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 .
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.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “wherein the insulated stopper further comprises a sub-plug centered on the vertical axis of the container with a diameter approximately equal to the payload cavity, wherein at least one of: the primary PCM pack and the secondary PCM pack are permanently bonded to each other; or the secondary PCM pack is permanently bonded to an insulated stopper” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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, 6, 9 and 14 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.
Regarding claim 3, the claim recites “the first portion comprising a first type of PCM, the second portion comprising a second type of PCM different from the first type of PCM”. However, it has been held that the addition of the word "type" to an otherwise definite expression
extends the scope of the expression so as to render it indefinite (See MPEP § 2173.05(b) (III)
(E)). It is unclear whether infringement would occur when the any phase change material is used, or if the claim requires a specific type of phase change material for infringement. For examination purposes, the claim will be construed as simply having a phase change material.
The term “substantially and approximately” in claims 6 and 9 is a relative term which renders the claim indefinite. The term “substantially and approximately” 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.
Claim 14 recites the limitation "an insulated stopper" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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 1 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shindler et al (US 5405012 A, herein after referred to as Shindler).
Regarding claim 1, Shindler teaches a temperature-controlled packaging system (figure 1) for biological samples (abstract), the system comprising a container (container 1) and a PCM pack (temperature regulating means 10) (i) form-fit to the container (figure 7) and (ii) defining a payload cavity for a biological sample (sockets 14-16, figure 2).
Regarding claim 8, Shindler teaches wherein the payload cavity (socket 15, figure 2) is centered on a vertical axis of the container (as shown on figure 5).
Claim 16 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olson et al (US 12050052 B1, herein after referred to as Olson).
Regarding claim 16, Olson teaches a method of shipping (during transportation, abstract) a biological sample (biological samples, abstract) comprising providing a vacuum shipper (the internal voids can be evacuated (e.g., under vacuum) to enhance the thermal insulating properties, col 9 lines 46-48), positioning a pre-conditioned cylindrical PCM pack (PCM 1804) into the vacuum shipper (container 1700), and placing a temperature-sensitive payload (a refrigerated carrier device that can maintain biological samples including capillary blood samples at refrigerated temperatures, abstract) in a payload cavity (storage compartment 1754) defined by the PCM pack (as shown on figure 2).
Regarding claim 19, Olson teaches further comprising shipping the apparatus (container 1700) to a destination (transported to an analysis site for analysis, col 1 lines 26-27) within an effective shipping time (stable from the time of collection to the time of analysis can have a significant impact on whether the samples can be successfully analyzed, col 3 lines 64-66) while maintaining a set of tolerable internal temperature limits (2-8° C, abstract) and an effective mean kinetic temperature range (the carrier includes an insulated phase change material (PCM) that can be pre-chilled to maintain biological samples at a refrigerated temperature (e.g., 2-8° C.) while the carrier is in transit and/or temporary storage protecting the samples from degradation, abstract).
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 non-obviousness.
Claims 2-4 and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Shindler (US 5405012 A) in view of Ma et al (WO 2018118876 A1, herein after referred to as Ma).
Regarding claim 2, Shindler teaches the invention as described above but fail to teach wherein the PCM pack is pre-conditioned at an effective charging temperature for an effective charging time.
However, Ma teaches wherein the PCM pack (PCM liner 18 including PCM 50, paragraph 0039) is pre-conditioned at an effective charging temperature (as described in paragraph 0039) for an effective charging time (as described in paragraph 0037).
Therefore, it would have been obvious to a person skilled in the art before the effective filing date of the invention to modify the system of Shindler to include wherein the PCM pack is pre-conditioned at an effective charging temperature for an effective charging time in view of the teachings of Ma in order to yield the predictable result of maintaining the beverage at or near the desired drinking temperature range for an extended period of time.
Regarding claim 3, the combined teachings teach wherein the PCM pack (figure 8 of Ma) comprises a first portion (lower PCM pod 130 of Ma) and a second portion (PCM pod 162 of Ma), the first portion comprising a first PCM (PCM 146 of Ma), the second portion comprising a second PCM (PCM 170 of Ma) different from the first PCM (as described in paragraphs 0055 and 0057 of Ma), the PCM pack (figure 8 of Ma) defining a payload cavity for a biological sample (reservoir 142, corresponding to sockets 14-16 of Shindler, as modified).
