DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant’s election without traverse of Group I in the reply filed on 23 April 2026 is acknowledged.
Claim 44 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 23 April 2026.
Claims 1-14, 29-32, and 43 are under prosecution.
Specification
3. The abstract of the disclosure is objected to because the abstract. The abstract should be limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
4. The use of trade names or marks used in commerce (including but not necessarily limited to Pekasol), has been noted in this application. Any trade names or marks should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Information Disclosure Statement
5. The Information Disclosure Statements filed 17 July 2023 and 5 January 2026 are acknowledged and have been considered.
It is noted that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Interpretation
6. The claims are subject to the following interpretation.
A. It is noted that the courts have held that “while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function.” In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997). In addition, “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). Therefore, the various uses recited in the claims (e.g., preparing a DNA product, guiding a PCR liquid, etc.) fail to define additional structural elements of the claimed device. Because the cited prior art teaches the structural elements of the claim, the claim is anticipated by, or alternatively obvious over, the cited prior art. See MPEP § 2114.
B.I. 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.
B.II. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being analyzed 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: the “control unit configured to control a gas flow…” in claim 31.
However, a review of the specification yields no limiting definition of the claimed control unit. Therefore, this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because there is no corresponding limiting structure described in the specification as performing the claimed function, and equivalents thereof.
If Applicant does 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 present a sufficient showing specification provides a limiting definition for the claim limitation(s) so as to warrant interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
7. 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.
8. Claims 1-14, 29-32, and 43 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.
A. Claims 1-14, 29-32, and 43 are indefinite in each of the parenthetical numberings (e.g., (1), (6), (7), (8) in claim 1) found throughout the claims. It is unclear if the numbering limits the claims to the specific structures presented in the drawings.
B. Claim 32 is indefinite in the recitation “preferably,” as it is unclear if the “preferable” limitation is actually required.
C. Claim 32 is indefinite because the EU GMP for medicinal products is a guideline that gets updated; thus, it is unclear what the metes and bounds of the claim is because it is unclear which version the claim refers to.
D. Claim 43 is indefinite in the recitation “ selected from the group consisting of a manufacturing device (10) comprising a process medial supply unit and a mixing unit,” as it is unclear if the supply unit and mixing unit are alternative embodiments of the Markush group.
9. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
10. Claim 29 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 29 recites no further structural limitations that differentiate the instantly claimed manufacturing device from the device of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102/103
11. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
12. 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.
13. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
14. Claims 1-3, 8, 10, and 29-30 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Kawai (U.S. Patent Application Publication No. US 2004/0076952 A1, published 22 April 2004).
Regarding claim 1, Kawai teaches a device comprising tubing that is wound from first compartment (i.e., isothermal tank 2) to a second compartment (i.e., thermal tank 3) to form a helical stack of tubing Figure 1), wherein each isothermal tank maintains a temperature for denaturing (i.e., tank 2) and annealing (i.e., tank 3; paragraphs 0031-0033 and Figure 1).
Alternatively, the courts have found that changes in shape are obvious (In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)). Thus, the claimed helical stack is an obvious variant of Kawai. See MPEP 2144.04 IV B.
MPEP 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)). Thus, counsel’s mere arguments cannot take the place of evidence in the record.
Regarding claims 2-3, the device of claim 1 is discussed above. Kawai teaches a third elongation chamber (i.e., extension tank 4; paragraph 0032 and Figure 1), and that the tube is wound through the first, second, and third compartments (i.e., tanks 2, 3, and 4) and back to the first compartment (i.e., tanks 2; Figure 1).
Regarding claim 8, the device of claim 1 is discussed above.
It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter shown to be in the prior art does not possess the characteristic relied on” (205 USPQ 594, second column, first full paragraph).
In the instant case, Kawai teaches the compartments are within container bodies (paragraph 0032), which are shown to comprise walls (Figure 1), which are interpreted as the claimed septum walls.
Applicant is again cautioned to not merely rely upon counsel’s arguments in place of evidence in the record.
Regarding claim 10, the device of claim 1 is discussed above. Kawai teaches each compartment comprises a heater 9 (Figure 1 and paragraph 0033).
Regarding claim 29, the device of claim 1 is discussed above. Because the claim contains no further structural limitations, the limitations of claim 1 are sufficient for the instant claim.
Regarding claim 30, the device of claim 29 is discussed above. Kawai teaches process chamber 5, which is a process chamber because wet processes (i.e., reaction solutions) are held therein (Figure 1 and paragraphs 0031-0033), as discussed on page 13 of the instant specification. Thus, the claim has been given the broadest reasonable interpretation consistent with the teachings of the specification (In re Hyatt, 211 F.3d1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000) (see MPEP 2111).
