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 .
Summary
Claims 1-7 and 9-22 are pending. Claims 1-7 and 9-22 are rejected herein. This is a Non-Final Rejection after the amendment, arguments, and Request for Continued Examination (hereinafter “the Response”) dated 19 Dec 2025.
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.
Claim(s) 22 is/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 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.
Claim(s) 1-7, 9-16, and 19-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over HIRAI et al. (US 5,694,196) in view of KAMIYAMA et al. (US 2010/0071445) and MUNT et al. (US 2018/0259438).
Regarding claims 1 and 19: HIRAI discloses: A temperature control system (FIG. 7) for a static diffusion cell (FIG. 7) comprising: a cell head (Left side of 2, the donor chamber); and a temperature control device, wherein the temperature control device comprises an inlet (24) into the cell head for supplying a temperature control fluid (solution as discussed in col. 4 lines 30-58) into an interior portion of the cell head (Arrows at 23 and 24 in FIG. 7. Please note that the circulation of solution will control the temperature as the solution will be heated by conduction from the water jacket as discussed in col. 4 lines 40-58.).
HIRAI does not disclose that the diffusion cell is vertical.
KAMIYAMA teaches both a horizontal diffusion cell (FIG. 6) and a vertical one (FIG. 11). KAMIYAMA also teaches using aluminum for the components (para. 45) for its lightweight and excellent formability, thus meeting the limitations of claim 19.
One skilled in the art would be motivated to use a vertical diffusion cell as taught by KAMIYAMA because if one is testing a transdermal formulation on a layer of skin, air bubbles will not be trapped at the surface of the skin (para. 55).
HIRAI does not specify a temperature.
MUNT however teaches a similar diffusion cell with a temperature equilibrium of 20-50 degrees C (para. 72).
One skilled in the art would be motivated to use a temperature in this range such as 37 degrees C because that is the temperature of the human body and both HIRAI (col. 1 lines 10-15) and MUNT (para. 2) teach that their diffusion cells can be used to study the transfer of drugs.
Regarding claim 2: HIRAI discloses: the temperature control device is integrally formed with the cell head (FIG. 7 shows the inlet 24 and outlet 23 integrally formed with cell body 2. Please note that the water jacket 25 is also integrally formed with the cell 2.)
Regarding claim 3: HIRAI discloses: the temperature control device comprises a fluid heat exchanger (The water jacket 25 circulates fluid that exchanges heat with the solution in the donor chamber of the cell 2 as discussed in col. 4 lines 43-49.).
Regarding claim 4: HIRAI discloses: the cell head has a hollow cylindrical shape (Because the sample membrane 5 is circular, the cell head 2 is cylindrical.).
Regarding claim 5: HIRAI discloses: the cell head (left/donor chamber of 2) further comprises: an outlet (23) for discharging the temperature control fluid, from the interior portion of the cell head (FIG. 7).
Regarding claim 6: HIRAI discloses: the fluid inlet (24 in FIG. 7) and outlet (23) of the cell head (left/donor side of 2) are arranged opposite or vertically offset from one another (FIG. 7).
Regarding claim 7: HIRAI discloses: the temperature control fluid comprises water (Because the fluids mimic bodily fluids as discussed in col. 5 line 64-col. 6 line 5, they contain water.).
Regarding claim 9: HIRAI discloses: a temperature controller or a thermometer (Inherent in “controlled at the desired temperature” as discussed in col. 4 lines 43-58.).
Regarding claim 10: HIRAI discloses: the cell head comprises metal (The cell 2 comprises a magnetic stirrer 3 which is made of metal.).
Regarding claim 11: HIRAI discloses: A diffusion cell comprising; a temperature control system according to claim 1 (The rejection of claim 1 has been discussed above.) an acceptor chamber (right side of 2 in FIG. 7) connected to the temperature control system (FIG. 7); and a membrane (5), arranged between the temperature control system and the acceptor chamber (FIG. 7).
Regarding claim 12: HIRAI discloses: the cell head (left side of 2 in FIG. 7) and the acceptor chamber (right side of 2 in FIG. 7) are separated from each other in a fluid-tight manner (at 21), via the membrane (5; col. 4 lines 19-29).
Regarding claim 13: HIRAI discloses: A diffusion cell system comprising at least one temperature control system according to claim 1 (The rejection of claim 1 has been discussed above.); and a fluid provision device (left circulation loop 70 in FIG. 7); wherein the fluid provision device is connected to the temperature control system in a fluid-carrying manner (FIG. 7).