Regarding claim 4, the combined teachings teach further comprising an insulated stopper (stopper or plug assembly 82 of Ma) comprising a first plug (lower portion of plug, figure 4 of Ma) and a second plug (upper portion of plug 82, figure 4 of Ma).
Regarding claim 10, the combined teachings teach wherein the PCM pack (PCM liner 18 including PCM 50, paragraph 0039 of Ma) is a primary PCM pack (PCM 146 of Ma) comprising a first phase change material (paragraph 0055 of Ma), and wherein the temperature-controlled packaging system (container system 10 of Ma) further comprises a secondary PCM pack (PCM 170 of Ma), wherein the secondary PCM pack (PCM 170 of Ma) comprises a second phase change material (paragraph 0057 of Ma).
Regarding claim 11, the combined teachings teach wherein the secondary PCM pack (PCM 170 of Ma) is located vertically above (figure 1 of Ma) the primary PCM pack (PCM 146 of Ma), and wherein the payload cavity is further at least partially enclosed by the secondary PCM pack (reservoir 142 is partially enclosed by PCM pack 170, as shown on figure 8 of Ma).
Regarding claim 12, the combined teachings teach wherein a phase change temperature (20 °F and 50 °F, paragraph 0055 of Ma) of the first phase change material (PCM 146 of Ma) is lower (as described in paragraphs 0055 and 0057 of Ma) than a phase change temperature (130 °F and 150 °F, paragraph 0057 of Ma) of the second phase change material (PCM 170, paragraph 0057 of Ma).
Regarding claim 13, the combined teachings teach wherein a phase change temperature (as described in paragraph 0057 of Ma) of the second phase change material (PCM 170, paragraph 0057 of Ma) is in a range of -2 ° C to 15 ° C (paragraph 0057 of Ma) and wherein a phase change temperature (paragraph 0055 of Ma) of the first phase change material (PCM 146 of Ma) is in a range of 50°C to 25 °C (54°C, paragraph 0055 of Ma).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Shindler (US 5405012 A) in view of Wollny et al (US 20220341658 A1, herein after referred to as Wollny).
Regarding claim 5, Shindler teaches the invention as described above but fail to teach wherein the PCM pack serves both as a sink for heat energy and as a secondary interior layer of insulation.
However, Wollny teaches wherein the PCM pack (PCM, paragraph 0013) serves both as a sink for heat energy (for further cooling capacity, paragraph 0013) and as a secondary interior layer of insulation (the thermally insulated transport unit preferably further comprises cooling and insulation elements or layers and wherein the thermally insulated transport unit preferably further comprises phase change materials (PCM), paragraph 0013).
Therefore, it would have been obvious to a person skilled in the art before the effective filing date of the invention to modify the system of Shindler to include wherein the PCM pack serves both as a sink for heat energy and as a secondary interior layer of insulation in view of the teachings of Wollny in order to yield the predictable result of providing further cooling capacity.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Shindler (US 5405012 A) in view of Villette et al (US 20210172689 A1, herein after referred to as Villette).
Regarding claim 7, the combined teachings teach wherein the PCM pack (PCM, paragraph 0013 of Wollny) further comprises a rim (collar 138 of Wollny) and a pack outer wall (base 126 of Wollny).
The combined teachings teach the invention as described above but fail to teach wherein the pack outer wall and the rim entraps an air pocket between 0.2 mm and 5 mm thick between itself and an inner wall of the container.
However, Villette teaches wherein the pack outer wall (outer wall of PCM-PTD, as shown on figure 17) and the rim (corresponding to the collar 138 of Wollny) entraps an air pocket between 0.2 mm and 5 mm thick between itself and an inner wall of the container (a displacement greater than the 5 mm air gap 422 located at the bottom portion of the PCM-PTD, paragraph 0095).