In addition, it is reiterated that apparatus claims cover what a device is, not what a device does. Therefore, the various uses recited in the claims (e.g., preparing a DNA product, guiding a PCR liquid, etc.) fail to define additional structural elements of the claimed device. Because the cited prior art teaches the structural elements of the claim, the claim is anticipated by, or obvious over, Kawai.
15. Claims 1-5, 10, and 29 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Griffin (US. Patent Application Publication No. US 2012/0034688 A1, published 9 February 2012).
Regarding claim 1, Griffin teaches a device comprising a tube, in the form of a helical channel (i.e., HCM; Abstract and paragraph 0039), wherein the tube is would from a first compartment to a second compartment; i.e., the HCM is mounted within heat zone blocks (paragraph 0041 and Figure 7). Each compartment (i.e., heat block zone) is held at a different temperature, including those for denaturation and annealing (paragraph 0035).
Regarding claims 2-3, the device of claim 1 is discussed above. Griffin teaches the device further comprises a third compartment (i.e., heating block) for elongation (i.e., claim 2; paragraph 0035), and that the tube (i.e., HCM) is continuously wound from the first to the second to the third compartments after looping back from the third to the first compartment to repeat a temperature cycle (paragraph 0037).
Regarding claim 4, the device of claim 1 is discussed above. Griffin teaches each tube winding is one PCR cycle (paragraphs 0032-0033).
Regarding claim 5, the device of claim 1 is discussed above. Griffin teaches inlets and outlets (paragraph 0040), including those for reagents and product removal (paragraph 0051).
In addition, regarding claims 4-5, it is reiterated that the courts have held that apparatus claims cover what a device is, not what a device does. Therefore, the various uses recited in the claims (e.g., completing a PCR cycle fail, adding PCR liquid and removing DNA products) fail to define additional structural elements of the claimed device. Because the cited prior art teaches the structural elements of the claim, the claim is anticipated by, or obvious over, Griffin.
Regarding claim 10, the device of claim is discussed above. Griffin also teaches each compartment comprising a heating unit to adjust the temperature in each compartment; i.e., each compartment is a heating block (paragraph 0022).
Regarding claim 29, the device of claim 1 is discussed above. Because the claim contains no further structural limitations, the limitations of claim 1 are sufficient for the instant claim.
Claim Rejections - 35 USC § 103
16. Claims 1, 4-7, 29-30, and 43 are rejected under 35 U.S.C. 103 as obvious over Kawai (U.S. Patent Application Publication No. US 2004/0076952 A1, published 22 April 2004) in combination with Griffin (US. Patent Application Publication No. US 2012/0034688 A1, published 9 February 2012).
It is noted that this rejection applies to claims 1, 5, and 29 to the extent that they are drawn to the embodiments of dependent claims 4, 6-7, 30, and 43.
Regarding claims 4 and 43, Kawai teaches the devices of claims 1 and 29 as discussed above in Section 14.
Griffin teaches each tube winding is one PCR cycle (i.e., claim 4; paragraphs 0032-0033) and that the device is compatible with post amplification purification Claim 1of Griffin); thus, it would have been obvious to include a manufacturing device comprising a purification unit (i.e., claim 43). Griffin also teaches the devices have the added advantage of allowing monitoring of amplification and detection of specific products (Abstract). Thus, Griffin teaches the known techniques discussed above.
Regarding claims 6-7 and 30, Griffin teaches the devices of claims 1, 5, and 29 as discussed above in Section 15.
Kawai teaches the inlet is connected to pump 7 (i.e., claim 6; Figure 3 and paragraph 0038) and that the outlet is for continuous sample preparation (i.e., claim 7; paragraph 0038).
Kawai further teaches process chamber 5, which is a process chamber because wet processes (i.e., reaction solutions) are held therein (i.e., claim 30; Figure 1 and paragraphs 0031-0033), as discussed on page 13 of the instant specification. Thus, the claim has been given the broadest reasonable interpretation consistent with the teachings of the specification.
In addition, it is reiterated that apparatus claims cover what a device is, not what a device does. Therefore, the various uses recited in the claims fail to define additional structural elements of the claimed device. Because the cited prior art teaches the structural elements of the claim, the claims are obvious.
