 54 also may include a thermal control system 59 that regulates the temperature of the supply vessels and their fluid contents. For example, the thermal control system may cool (and/or heat) the supply vessels, shown at 60A, to the same and/or different temperatures. In some examples, the thermal control system may be configured to cool (refrigerate) the supply vessels and/or a compartment(s) in which the supply vessels are disposed, such that the biological fluids in the supply vessels are maintained at a temperature below the ambient temperature around the system. In some examples, the thermal control system also or alternatively may regulate, indicated at 60B, the temperature in a compartment around the dispensers; [0049]); and
one or more vials configured to be used to mix contents of the one or more prefilled containers (A single biological fluid or a mixture of biological fluids to be prepared may be identified or selected. In some examples, the mixture may be defined based on allergen sensitivity testing. Identification or selection of the mixture may identify or select a set of biological fluids to be included in the mixture and volumes/dilutions/concentrations for each fluid of the set (or for a single fluid). This step of identification or selection also may select a volume(s) of diluent(s) and/or excipient(s) to be included in the mixture (or to be combined with the single biological fluid); [0128]; Each dispenser station 186 may include a stock vial 208 holding an allergen stock 190 (or a vessel holding another fluid, such as a diluent, excipient, drug, etc.); [0141]).
Although Baker teaches color coordination for the overall housing (The dispenser housing, another portion of the dispenser station, and/or the associated system housing may include indicia that identifies the biological fluid dispensed by the dispenser station. The indicia may include one or more alphanumeric characters (such as letters, words, and/or numbers), symbols, pictures, a color code, a bar code, an electronic code (such as data on a readable electronic chip (e.g., a Radiofrequency Identification (RFID) tag), and/or the like. These indicia may be used to verify and/or track the type of material (biological material) associated with the dispenser, before and/or after dispensing. In some cases, the indicia may be removable (such as one or more preprinted or custom printed stickers) and/or scannable/readable (such as by an optical or radiofrequency reader) to facilitate compiling a record of dispensed materials; [0103]), Baker fails to specifically teach one or more color coded vials configured to be used to mix contents of the one or more prefilled containers.
In a similar technical field, Strader teaches a prick test single use sterile vial and method (Abstract), comprising: one or more color coded vials configured to be used to mix contents of the one or more prefilled containers (Once it is determined which antigens elicit a response, a cocktail can then be created. This cocktail of antigens is facilitated by selecting the first bottle 1806 from section 1802. As noted in FIG. 18, each of the bottles 1806 is disposed within a well 1820…a finite amount of dilutant is extracted from the bottle 1806 labeled D1 and transferred to the second bottle 1806 labeled D2 and so on until the last transfer to the bottle 1806 labeled D6. This will be a final bottle. These bottles could also be color-coded or marked with the particular dilutant level such that they could be placed back into the kit; [0090]; Figure 20). Strader also teaches a container having a plurality of compartments configured to receive the one or more prefilled containers and hold the one or more prefilled containers during shipping and handling from a first location to a second location (Turning to FIG. 28, after labeling, vials 2410 are packaged. In one embodiment, vials 2410 are mechanically or manually inserted into a plastic strip or tray 2424. Vials 2410 packaged in tray 2424 may then be boxed or placed in an appropriate container for transport…given that FIG. 10 illustrates a prick tester having wells instead of recesses for holding bottles, other prick tester configurations may be used such as those shown in U.S. patent application Ser. No. 15/222,709, published as U.S. Patent Application Publication No. 2017/0027494, which U.S. patent application Ser. No. 15/222,709 and U.S. Patent Application Publication No. 2017/0027494 are herein incorporated by reference in their entirety. This prick testing kits hold vials in recesses arranged so that needles on a surface of the prick tester may be inserted into each vial and then applied to the skin of a patient. The prick testing kit may be assembled as one complete product, with the tray for the vials and the prick tester having the plurality of needles packaged together; [0103]).
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to have incorporated the color coding teachings of Strader into the invention of Baker in order to provide the system with a clear identification process for the medical professional when using the kit, as it is important that there be some indicia provided that will allow the antigen contents of the bottle to be discriminated from the contents of the other bottles with different antigens disposed therein (Strader [0076], [0079], [0090]).
Regarding Claim 6, Baker discloses wherein the one or more prefilled containers comprises five prefilled syringes (syringe 284; [0151-0155]).
Regarding Claim 7, Baker discloses wherein each of the five prefilled syringes further comprises a removable luer-lock on an end of each of the prefilled syringes (the syringe may be connected to the housing by, for example, a threaded and/or a Luer-Lok coupling; [0153]).
