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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Applicant’s response filed 10/23/2025 has been received and entered into the application file. All arguments have been fully considered.
Claims 16-21 from the claim set filed 10/23/2025 are pending. Claims 1-15 and 22-23 are cancelled.
Rejection(s) Withdrawn
Double Patenting
RE: Claims 16-22 are rejected on the grounds of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-5 and 7 of U.S. Patent No. 10,626,370 in view of Story (US 20110171186 A1, published July 14, 2011; PTO 892). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-5 and 7 of U.S. Patent No. 10,626,370, in view of Story, make obvious claims 16-22 of the instant application.
Applicant submitted a Terminal Disclaimer over US Patent NO 10,626,370. As such, the previously filed rejection is withdrawn.
Claims 16-22 are rejected on the grounds of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-5 and 7 of U.S. Patent No. 9,926,530 B2 in view of Story (US 20110171186 A1, published July 14, 2011; PTO 892). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-5 and 7 of U.S. Patent No. 9,926,530 B2, in view of Story, make obvious claims 16-22 of the instant application.
Applicant submitted a Terminal Disclaimer over US Patent NO 9,926,530. As such, the previously filed rejection is withdrawn.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
RE: Claims 16-18 and 21 are rejected under 103 as being unpatentable over Wood, in view of Story (US 20110171186 A1, published July 14, 2011; PTO 892).
Applicant amended claim 16 to include the limitations of now cancelled claim 22. As the previously filed rejection was not raised against previous claim 22, the previously filed rejection is withdrawn. However, Applicant amendment has necessitated new grounds of rejection, as set forth below.
RE: Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Wood, in view of Story, and further in view of Isono (previously cited).
For the reasons discussed above, the obviousness rejection over Wood in view of Story is withdrawn, and thus the obviousness rejections that are based on the same basis are likewise withdrawn. However, Applicant amendment has necessitated new grounds of rejection as set forth below.
RE: Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Wood, in view of Story and Isono, and further in view of LaBarre and Daly (previously cited).
Applicant amendment cancelled claim 22, thus making the rejection of said claim moot.
New ground(s) of Rejection, necessitated by Amendment
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 16-18 and 21 are rejected under 103 as being unpatentable over Hatano (Hatano, et al., Jpn. J. Infect. Dis. (2010) 63: 36-40; PTO 892), in view of Wang (US5205278A, published 4/27/1993; PTO 892), Stanley (US 4,077,390, published 3/7/1978; PTO 892), LaBarre (previously cited), and Tubo (US 5,786,217, published 7/28,1998; PTO 892), as evidenced by Anderson (Anderson, Stefan; Health Policy Watch, retrieved from the internet 6/16/2026: https://healthpolicy-watch.news/one-billion-people-lack-access-to-health-facilities-with-reliable-electricity/; PTO 892)
In regards to claims 16 and 17, Hatano teaches of loop-mediated isothermal amplification (LAMP) performed via the use of a disposable pocket warmer without the need for electricity (i.e., pocket-warmer LAMP) (Summary). As a POSITA will appreciate, and as is taught by Hatano, LAMP involves the use of the enzyme DNA polymerase (p37, LAMP).
Hatano teaches reaction tubes (i.e., a container containing a solution comprising an enzyme) were incubated via being sandwiched in a twofold pocket warmer (i.e., a warmer) surrounded by a paper towel and put in a Styrofoam box (i.e., a cavity of support) for 90 min (Fig 1A, p37 LAMP). Thus, Hatano teaches point ii) “bringing said warmer into contact with a container containing a solution comprising an enzyme by placing the warmer and at least the lower part of the container in a cavity of a support.”
Hatano, Fig 1A
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In regards to point iii) and “incubating at from 30 degrees C to 40 degrees C for at least 5 minutes”, Hatano teaches the LAMP method requires constancy of temperature at about 60 degrees Celsius for 60 min in order to amplify DNA. Hatano teaches of testing a commercially available disposable pocket warmer to determine if said pocket warmer is able to maintain said temperature for the appropriate period of time. Hatano teaches the heat released from said pocket warmer can have a temperature ranging from 35 degrees Celsius to 75 degrees Celsius for about several minutes to three hours (Column 4, lines 23-25). As can be seen in Fig 1B, the pocket warmer of Hatano maintains a temperature between 30-40 degrees Celsius for at least 5 minutes.