Kawai also teaches the devices have the added advantage of improved amplification efficiency (Abstract). Thus, Kawai teaches the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Kawai and Griffin to arrive at the instantly claimed device with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in the devices of Kawai having the added advantage of allowing monitoring of amplification and detection of specific products as explicitly taught by Griffin (Abstract) or the devices of Griffin having the added advantage of improved amplification efficiency as explicitly taught by Kawai (Abstract). In addition, it would have been obvious to the ordinary artisan that the known techniques of Kawai and Griffin could have been combined with predictable results because the known techniques of Kawai and Griffin predictably result in reliable modifications useful for nucleic acid amplification.
17. Claims 1 and 5-7 are rejected under 35 U.S.C. 103 as obvious over Kawai (U.S. Patent Application Publication No. US 2004/0076952 A1, published 22 April 2004).
It is noted that this rejection applies to claim 1 to the extent that it is drawn to the embodiments of dependent claims 5-7.
Regarding claim 5, the device of claim 1 is discussed above in Section 14.
Kawai also teaches an liquid inlet and an outlet from which a product can be removed (paragraph 0038 and Figure 3).
Regarding claim 6, the device of claim 5 is discussed above. Kawai also teaches the inlet is connected to pump 7 (Figure 3 and paragraph 0038).
Regarding claim 7, the device of claim 5 is discussed above. Kawai teaches the outlet is for continuous sample preparation (paragraph 0038).
Thus, Kawai teaches all of the claimed limitations, and the claims are obvious.
18. Claims 1 and 8-9 are rejected under 35 U.S.C. 103 as obvious over Kawai (U.S. Patent Application Publication No. US 2004/0076952 A1, published 22 April 2004) in view of Curcio et al. (Anal. Chem., vol. 75, pages 1-7, published online 28 November 2002).
It is noted that this rejection applies to claims 1 and 8 to the extent that they are drawn to the embodiments of dependent claim 9.
Regarding claim 9, the devices of claim 1 and 8 are discussed above in Section 14.
Kawai does not teach walls comprising holes.
However, Curcio et al. teach a PCR device comprising a sample tube for amplification that passes through holes in the walls of PCR temperature zones (Figure 1 and page 3, column 1), which has the added advantage of allowing rapid miniaturized amplification (“Conclusions”). Thus, Curcio et al. teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device taught by Kawai with the teachings of Curcio et al. to arrive at the instantly claimed device with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have resulted in a device having the added advantage of allowing rapid miniaturized amplification as explicitly taught by Curcio et al. (“Conclusions”). In addition, it would have been obvious to the ordinary artisan that the known techniques of Curcio et al. could have been applied to the device of Kawai with predictable results because the known techniques of Curcio et al. predictably result in reliable temperature control during amplification.
19. Claims 1 and 11-14 are rejected under 35 U.S.C. 103 as obvious over Kawai (U.S. Patent Application Publication No. US 2004/0076952 A1, published 22 April 2004) in view of Belgrader et al. (U.S. Patent Application Publication No. US 2011/0207180 A1, published 25 August 2011).
It is noted that this rejection applies to claim 1 to the extent that it is drawn to the embodiments of dependent claims 11-14.
Regarding claim 11, the device of claim 1 is discussed above in Section 14.
Kawai does not teach the compartments are heated with thermal medium delivered via inlets or outlets.
However, Belgrader et al. teach devices for performing PCR (paragraph 0036) comprising reaction chambers flanked by temperature bladders having thermal media therein, wherein the thermal media (i.e., temperature control fluid) is pumped through inlets and outlets (Figure 2 and paragraph 0035), which has the added advantage of providing efficient heat transfer (paragraph 0036). Thus, Belgrader et al. tech the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device taught by Kawai with the teachings of Belgrader et al. to arrive at the instantly claimed device with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have resulted in a device having the added advantage of providing efficient heat transfer as explicitly taught by Belgrader et al. (paragraph 0036). In addition, it would have been obvious to the ordinary artisan that the known techniques of Belgrader et al. could have been applied to the device of Kawai with predictable results because the known techniques of Belgrader et al. predictably result in reliable temperature control during amplification.
Regarding claims 12-13, the device of claim 11 is discussed above.
It is noted that the courts have held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device (In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)). See MPEP §2144.04.
The courts have found that “where 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 II.
Thus, the flow direction of claim 12 and the arrangement of the inlets and outlets of claim 13 merely represents routine rearrangement and/or optimization of the placement of the inlet and outlets for fluid flow.
Applicant is again cautioned to not merely rely upon counsel’s arguments in place of evidence in the record.
Regarding claim 14, the device of claim 11 is discussed above.
It is reiterated that the courts have found that changes in shape are obvious. Thus, the corrugated manner is an obvious variant of the teachings of the cited prior art.