Regarding Claim 8, Baker discloses wherein each of the five prefilled syringes comprises a 1 cc syringe (The syringe pumps may have any suitable barrel capacity, such as a capacity of about 0.1 to 10 milliliters, among others. In some examples, a dispensing system may include syringes of different capacities coupled to different dispensers, such as smaller capacity syringes for dispensing allergens and larger capacity syringes for dispensing excipients/diluents. In exemplary embodiments, some or all of the syringe pumps may have a capacity of about one milliliter; [0091]).
Regarding Claim 9, Baker discloses wherein each of the five prefilled syringes further comprises a label having information indicative of one or more of a patient identifier, an allergen extract identifier, or a lot identifier (The dispenser housing, another portion of the dispenser station, and/or the associated system housing may include indicia that identifies the biological fluid dispensed by the dispenser station. The indicia may include one or more alphanumeric characters (such as letters, words, and/or numbers), symbols, pictures, a color code, a bar code, an electronic code (such as data on a readable electronic chip (e.g., a Radiofrequency Identification (RFID) tag), and/or the like. These indicia may be used to verify and/or track the type of material (biological material) associated with the dispenser, before and/or after dispensing. In some cases, the indicia may be removable (such as one or more preprinted or custom printed stickers) and/or scannable/readable (such as by an optical or radiofrequency reader) to facilitate compiling a record of dispensed materials; [0103]; The reader interface may provide communication with any suitable type of reader, such as an optical reader (e.g., a barcode scanner), a radiofrequency reader (e.g., a Radiofrequency IDentification (RFID) tag reader), and/or the like. The reader interface may be suitable, for example, to identify and track a receiver vessel (with a barcode or RFID tag) before, during, and/or after dispensing to the receiver vessel, to input data about a supply vessel, to track inventory, to record lot numbers, and/or the like; [0122]).
Regarding Claim 10, Baker discloses wherein each of the five prefilled syringes further comprises one or more of a computer code, a bar code, or a RFID tag having information indicative of one or more of a patient identifier, an antigen extract identifier, or a lot identifier (The dispenser housing, another portion of the dispenser station, and/or the associated system housing may include indicia that identifies the biological fluid dispensed by the dispenser station. The indicia may include one or more alphanumeric characters (such as letters, words, and/or numbers), symbols, pictures, a color code, a bar code, an electronic code (such as data on a readable electronic chip (e.g., a Radiofrequency Identification (RFID) tag), and/or the like. These indicia may be used to verify and/or track the type of material (biological material) associated with the dispenser, before and/or after dispensing. In some cases, the indicia may be removable (such as one or more preprinted or custom printed stickers) and/or scannable/readable (such as by an optical or radiofrequency reader) to facilitate compiling a record of dispensed materials; [0103]; The reader interface may provide communication with any suitable type of reader, such as an optical reader (e.g., a barcode scanner), a radiofrequency reader (e.g., a Radiofrequency IDentification (RFID) tag reader), and/or the like. The reader interface may be suitable, for example, to identify and track a receiver vessel (with a barcode or RFID tag) before, during, and/or after dispensing to the receiver vessel, to input data about a supply vessel, to track inventory, to record lot numbers, and/or the like; [0122]).
Regarding Claim 13, Baker discloses wherein the container having a plurality of compartments comprises a thermoform comprising a thermoplastic material (A thermally insulating material may be disposed around the jacket structure in an insulator region 546 defined between the jacket structure and side walls 542. Exemplary thermally insulating materials that may be suitable include thermally insulating plastics (e.g., foam insulating plastics), nonplastics, and/or a combination thereof. Each jacket structure thus may be thermally isolated from other jacket structures disposed in the storage area, allowing individual thermal control of each jacket structure (and a set of supply vials disposed in each jacket structure). A central compartment 548 of the storage area may hold electrical conduits, electronic components of the system, and/or portions of the thermal control system, among others, and/or may remain at least substantially empty; [0172]; The peltier device and at least a lower portion of the sink block may be surrounded laterally by a thermally insulating material, to restrict heat flow from the sink block back to the jacket structure, lateral to the peltier device…insulation may be provided by upper plate 536 (see FIGS. 19 and 20) formed of a thermally insulating material, such as polyethylene; [0179]).