Hatano, Fig 1B
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Thus, Hatano teaches the use of a disposable pocket warmer without the need for electricity for use in an enzymatic reaction and further teaches a process for carrying out an in vitro biochemical reaction.
Hatano does not per se teach a hermetic plastic pouch containing a sodium acetate-saturated aqueous solution, the operation of which is based on an exothermic physical or chemical process. Rather, Hatano teaches of testing a commercially available disposable pocket warmer.
Wang teaches of portable pocket warmers/heat packs/chemical bag warmers (Column 1, lines 1-10, lines 43-51; Column 4, lines 36-61). Wang teaches according to the present invention, heat is to be generated by said pocket warmers/heat packs/chemical bag warmers by means of crystallization of sodium acetate in a bag (Column 3, lines 3-5). Wang teaches said pocket warmers/heat packs/chemical bag warmers comprise a plastic bag sealed completely; a sodium acetate solution (i.e., a sodium acetate-saturated aqueous solution) being filled in said sealed bag; a triggering member disposed in said sodium acetate solution; said triggering member being a disc-shaped member made of a flexible metal piece; said triggering member is adapted to vibrate and generate an oscillation wave when a pressure is applied thereupon, thereby causing said sodium acetate solution to crystalize and providing a warming effect through the dissipation of heat due to such crystallization (i.e., an exothermic physical process) (column 4, lines 35-61). Thus, Wang teaches of activating a warmer consisting of a sealed plastic pouch containing a sodium acetate saturated aqueous solution, the operation of which is based on an exothermic physical process.
Wang does not per se teach said warmer is hermetically sealed.
Examiner respectfully notes Wang references the teachings of Stanley (i.e., US Pat No 4,077,390) (Column 2, lines 43-50).
Stanley teaches a reusable heat pack made by enclosing a supercoolable aqueous sodium acetate solution (i.e., this reads on a sodium acetate saturated aqueous solution) together with a metallic activator strip in a sealed flexible container. Stanley teaches to prepare the heat pack for activation, its contents are first heated to a temperature above the melting point of sodium acetate to completely melt it. Thereafter, the sodium acetate solution is supercooled. Activation of crystallization of the sodium acetate (with evolution of heat) is produced by bending the activator strip (Abstract). Additionally, Stanley teaches said heat pack is sealed to make the heat pack fluid-tight (i.e., this reads on hermetically sealed) (Column 2 lines 65-68 – Column 3 lines 1-3). Further, Stanley teaches heat packs of various types have long been used in the medical field and by sportsmen for the purpose of applying heat to localized areas of the body to, for example, alleviate stiffness and minimize damage due to freezing of the skin (Column 1, lines 10-15).
Thus, it would have been obvious to a POSITA, before the effective filing date of the claimed invention, to combine the teachings of Wang and Stanley. A POSITA would have been so motivated to combine said teachings due to Wang referencing the teachings of Stanley. As such, it would have been obvious to combine the sealed (but not specified as hermetically sealed) heat pack of Wang with the fluid-tight sealed (i.e., hermetically sealed) heat pack of Stanley in order to ensure said heat packs were sealed tight to prevent leakage. A POSITA would have had a reasonable expectation of combining said teachings due to both Wang and Stanley utilizing heat packs and of Wang referencing the teachings of Stanley.
Thus, as Wang and Stanley teach of a portable hermetically sealed plastic pouch containing a sodium acetate-saturated aqueous solution (i.e., a pocket warmer/heat pack) and Hatano teaches of drugstore pocket warmers for carrying out an in vitro biochemical reaction, it would have been obvious to a POSITA before the effective filing date of the claimed invention, to do a simple substitution of one known element for another to obtain predictable results. It would have been obvious to substitute the pocket warmer of Hatano for the pocket warmer of Wang/Stanley. A POSITA would have had a reasonable expectation of successfully substituting said pocket warmers for use in a no-electricity needed incubator for a biological reaction. Substitution of one element for another known in the field is considered to be obvious, absent a showing that the result of the substitution yields more than predictable results. See KSR International Co. v Teleflex Inc 82 USPQ2d 1385 (US 2007) at page 1395.