Therefore, it would have been obvious to a person skilled in the art before the effective filing date of the invention to modify the system of the combined teachings to include wherein the pack outer wall and the rim entraps an air pocket between 0.2 mm and 5 mm thick between itself and an inner wall of the container in view of the teachings of Villette in order to yield the predictable result of inhibiting heat transfer from the pipeline to the environment.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Shindler (US 5405012 A) in view of Christie et al (US 20230144783 A1, herein referred to as Christie).
Regarding claim 9, Shindler teaches the invention as described above but fail to teach further comprising an insulated stopper, wherein the insulated stopper further comprises a sub-plug centered on the vertical axis of the container with a diameter equal to the payload cavity.
However, Christie teaches further comprising an insulated stopper (stopper 106, figure 1), wherein the insulated stopper (stopper 106, figure 1) further comprises a sub-plug (via end 154, figure 1) centered on the vertical axis (figure 1) of the container (container 102) with a diameter equal to the payload cavity (via opening 105, as shown on figure 1).
Therefore, it would have been obvious to a person skilled in the art before the effective filing date of the invention to modify the system of the combined teachings to include further comprising an insulated stopper, wherein the insulated stopper further comprises a sub-plug centered on the vertical axis of the container with a diameter equal to the payload cavity in view of the teachings of Christie in order to yield the predictable result of sealing portion extending over the upper sealing surface of the container.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Shindler (US 5405012 A), Ma et al (WO 2018118876 A1) in view of Blezard et al (US 20230251011 A1, herein after referred to as Blezard).
Regarding claim 14, the combined teachings teach the invention as described above but fail to teach wherein at least one of: the primary PCM pack and the secondary PCM pack are permanently bonded to each other; or the secondary PCM pack is permanently bonded to an insulated stopper.
However, Blezard teaches wherein at least one of: the primary PCM pack and the secondary PCM pack are permanently bonded to each other; or the secondary PCM pack (PCM bladder 100) is permanently bonded to an insulated stopper (via filling bung 130, paragraph 0074 and as shown on figure 16).
Therefore, it would have been obvious to a person skilled in the art before the effective filing date of the invention to modify the system of the combined teachings to include wherein at least one of: the primary PCM pack and the secondary PCM pack are permanently bonded to each other; or the secondary PCM pack is permanently bonded to an insulated stopper in view of the teachings of Blezard in order to yield the predictable result of allowing filling of the bladder with PCM.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Olson et al (US 12050052 B1) in view of Kang et al (KR 20050027378 A, herein referred to as Kang).
Regarding claim 17, Olson teaches the invention as described above but fail to teach wherein the PCM pack comprises a primary PCM pack, and wherein the method further comprises: incubating the primary PCM pack at an effective incubation temperature for an effective incubation time; placing the primary PCM pack into the vacuum shipper; and pressing an insulated stopper into the mouth of a vacuum shipper.
However, Kang teaches wherein the PCM pack comprises a primary PCM pack (heat transfer member 16 is preferably a PCM, paragraph 0023), and wherein the method further comprises: incubating the primary PCM pack at an effective incubation temperature (heat transfer member for maintaining a constant temperature, paragraph 0024) for an effective incubation time (a heat transfer member between the wine cooler body and the storage unit can maintain the cooling of the wine bottle for a long time, paragraph 0014); placing the primary PCM pack into the vacuum shipper (PCM within cooler body 10, figure 3); and pressing an insulated stopper into the mouth of a vacuum shipper (wine cooler equipped with a vacuum bottle stopper capable of maintaining a cooling effect for a long time, paragraph 0017).
Therefore, it would have been obvious to a person skilled in the art before the effective filing date of the invention to modify the system of Olson to include wherein the PCM pack comprises a primary PCM pack, and wherein the method further comprises: incubating the primary PCM pack at an effective incubation temperature for an effective incubation time; placing the primary PCM pack into the vacuum shipper; and pressing an insulated stopper into the mouth of a vacuum shipper in view of the teachings of Kang in order to yield the predictable result of providing a lower temperature to a wine bottle without ice by mounting a cooling element.