Regarding Claim 21, Baker discloses an immunotherapy kit for preparing an immunotherapy treatment for a patient (system for dispensing biological fluids, such as allergens; Abstract), comprising:
one or more prefilled containers (a plurality of supply (stock) vessels, such as vessels 88, 90, 92. Each stock vessel may include a biological fluid, such as fluids 94, 96, 98, generally in liquid form; [0057]) comprising one or more allergen extracts (The biological fluids may be used for any suitable purpose…exemplary biologically active agents may include allergens, such as extracts (particularly protein extracts) from food, molds, animal dander, plants, pollens, dust mites, venoms, bacteria, and/or the like. In some examples, the biological fluids may include synthetic allergens; [0076]);
a container configured to receive the one or more prefilled containers and holding the one or more prefilled containers during shipping and handling from a first location to a second location (Housing 82 may be configured to hold a plurality of supply (stock) vessels, such as vessels 88, 90, 92… The housing may be configured to protect the supply vessels and their biological fluids from ambient conditions, for example, by defining an interior compartment(s) that may be cooled, protected from light, etc. In some examples, the housing may be coupled movably to a base, so that the housing may reciprocate or turn, among others, on the base. This movement of the housing may permit a person dispensing the biological fluids to gain sequential access to, and/or to conveniently position, different dispensers/biological fluids; [0057]; Examiner’s Note: As claim 21 is not a method claim, the limitation “configured to…during shipping and handling from a first location to a second location” is a recitation of the intended use of the invention. The claimed “container” is certainly capable of receiving and holding the one or more prefilled containers during shipping and handling from a first location to a second location. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations); and
a refrigeration unit configured to keep the one or more prefilled containers within a predetermined temperature range for seventy two hours or less (system 54 also may include a thermal control system 59 that regulates the temperature of the supply vessels and their fluid contents. For example, the thermal control system may cool (and/or heat) the supply vessels, shown at 60A, to the same and/or different temperatures. In some examples, the thermal control system may be configured to cool (refrigerate) the supply vessels and/or a compartment(s) in which the supply vessels are disposed, such that the biological fluids in the supply vessels are maintained at a temperature below the ambient temperature around the system. In some examples, the thermal control system also or alternatively may regulate, indicated at 60B, the temperature in a compartment around the dispensers; [0049]); and
one or more vials used (A single biological fluid or a mixture of biological fluids to be prepared may be identified or selected. In some examples, the mixture may be defined based on allergen sensitivity testing. Identification or selection of the mixture may identify or select a set of biological fluids to be included in the mixture and volumes/dilutions/concentrations for each fluid of the set (or for a single fluid). This step of identification or selection also may select a volume(s) of diluent(s) and/or excipient(s) to be included in the mixture (or to be combined with the single biological fluid); [0128]; Each dispenser station 186 may include a stock vial 208 holding an allergen stock 190 (or a vessel holding another fluid, such as a diluent, excipient, drug, etc.); [0141]).
Although Baker teaches color coordination for the overall housing (The dispenser housing, another portion of the dispenser station, and/or the associated system housing may include indicia that identifies the biological fluid dispensed by the dispenser station. The indicia may include one or more alphanumeric characters (such as letters, words, and/or numbers), symbols, pictures, a color code, a bar code, an electronic code (such as data on a readable electronic chip (e.g., a Radiofrequency Identification (RFID) tag), and/or the like. These indicia may be used to verify and/or track the type of material (biological material) associated with the dispenser, before and/or after dispensing. In some cases, the indicia may be removable (such as one or more preprinted or custom printed stickers) and/or scannable/readable (such as by an optical or radiofrequency reader) to facilitate compiling a record of dispensed materials; [0103]), Baker fails to specifically teach one or more color coded vials used.
In a similar technical field, Strader teaches a prick test single use sterile vial and method (Abstract), comprising: one or more color coded vials used (Once it is determined which antigens elicit a response, a cocktail can then be created. This cocktail of antigens is facilitated by selecting the first bottle 1806 from section 1802. As noted in FIG. 18, each of the bottles 1806 is disposed within a well 1820… A finite amount of dilutant is extracted from the bottle 1806 labeled D1 and transferred to the second bottle 1806 labeled D2 and so on until the last transfer to the bottle 1806 labeled D6. This will be a final bottle. These bottles could also be color-coded or marked with the particular dilutant level such that they could be placed back into the kit; [0090]; Figure 20). Strader also teaches a container configured to receive the one or more prefilled containers and holding the one or more prefilled containers during shipping and handling from a first location to a second location (Turning to FIG. 28, after labeling, vials 2410 are packaged. In one embodiment, vials 2410 are mechanically or manually inserted into a plastic strip or tray 2424. Vials 2410 packaged in tray 2424 may then be boxed or placed in an appropriate container for transport…given that FIG. 10 illustrates a prick tester having wells instead of recesses for holding bottles, other prick tester configurations may be used such as those shown in U.S. patent application Ser. No. 15/222,709, published as U.S. Patent Application Publication No. 2017/0027494, which U.S. patent application Ser. No. 15/222,709 and U.S. Patent Application Publication No. 2017/0027494 are herein incorporated by reference in their entirety. This prick testing kits hold vials in recesses arranged so that needles on a surface of the prick tester may be inserted into each vial and then applied to the skin of a patient. The prick testing kit may be assembled as one complete product, with the tray for the vials and the prick tester having the plurality of needles packaged together; [0103]).