Regarding claim 14: HIRAI discloses: A method for controlling the temperature of a cell head of a diffusion cell, comprising the following step: introducing a temperature control fluid into the cell head of the diffusion cell of claim 1 so as to control the temperature of an interior portion of the cell head (As discussed above, the water jacket will conduct heat to the solution flowing through the left side of cell body 2 as shown in FIG. 7 and discussed in col. 4 lines 42-58.).
HIRAI does not specify a temperature.
MUNT however teaches a similar diffusion cell with a temperature equilibrium of 20-50 degrees C (para. 72).
One skilled in the art would be motivated to use a temperature in this range such as 37 degrees C because that is the temperature of the human body and both HIRAI (col. 1 lines 10-15) and MUNT (para. 2) teach that their diffusion cells can be used to study the transfer of drugs.
Regarding claim 15: HIRAI discloses: The method according to claim 14, wherein the method is carried out by means of the temperature control system of claim 1 (discussed above), wherein the cell head of the temperature control system is a donor chamber (the left side of cell body 2).
Regarding claim 16: HIRAI discloses: A diffusion cell system comprising a diffusion cell according to claim 11 (The rejection of claim 11 is discussed above.); and a fluid provision device (The left fluid loop 70), wherein the fluid provision device is connected to the at least one temperature control system in a fluid-carrying manner (at connections 24 and 23).
Regarding claim 20: HIRAI discloses: the cell head (left side of 2 in FIG. 7) and the acceptor chamber (right side of 2) are separated from each other in a fluid-tight manner by means of at least one seal (at 21; col. 4 lines 19-29) or a retaining clip, via the membrane (5).
Regarding claim 21: HIRAI discloses: the cell head (left side of 2 in FIG. 7) and the acceptor chamber (right side of 2) are separated from each other in a fluid-tight manner via the membrane (5; col. 4 lines 19-29), wherein the membrane (5) is located in a connection area of the cell head and the acceptor chamber (FIG. 7).
Regarding claim 22: HIRAI discloses: the temperature control fluid is provided by a fluid provision device (area around inlets 24 in FIG. 7), and wherein the fluid provision device comprises a heat exchanger (with fluid in water jacket 25) and/or a temperature controller for temperature control of the temperature control fluid being supplied through the inlet.
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over HIRAI, KAMIYAMA, and MUNT in view of CIMA et al. (US 2003/0170610).
Regarding claims 17-18: HIRAI does not disclose that the temperature control fluid further comprises alcohol mixed with the water.
CIMA however does teach a diffusion cell (para. 130) that can be used for transdermal testing (para. 130) and can include ethylene glycol as a chemical enhancer (para. 100-101).
One skilled in the art at the time the application was effectively filed would be motivated to use the ethylene glycol of CIMA in the solution of HIRAI as modified by KAMIYAMA because when doing testing in a diffusion cell, chemical enhancers can enhance the molecular transport rate across the tissue or membrane (para. 100-101 of CIMA.)
Response to Amendment/Argument
The amendment to claim 19 is acknowledged and the previous objection thereto is accordingly withdrawn.
The Applicant has argued (pages 6-7 of the Response) that the fluid of HIRAI is passively heated via the water jacket and therefore is not supplied at a temperature in the range of 37-51 degrees C. The Examiner agrees that HIRAI does not specify a temperature, therefore MUNT has been introduced to address this limitation as necessitated by amendment.
The Applicant has argued (pages 6-7 of the Response), that because the interior fluid of HIRAI is passively heated via the water jacket, it is not supplied in the temperature range required. The Applicant argues (page 8 of the Response) that the fluid must be heated before entering the cell head to meet this limitation. This argument has been fully considered and is not persuasive. FIG. 7 of HIRAI has been relied upon in the rejections of claims 1 and 14. FIG. 7 shows that the fluid is constantly entering and exiting the left and right sides of cell 2 as it is circulated through tubes 70. Therefore once thermal equilibrium is reached, the fluid will constantly be supplied at whatever temperature the experiment is operating at. Again, MUNT has been introduced to show that the specific range of 37 to 51 degrees C is obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHANIEL J KOLB whose telephone number is (571)270-7601. The examiner can normally be reached M-F 9-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JESSICA HAN can be reached at (571) 272-2078. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHANIEL J KOLB/Examiner, Art Unit 2896