Regarding claim 18, the combined teachings teach wherein the effective incubation temperature is in a range between 0 °C and 10 °C (the phase change material is a material that changes from a solid phase to a liquid phase when heat is applied. In particular, the phase change material refers to a material in which a phase change occurs at an appropriate temperature, for example, 0 ° C. or lower, according to a change in a component, paragraph 0023 of Kang).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Olson et al (US 12050052 B1) in view of Duane et al (US 20220001378 A1, herein after referred to as Duane).
Regarding claim 20, Olson teaches wherein the effective mean kinetic temperature range is between 2°C and 20 °C (the carrier includes an insulated phase change material (PCM) that can be pre-chilled to maintain biological samples at a refrigerated temperature (e.g., 2-8° C.) while the carrier is in transit and/or temporary storage protecting the samples from degradation, abstract),
Olson teaches the invention as described above but fail to teach wherein the effective shipping time is in the range of 48 hrs. to 120 hrs.
However, Duane teaches wherein the effective shipping time (overnight shipping, paragraph 0092) is in the range of 48 hrs. to 120 hrs (at least 36 hours, paragraph 0092).
Therefore, it would have been obvious to a person skilled in the art before the effective filing date of the invention to modify the system of Olson to include wherein the effective shipping time is in the range of 48 hrs. to 120 hrs in view of the teachings of Duane in order to yield the predictable result of maintaining temperature control of the payload.
Allowable Subject Matter
Claims 6 and 15 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 6, the subject matter which is considered to distinguish from the closest prior art of record, Olson et al (US 12050052 B1). The prior art of record when considered as a whole, alone, or in combination, neither anticipates nor renders obvious “further comprising an insulated stopper, wherein: the container comprises a vacuum bottle comprising vacuum insulation, a mouth, an outer wall that is substantially vertical with respect to the mouth, and an inner wall that is tapered inward with respect to vertical at 0-5 degrees; the insulated stopper comprises a handle and a plug that has a friction fit with the mouth, wherein the insulated stopper comprises a thickness of at least 20 mm; the PCM pack has a pack outer wall that conforms to the inner wall of the vacuum bottle; and the payload cavity comprises at least 3 cc volume and is formed from a wall of the PCM pack, and wherein the payload cavity is at least partially enclosed by the PCM pack”. The closest prior art, teaches a refrigerated carrier device that can maintain biological samples including capillary blood samples at refrigerated temperatures is described herein. The carrier includes an insulated phase change material (PCM) that can be pre-chilled to maintain biological samples at a refrigerated temperature (e.g., 2-8° C.) while the carrier is in transit and/or temporary storage protecting the samples from degradation.
Regarding claim 15, the subject matter which is considered to distinguish from the closest prior art of record, Olson et al (US 12050052 B1). The prior art of record when considered as a whole, alone, or in combination, neither anticipates nor renders obvious “wherein: the container comprises a vacuum bottle, wherein the vacuum bottle comprises vacuum insulation, a mouth, an outer wall that is substantially vertical with respect to the mouth, and an inner wall that is tapered inward with respect to vertical at 0-5 degrees; the temperature-controlled packaging system further comprises an insulated stopper, wherein the insulated stopper comprises a handle and a plug that has a friction fit with the mouth, wherein the insulated stopper comprises a thickness of at least 20 mm; the PCM pack comprises a pack outer wall that conforms to the inner wall of the vacuum bottle; the payload cavity comprises a volume of at least 3 cc and is formed from a wall of the primary PCM pack; and the payload cavity is at least partially enclosed by the primary PCM pack”. The closest prior art, teaches a refrigerated carrier device that can maintain biological samples including capillary blood samples at refrigerated temperatures is described herein. The carrier includes an insulated phase change material (PCM) that can be pre-chilled to maintain biological samples at a refrigerated temperature (e.g., 2-8° C.) while the carrier is in transit and/or temporary storage protecting the samples from degradation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DARIO DELEON whose telephone number is (571)272-8687. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerry Daryl Fletcher can be reached at 571-270-5054. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DARIO ANTONIO DELEON/Examiner, Art Unit 3763
/JERRY-DARYL FLETCHER/Supervisory Patent Examiner, Art Unit 3763