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to have incorporated the color coding teachings of Strader into the invention of Baker in order to provide the system with a clear identification process for the medical professional when using the kit, as it is important that there be some indicia provided that will allow the antigen contents of the bottle to be discriminated from the contents of the other bottles with different antigens disposed therein (Strader [0076], [0079], [0090]).
Regarding Claim 23, Baker discloses wherein the one or more prefilled containers comprises one or more prefilled syringes (syringe 284; [0151-0155]).
Regarding Claim 24, Baker discloses wherein the one or more prefilled containers comprises one or more vials (Each dispenser station 186 may include a stock vial 208 holding an allergen stock 190 (or a vessel holding another fluid, such as a diluent, excipient, drug, etc.); [0141]).
Regarding Claim 25, Baker discloses wherein the one or more prefilled containers comprises one or more cartridges (dispenser unit 210; [0142-0152]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Baker and Strader as applied to claim 5 above, and further in view of Jentis et al (U.S. Patent No. 3,148,515; previously cited).
Regarding Claim 11, although Baker discloses a refrigeration unit configured to keep the one or more prefilled containers within a predetermined temperature range for seventy two hours or less (System 54 also may include a thermal control system 59 that regulates the temperature of the supply vessels and their fluid contents. For example, the thermal control system may cool (and/or heat) the supply vessels, shown at 60A, to the same and/or different temperatures. In some examples, the thermal control system may be configured to cool (refrigerate) the supply vessels and/or a compartment(s) in which the supply vessels are disposed, such that the biological fluids in the supply vessels are maintained at a temperature below the ambient temperature around the system. In some examples, the thermal control system also or alternatively may regulate, indicated at 60B, the temperature in a compartment around the dispensers; [0049]), Baker and Strader fail to specifically teach wherein the predetermined temperature range comprises a temperature in a range from 33 degrees to 46 degrees, and wherein the refrigeration unit maintains the predetermined temperature range during shipping of the immunotherapy mixing kit from a manufacturing facility to a provider's office.
In a similar technical field, Jentis teaches an insulin preserving travel kit for diabetics (Abstract), wherein the predetermined temperature range comprises a temperature in a range from about 33 degrees to about 46 degrees (The refrigeration means will maintain the temperature of the insulin at a safe degree of 40 F. for at least twenty-four hours; Column 6 Lines 44-46), and wherein the refrigeration unit maintains the predetermined temperature range during shipping of the immunotherapy mixing kit from a manufacturing facility to a provider's office (A miniature insulin refrigeration unit 22 is located in compartments 11 and 14; Column 2 Lines 65-66; Thermostatic regulating means for movable throttle valve 35 is shown in FIG. 5…thereupon, when the temperature has been restored to the required safe degree of 40 F., bimetallic element 53 will return to its straight inoperative position and allow movable valve member 35 again to close on its seat and check the flow of liquid Freon; Column 4 Lines 20-43; Examiner’s Note: As Claim 11 is not a method claim, the limitation “maintains…during shipping of the immunotherapy mixing kit from a manufacturing facility to a provider's office” is a recitation of the intended use of the invention. Jentis teaches a portable kit with a refrigeration unit, which is certainly capable of maintaining the predetermined temperature range during shipping of the immunotherapy mixing kit from a manufacturing facility to a provider's office. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations).
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to have incorporated the temperature regulating means teachings of Jentis into those of Baker and Strader, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.II. The Examiner notes that a particular parameter must be recognized as a result effective variable, in this case, that parameter is temperature which achieves the recognized result of maintaining biological solutions at their required temperatures to prevent degradation (It is well known that persons afflicted with certain types of diabetes require hypodermic injections of insulin at regular intervals. Moreover, insulin must be preserved for safe administration at a temperature of approximately 40 Fahrenheit. At home, it is practicable for the patient to keep his supply of insulin in the kitchen refrigerator at the required temperature, but travel imposes a serious problem in this respect. It, therefore, is the primary object of our invention to provide an insulin travel kit which incorporates in a lightweight carrying case means to hold a bottle of insulin and the dose administration accessory equipment, such as a hypodermic syringe, spare hypodermic needles, a bottle of alcohol, and a cotton dispensing container, together with means to maintain the insulin supply at the required safe temperature for at least twenty-four hours; Jentis Column 1 Lines 14-29); therefore, one of ordinary skill in the art at the filing date of the invention would have found the claimed range through routine experimentation.