Thus, Hatano, Wang and Stanley have established the use of a “pocket warmer” made of a hermetic plastic pouch containing a sodium acetate-saturated aqueous solution for use as the heat source in an incubator that thus does not require electricity. Further, the teachings of Hatano, Wang and Stanley have established said “pocket warmer incubator” may be used for such biological reactions as LAMP.
In regards to prior art teaching of an incubator employing the use of a sodium acetate-saturated aqueous solution for use in incubation between 30-40 degrees Celsius for at least 5 minutes, Examiner respectfully notes, as noted above, Hatano teaches the heat released from said pocket warmer can have a temperature ranging from 35 degrees Celsius to 75 degrees Celsius for about several minutes to three hours (Column 4, lines 23-25). Further, as can be seen in Fig 1B above, the pocket warmer of Hatano maintains a temperature between 30-40 degrees Celsius for at least 5 minutes. Thus, Hatano teaches a pocket warmer incubator that can maintain a temperature between 30-40 degrees Celsius for at least 5 minutes.
Examiner notes the work of Hatano is directed to the use of “pocket warmer incubators” for use with LAMP. Further, Hatano teaches the LAMP method requires constancy of temperature at about 60 degrees Celsius for 60 min in order to amplify DNA. As such, the work of Hatano is focused on said pocket warmer incubators maintaining a temperature at about 60 degrees Celsius for 60 min.
Examiner notes the instant application is directed to pocket warmer (i.e., sodium acetate) incubation from 30-40 degrees Celsius for at least 5 minutes.
LaBarre teaches of simple and inexpensive devices for biological reactions without electricity and specifically teaches of electricity-free heaters based on exothermic chemical reactions (Abstract). LaBarre teaches of exploring heaters with sodium acetate (NaAc). LaBarre teaches hand warmers based on the crystallization of NaAc are common. LaBarre teaches in a purified form, at typical ambient temperatures, liquid NaAc is thermodynamically unstable but kinetically stable due to the absence of nucleating sites for crystal formation. The application of a mechanical shock initiates the exothermic crystallization, and when mixed as a 25% aqueous solution the phase change occurs repeatably at about 37 degrees Celsius for at least 10 minutes (Fig 4B). LaBarre notes this system has the advantage of being regenerable. LaBarre additionally notes for diagnostic applications requiring heating, NaAc is the preferred exothermic/phase change system (p19738 last paragraph – top of pe19739; Fig 4B).
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Thus, it would have been obvious to a POSITA, before the effective filing date of the claimed invention, to combine the teachings of Hatano, Wang, Stanley and LaBarre in order to have an inexpensive and electricity free incubator via the use of sodium acetate hand warmers as taught by both Hatano/Wang/Stanley and LaBarre. A POSITA would have been so motivated to combine said teachings due to both Hatano/Wang/Stanley and LaBarre studying the effect of sodium acetate hand warmers as incubators and due to LaBarre teaching for diagnostic applications requiring heating, NaAc is the preferred exothermic/phase change system and further due to LaBarre teaching said hand warmers are able to maintain about 37 degrees Celsius for at least 10 minutes. A POSITA would have had a reasonable expectation of success in combining said teachings due to all studying sodium acetate hand warmers.
Thus, the teachings of Hatano, Wang, Stanley and LaBarre teach of an electricity free incubator powered via sodium acetate hand warmers that is able to maintain a temperature between 30-40 degrees Celsius for at least 5 minutes.
In regards to preparing a cell suspension from a patient’s tissue sample, said tissue sample selected from the group consisting of cartilage, a testicular biopsy, a pancreatic biopsy and a gingival biopsy, Tubo teaches of isolating chondrogenic cells from pre-existing cartilage tissue (Column 6, lines 18-27). Tubo teaches articular cartilage tissue samples may be subjected to enzymatic treatment in order to disaggregate the tissue and release chondrogenic cells. Tubo teaches the use of proteolytic enzymes such as trypsin (claim 17) to digest said articular cartilage tissue. Tubo teaches incubating with 0.05% trypsin at 37 degrees Celsius for at least 5 minutes (Column 10, lines 24-55). Tubo teaches of isolating chondrogenic cells from said tissues (Column 6, lines 26-27). Tubo teaches of suspending cells in a solution to provide a cell suspension (Column 12, lines 8-64). Tubo teaches of performing diagnostic tests on said cells to determine chondrogenic potential (Column 12 lines 64-67 – Column 13 lines 1-67).
