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 .
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 6 is 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.
With regard to Claim 6, line 3, “other inert gases” is indefinite as there is no definition of what is included in “other inert gases” in the instant specification such that the scope of the claim is unclear.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Pawliszyn et al (US 2015/0318158) in view of Fuchs (“Drying – the effect of temperature on relative humidity”).
With regard to Claim 1, Pawliszyn et al (Pawliszyn) discloses a device for generating ionized molecules for analysis in a mass spectrometer (Abstract). The device includes a mesh substrate coated with an extraction phase, the extraction phase comprising a polymer and solid phase microextraction (SPME) particles having pores dimensioned to absorb a molecule of interest from a matrix (Abstract).
Pawliszyn discloses a method for drying a coating suitable for bio-compatible SPME in a flow-through drying system ([0062], the polymer of the extraction phase is preferably a biocompatible polymer; [0021], after applying a layer of coating, the coating substrate is passed through a flow of an inert gas to remove most excess coating solution that remains accumulated in mesh openings; [0022], after the excess coating solution is removed from the mesh substrate, the coated mesh substrate can be passed through a heater at an elevated temperature to remove at least a portion of the solvent; the elevated temperature can be from about 120°C to about 300°C).
Pawliszyn discloses introducing a device comprising a BioSPME coating into the drying system ([0021]-[0022], as above; and any means known to a person of ordinary skill in the art to remove the solvent can be used to dry the coated substrates).
However, Pawliszyn is silent to determining relative humidity at 22 ± 2°C (RH%) of the drying system, selecting an appropriate drying temperature range for the drying system based on the RH% of the drying system, adjusting the temperature of the drying system within the selected temperature range, and maintaining the temperature of the drying system within the selected temperature range for a time sufficient to dry the coating.
Fuchs discloses that a common method of drying is evaporation, which is usually enhanced through the use of heat and the movement of air over the parts (Page 1). Fuchs discloses that as the temperature of air is increased, it can absorb more liquid, and, therefore, the relative humidity is decreased, with lower relative humidity promoting faster drying (Page 1). Fuchs discloses that the rate of evaporation is driven by the relative humidity to a greater degree than by temperature (Page 1).
Based on the teachings of Fuchs, it would be obvious to determine the relative humidity of an evaporation system at room temperature (22 ± 2°C) of an evaporative drying system in order to determine if the temperature needs to be increased in order to decrease the relative humidity. One of ordinary skill in the art would be motivated to decrease the relative humidity in order to increase the rate of evaporation, as taught by Fuchs. One of ordinary skill in the art would be motivated to use both heat and the movement of air over the BioSPME coating, as taught by Fuchs, in order to enhance evaporation and drying of the coating.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to determine the relative humidity at 22 ± 2°C (RH%) of the drying system of Pawliszyn, select an appropriate drying temperature range for the drying system based on the RH% of the drying system, adjust the temperature of the drying system within the selected temperature range, and maintain the temperature of the drying system within the selected temperature range for a time sufficient to dry the coating, as taught by Fuchs, in order to decrease the relative humidity by increasing the temperature, thus increasing the rate of evaporation and drying of the BioSPME coating.
With regard to Claims 2-5, modified Pawliszyn is silent to wherein when the RH% is greater than 60%, the drying temperature is maintained in the range from 110°C to 160°C (Claim 2), wherein when the RH is in the range from 40% to 60%, the drying temperature is maintained in the range from 80°C to 110°C (Claim 3), wherein when the RH is in the range from 15% to 40%, the drying temperature is maintained in the range from 60°C to 80°C (Claim 4), wherein when the RH is less than 15%, the drying temperature is maintained in the range from 10°C to 50°C (Claim 5).
Fuchs discloses that as the temperature of air is increased, it can absorb more liquid, and, therefore, the relative humidity is decreased, with lower relative humidity promoting faster drying (Page 1). Fuchs discloses that the rate of evaporation is driven by the relative humidity to a greater degree than by temperature (Page 1).
As the rate of evaporation for drying is a variable that can be modified, among others, by increasing the temperature to decrease the relative humidity, the precise optimization of temperature based on the relative humidity would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed wherein when the RH% is greater than 60%, the drying temperature is maintained in the range from 110°C to 160°C (Claim 2), wherein when the RH is in the range from 40% to 60%, the drying temperature is maintained in the range from 80°C to 110°C (Claim 3), wherein when the RH is in the range from 15% to 40%, the drying temperature is maintained in the range from 60°C to 80°C (Claim 4), wherein when the RH is less than 15%, the drying temperature is maintained in the range from 10°C to 50°C (Claim 5) cannot be considered critical. See Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989)(Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the selection of temperature based on the relative humidity in the method of modified Pawliszyn to optimize the rate of evaporation for drying the BioSPME coating (KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007); Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969)), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See also MPEP §2144.05(II)(A).
With regard to Claim 6, Pawliszyn discloses wherein the drying system comprises a drying gas, and the drying gas is selected from the group consisting of air, nitrogen, and other inert gases ([0022], high purity gases such as nitrogen, argon, or helium can be used to remove the excess coating solution).
With regard to Claim 7, Pawliszyn discloses wherein the BioSPME coating comprises a binder and a sorbent (Abstract, the coating comprises an extraction phrase comprising a polymer (binder) and SPME particles (sorbent)).
With regard to Claims 8 and 9, Pawliszyn discloses wherein the binder comprises PAN and the sorbent comprises C-18, C-8, or mixed-mode functionalized silica ([0016], SPME particles may be C-18 silica; [0020], polymer may be PAN).
With regard to Claim 10, Pawliszyn discloses wherein the sorbent is a polymeric resin selected from the group consisting of HLB resins, divinylbenzene resins, styrene resins, divinylbenzene-co-styrene resins and combinations thereof ([0019], HLB).
With regard to Claim 11, Pawliszyn discloses a device for solid phase microextraction (Abstract). With regard to Claim 11, lines 1-2, “made by the method of claim 1” is a product-by-process limitation. MPEP § 2113 states that “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”. Therefore, the structure implied by the process steps of “made by the method of claim 1” will be considered when assessing patentability of Claim 11. However, the Applicant should note that “the Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). See MPEP § 2113(II).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN LEBRON whose telephone number is (571)272-0475. The examiner can normally be reached 9 AM - 5:30 PM.
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, Vickie Kim can be reached at 571-272-0579. 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.
Benjamin Lebron
Primary Examiner
Art Unit 1777
/BENJAMIN L LEBRON/Primary Examiner, Art Unit 1777