Claims 12 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Baker and Strader as applied to claims 5 and 21 above, and further in view of Haines et al (U.S. Publication No. 2011/0105856; previously cited).
Regarding Claim 12, although Baker discloses a refrigeration unit configured to keep the one or more prefilled containers within a predetermined temperature range for seventy two hours or less (System 54 also may include a thermal control system 59 that regulates the temperature of the supply vessels and their fluid contents. For example, the thermal control system may cool (and/or heat) the supply vessels, shown at 60A, to the same and/or different temperatures. In some examples, the thermal control system may be configured to cool (refrigerate) the supply vessels and/or a compartment(s) in which the supply vessels are disposed, such that the biological fluids in the supply vessels are maintained at a temperature below the ambient temperature around the system. In some examples, the thermal control system also or alternatively may regulate, indicated at 60B, the temperature in a compartment around the dispensers; [0049]), Baker and Strader fail to specifically teach wherein the refrigeration unit comprises one or more of an ice pack, a chemical ice pack, or dry ice, and wherein the refrigeration unit maintains the predetermined temperature range during shipping of the immunotherapy mixing kit from a manufacturing facility to a provider's office.
In a similar technical field, Haines teaches methods for evaluating for health conditions by taking samples (Abstract), wherein the refrigeration unit comprises one or more of an ice pack, a chemical ice pack, or dry ice (A health care method comprises collecting volatile samples from the breath, urine, feces, and/or skin of an individual, concentrating the samples by collecting them in a cold trap using dry ice; [0184]), and wherein the refrigeration unit maintains the predetermined temperature range during shipping of the immunotherapy mixing kit from a manufacturing facility to a provider's office (Examiner’s Note: As Claim 12 is not a method claim, the limitation “maintains…during shipping of the immunotherapy mixing kit from a manufacturing facility to a provider's office” is a recitation of the intended use of the invention. The “dry ice” is certainly capable of maintaining the predetermined temperature range during shipping of the immunotherapy mixing kit from a manufacturing facility to a provider's office. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations).
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to have incorporated the dry ice teachings of Haines into those of Baker and Strader in order to provide the system with a way to keep the contents cool without the need for a separate cooling system that may be subject to mechanical failure as well as providing a cooling system that can be easily transported.
Regarding Claim 22, although Baker discloses a refrigeration unit configured to keep the one or more prefilled containers within a predetermined temperature range for seventy two hours or less (System 54 also may include a thermal control system 59 that regulates the temperature of the supply vessels and their fluid contents. For example, the thermal control system may cool (and/or heat) the supply vessels, shown at 60A, to the same and/or different temperatures. In some examples, the thermal control system may be configured to cool (refrigerate) the supply vessels and/or a compartment(s) in which the supply vessels are disposed, such that the biological fluids in the supply vessels are maintained at a temperature below the ambient temperature around the system. In some examples, the thermal control system also or alternatively may regulate, indicated at 60B, the temperature in a compartment around the dispensers; [0049]), Baker and Strader fail to specifically teach wherein the refrigeration unit comprises one or more of an ice pack, a chemical ice pack, or dry ice, and wherein the refrigeration unit maintains the predetermined temperature range during shipping of the immunotherapy mixing kit from a manufacturing facility to a provider's office.
In a similar technical field, Haines teaches methods for evaluating for health conditions by taking samples (Abstract), wherein the refrigeration unit comprises one or more of an ice pack, a chemical ice pack, or dry ice (A health care method comprises collecting volatile samples from the breath, urine, feces, and/or skin of an individual, concentrating the samples by collecting them in a cold trap using dry ice; [0184]), and wherein the refrigeration unit maintains the predetermined temperature range during shipping of the immunotherapy mixing kit from a manufacturing facility to a provider's office (Examiner’s Note: As Claim 22 is not a method claim, the limitation “maintains…during shipping of the immunotherapy mixing kit from a manufacturing facility to a provider's office” is a recitation of the intended use of the invention. The “dry ice” is certainly capable of maintaining the predetermined temperature range during shipping of the immunotherapy mixing kit from a manufacturing facility to a provider's office. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations).
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to have incorporated the dry ice teachings of Haines into those of Baker and Strader in order to provide the system with a way to keep the contents cool without the need for a separate cooling system that may be subject to mechanical failure as well as providing a cooling system that can be easily transported.
Conclusion
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/CHANEL J YOON/Examiner, Art Unit 3791