Thus, Tubo teaches of cartilage tissue digestion for cell suspension which requires enzymatic digestion at 37 degrees Celsius for at least 5 minutes.
As noted supra, LaBarre teaches of simple and inexpensive devices for biological reactions without electricity. Further, La Barre notes the World Health Organization recommends that diagnostic devices for developing countries should be ASSURED: Affordable, Sensitive, Specific, User-friendly, Rapid and robust, Equipment free, and Deliverable to end users (pe19739, 1st paragraph). Additionally, as is evidenced by Anderson, nearly one billion people in low- and middle-income countries lack access to health facilities with reliable electricity (p1, 1st paragraph).
Thus, it would have been obvious to a POSITA, before the effective filing date of the claimed invention, to combine the teachings of Hatano/Wang/Stanley/LaBarre with the teachings of Tubo in order to have a low cost, electricity free incubator (as taught by Hatano/Wang/Stanley/LaBarre) for preparing a cell suspension from a patient’s tissue sample (i.e., cartilage) (as taught by Tubo). A POSITA would have been so motivated to combine said teachings due to Hatano/Wang/Stanley/LaBarre teaching of a low cost, electricity free incubator which maintains a temperature between 30-40 degrees Celsius for at least 5 minutes, further due to Tubo teaching a procedure of isolating a cell suspension from a cartilage sample which utilizes an enzymatic reaction incubated between 30-40 degrees Celsius for at least 5 minutes, and further due to Anderson evidencing nearly one billion people in low- and middle-income countries lack access to health facilities with reliable electricity. A POSITA would have had a reasonable expectation of success in combining said teachings due to Hatano/Wang/Stanley/LaBarre teaching of a low cost electricity free incubator capable of performing enzymatic digestion between 30-40 degrees Celsius for at least 5 minutes and due to Tubo teaching of tissue digestion for a cell suspension requiring enzymatic digestion of tissue at 7 degrees Celsius for at least 5 minutes.
Thus, claims 16 and 17 are obvious and are properly rejected.
In regards to claim 18, the above cited references teach the process as claimed in claim 16. Further, LaBarre teaches NaAc maintaining about 37 degrees Celsius for at least 10 minutes (Fig 4B). Additionally, Tubo teaches incubating with 0.05% trypsin at 37 degrees Celsius for at least 10 minutes (Column 10, lines 24-55).
Moreover, Examiner notes absent any teaching of criticality or unexpected result by the Applicant, it would be obvious that one of ordinary skill in the art would recognize that contact time (i.e., incubation time) between the warmer and the container [comprising the enzymatic solution and tissue sample] is a result effective variable and Examiner notes that the optimization of contact time (i.e., incubation time) would have been prima facie obvious to one of ordinary skill in the art at the time of filing. Examiner notes incubation time, i.e., contact time, is dependent upon such variables as type and amount of tissue to be digested and concentration of the enzymatic solution.
Generally, differences in parameters will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (see MPEP 2144.05).
Thus, the claim is obvious and is properly rejected.
In regards to claim 21, the above cited references teach the process as claimed in claim 17. Additionally, Tubo teaches incubating with 0.05% trypsin at 37 degrees Celsius for at least 10 minutes (Column 10, lines 24-55).
Examiner notes absent any teaching of criticality or unexpected result by the Applicant, it would be obvious that one of ordinary skill in the art would recognize that the concentration of trypsin is a result effective variable and Examiner notes that the optimization of said concertation would have been prima facie obvious to one of ordinary skill in the art at the time of filing. Examiner notes trypsin concentration for enzymatic digestion is dependent upon such variables as the type and amount of tissue to be digested as well as the amount of time for said digestion.
Generally, differences in parameters will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (see MPEP 2144.05).
Thus, the claim is obvious and is properly rejected.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hatano (Hatano, et al., Jpn. J. Infect. Dis. (2010) 63: 36-40; PTO 892), in view of Wang (US5205278A, published 4/27/1993; PTO 892), Stanley (US 4,077,390, published 3/7/1978; PTO 892), LaBarre (previously cited), and Tubo (US 5,786,217, published 7/28,1998; PTO 892), as evidenced by Anderson (Anderson, Stefan; Health Policy Watch, retrieved from the internet 6/16/2026: https://healthpolicy-watch.news/one-billion-people-lack-access-to-health-facilities-with-reliable-electricity/; PTO 892), and further in view of Isono (previously cited) and evidenced by HotSnapZ (HotSnapZ, retrieved from the internet 6/16/2026: https://hotsnapz.com/products/hotsnapz-variety-pack-w-round-hand-warmers?srsltid=AfmBOooUrIYtHwSXUwH1kVofw-tYjHmSEIu2SIdmE7wp0rKYBd4GJja9; PTO 892).
In regards to claims 19 and 20, the above cited references teach the process as claimed in claim 16. Tubo teaches the volume of the solution comprising the enzyme is 1 ml (Column 10, line 48). Tubo does not teach the volume comprising the enzyme is from 3-10 mls.
Examiner notes absent any teaching of criticality or unexpected result by the Applicant, it would be obvious that one of ordinary skill in the art would recognize that the volume of solution comprising the enzyme is a result effective variable and Examiner notes that the optimization of said volume would have been prima facie obvious to one of ordinary skill in the art at the time of filing. Examiner notes volume for enzymatic digestion is dependent upon such variables as the type and amount of tissue to be digested, the specific enzyme used, as well as the amount of time for said digestion.
Generally, differences in parameters will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (see MPEP 2144.05).
In regards to the limitations directed to “the container containing said solution comprising the enzyme is a Petri dish having a diameter of from 7 to 11 cm or a compartment of said dish and wherein the warmer is a disk of which the thickness is from 3 to 7 mm and the diameter is from 7 to 11 cm”, [i.e., claim 19] Examiner notes the above cited references do not teach of said limitations. Nor do the above cited references teach “wherein the cavity of support is circular, with a diameter from 7 to 11.5 cm and a depth from 5 to 20mm” [i.e., claim 20].
As can be seen by perusing the art, the size of the warmer and said container is a matter of routine optimization. Whether or not one uses a vial or a petri dish would affect the size of the warmer one would wish to use. For example, Hatano teaches the use of reaction tubes (Fig 1) rather than petri dishes for the enzymatic reaction.
Examiner respectfully offers the teachings of Isono below to further bolster the argument that a warmer, such as is claimed by the instant application, is not novel and the exact dimensions and sizes are a matter of routine optimization. Examiner also offers Isono as an example of a warmer teaching the cavity of support is a circular petri dish, as opposed to the vial/tube taught by Hatano.
Isono teaches of a culture vessel for controlling the cell culture environment. The culture vessel includes temperature control through an electroconductive film (i.e., through an exothermic physical process). Isono teaches of petri dishes as the culture vessels (Abstract). Isono teaches said culture vessel improves the accuracy of the culture environment and is a simple and inexpensive form (1st paragraph, p2).
FIG. 8A shows a well plate (i.e., 41) for 6 holes in which the bottom transparent plate (i.e., 35) is attached to the bottom surface of the dish portion and the top transparent plate (i.e., 1) is attached to the top surface of the lid portion. FIG. 8B is a sectional view thereof. The shape of a general well plate (i.e., 41) has an outer diameter of 85 mm × 127 mm, and the well plate is an example in which six wells having a diameter of 35 mm (i.e., 3.5cm) are arranged. FIG. 8 is a top view of the well plate for 6 holes, respectively. FIG. 8B is a sectional view thereof.
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FIG. 4A shows the inner surface (i.e., 12b) of the top lid portion of the container (i.e., petri dish), the inner surface (i.e., 13a) and the lower, outer surface (i.e., 13b) of the plate portion to which the bottom transparent plate (i.e., 35) is attached, and the outer peripheral side surface portion 13c (p4).
FIG. 3 is a perspective view of a transparent conductive film (i.e., warmer) first formed on the upper surface (i.e., 35a) and the lower surface (i.e., 35b) of the bottom transparent plate. (B) is a sectional view thereof (p4).
In FIG. 4A, the inner surface (12b) of the lid portion of the container is processed with a transparent conductive film. The outer surface (12a) of the lid portion is coated with a transparent antibacterial agent (60). It is a perspective view. (B) is a sectional view thereof (p4).
In addition, in FIG. 3 and FIG. 4, the transparent conductive film (15) used for the upper surface (35a) of the bottom transparent plate can use ITO ink (fine particles) by a coating method. The transparent conductive film is characterized by a particle size distribution state of a nano-unit particle diameter, and has the property of conductivity (p4).
Similarly, in FIG. 3 and FIG. 4, a DLC film that is a diamond-like carbon film can be used as the conductive film used for the upper surface (35a) of the bottom transparent plate (p4).
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Thus, Isono teaches of a warmer, i.e., a conductive film, which would inherently be activated for use, the operation of which is based on an exothermic process, for use in cell cultures contained in petri dishes. Isono further teaches of placing said warmer and at least the lower part of the petri dish in a cavity of support, i.e., the well plate.
As is made obvious above, the size of the petri dish or the vials used is a matter of routine optimization. Said optimization would have been obvious and well-within the purview of the ordinarily skilled artisan at the time of filing.
“[W[here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. “In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (see MPEP 2144.05).
“A change in form, proportions, or degree will not sustain a patent" see Smith v. Nichols, 88 U.S. 112, 118-19 (1874).
"It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." In re Williams, 36 F.2d 436, 438 (CCPA 1929)
Further, and specifically in regards to sodium acetate warmers, examiner respectfully notes, as is evidenced by HotSnapZ, that sodium acetate hand warmers such as HotSnapZ come in a variety of sizes (i.e., 10” x 7”, 5.5” x 3.5”, 4”) and shapes (rectangular and circular) (p9). Further, HotSnapZ notes they are made of sodium acetate (p10).
Thus, the claims are obvious and are properly rejected.
Response to Remarks
Rejection under 35 USC 103:
In regards to Applicant remarks, Examiner respectfully notes the sole references remaining from the previously filed rejections are LaBarre and Isono.
In regards to LaBarre, Applicant states LaBarre does not disclose or suggest:
-a process for preparing a cell suspension from a patient’s tissue sample;
- tissue samples selected from cartilage, testicular biopsy, pancreatic biopsy, or gingival biopsy;
- the step of bringing the warmer into contact with a container containing a
solution comprising an enzyme by placing the warmer and at least the lower part of the container in a cavity of a support; or
- an incubation temperature between 30°C and 40°C;
Applicant additionally states LaBarre does not per se teach the sodium acetate is in a hermetic plastic pouch. (Page 27 of the office action) Its technical field (isothermal DNA amplification) and temperature range (~65°C) are far removed from those of enzymatic tissue dissociation.
Examiner respectfully notes LaBarre is not relied upon for said teachings. LaBarre is relied upon for teaching of electricity free heaters based on exothermic chemical reactions and engineered phase change materials and further for teaching of exploring different heaters such as heaters with sodium acetate (NaAc), such as hand warmers.
In regards to Isono, Applicant states Isono is cited as reflecting the general knowledge of the skilled artisan, illustrating the use of heating means with culture vessels. However, Isono discloses a cell culture vessel (Petri dish) comprising a transparent electrically conductive film serving as a heater, along with a current detection sensor unit (see claims). Therefore, Isono teaches electrical heating elements, not exothermic or sodium acetate-based warmers. It does not relate to any biochemical reaction for preparing a cell suspension from tissue samples, nor does it mention cartilage, testicular, pancreatic, or gingival biopsies.
Examiner respectfully notes Isono is not relied upon for teaching exothermic or sodium acetate-based warmers. Nor is Isono relied upon for teaching any biochemical reaction for preparing a cell suspension from tissue samples, nor is Isono relied upon for teaching cartilage, testicular, pancreatic, or gingival biopsies. Rather, Isono is relied upon for teaching the exact dimensions and sizes of a warmer are a matter of routine optimization. Examiner also offers Isono as an example of a warmer teaching the cavity of support is a circular petri dish, as opposed to the vial taught by Hatano.
As such, Applicant remarks have been carefully considered but have not been found persuasive.
Conclusion
No claim is allowed. No claim is free of the prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE R SMALL whose telephone number is (703)756-4783. The examiner can normally be reached Monday - Friday 8:30am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chris Babic can be reached on 571-272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE R SMALL/Examiner, Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633
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