Applicant is again cautioned to not merely rely upon counsel’s arguments in place of evidence in the record.
20. Claims 1 and 29-31 are rejected under 35 U.S.C. 103 as obvious over Kawai (U.S. Patent Application Publication No. US 2004/0076952 A1, published 22 April 2004) in view of Egan et al. (U.S. Patent Application Publication No. Us 2014/0295441 A1, published 2 October 2014).
It is noted that this rejection applies to claims 1 and 29-30 to the extent that they are drawn to the embodiments of dependent claim 31.
Regarding claim 31, the devices of claims 1 and 29-30 are discussed above in Section 14.
It is noted that page 14 of the instant specification discussed a gas shower as being provided by a pump, and provides no limiting definition of the claimed control unit.
While Kawai teaches a control unit, in the form of control circuitry (paragraph 0032), gas showers (i.e. blowing of air; paragraph 0021), and a pump (Abstract), Kawai does not teach a gas shower in the processing (i.e., mixing) chamber.
However, Egan et al. teach a control unit, in the form of a controller module for provide pressure or vacuum (paragraph 0028) as well as gas shower, in the form of laminar flow of gas in a PCR process (i.e., mixing) chamber (paragraph 0055); the laminar gas flow is a gas shower in accordance with page 14 of the instant specification. Thus, the claim has been given the broadest reasonable interpretation consistent with the teachings of the specification. Egan et al. also teach the controller module has the added advantage of controlling hydrodynamic movement (paragraph 0028). Thus, Egan et al. teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device taught by Kawai with the teachings of Egan et al. to arrive at the instantly claimed device with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have resulted in a device having the added advantage of controlling hydrodynamic movement as explicitly taught by Egan et al. (paragraph 0028). In addition, it would have been obvious to the ordinary artisan that the known techniques of Egan et al. could have been applied to the device of Kawai with predictable results because the known techniques of Egan et al. predictably result in reliable flow control.
21. Claims 1, 29-30, and 32 are rejected under 35 U.S.C. 103 as obvious over Kawai (U.S. Patent Application Publication No. US 2004/0076952 A1, published 22 April 2004) in view of Kakiuchi et al. (U.S. patent Application Publication No. US 2015/0041498 A1, published 12 February 2018).
It is noted that this rejection applies to claims 1 and 29-30 to the extent that they are drawn to the embodiments of dependent claim 32.
Regarding claim 32, the devices of claims 1 and 29-30 are discussed above in Section 14.
While Kawai teaches the desire to prevent contamination (paragraph 0063), Kawai does not teach the EU guidelines.
However, Kakiuchi et al. teach the EU guideline governs medicinal products for human and veterinary use for providing sterile products (paragraph 0038). Thus, Kakiuchi et al. teach the known techniques discussed above.
In addition, it is reiterated that he courts have found that “where 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.
Thus, using he EU guidelines as a benchmark for sterility, so as to minimize contamination as desired by Kawai, merely represents routine optimization of the minimization of contamination.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device taught by Kawai with the teachings of Kakiuchi et al. to arrive at the instantly claimed device with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have resulted in a device having the added advantage of being sterile as explicitly taught by Kakiuchi et al. (paragraph 0038). In addition, it would have been obvious to the ordinary artisan that the known techniques of Kakiuchi et al. could have been applied to the device of Kawai with predictable results because the known techniques of Kakiuchi et al. predictably result in a sterile, and thus un-contaminated, device.
22. Claims 1, 8, 29, and 43 are rejected under 35 U.S.C. 103 as obvious over Griffin (US. Patent Application Publication No. US 2012/0034688 A1, published 9 February 2012).
It is noted that this rejection applies to claims 1 and 29 to the extent that they are drawn to the embodiments of dependent claims 8 and 43.
Regarding claims 8 and 43, the devices of claims 1 and 29 are discussed above in Section 15.
Griffin teaches a septum wall, in the form of an insulating barrier that defines three thermal PCR zones (paragraph 0044).
It is noted that the courts have held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144.04 VI.B. Thus, having multiple walls of claim 8 is an obvious variant of the wall (i.e., insulation barrier) of Griffin.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record.
Griffin also teaches the device is compatible with post amplification purification Claim 1of Griffin); thus, it would have been obvious to include a manufacturing device comprising a purification unit (i.e., claim 43).
Thus, Griffin teaches all of the claimed limitations, and the claims are obvious.
23. Claim 9 is rejected under 35 U.S.C. 103 as obvious over Griffin (US. Patent Application Publication No. US 2012/0034688 A1, published 9 February 2012) as applied to claim 8 above, and further in view of Curcio et al. (Anal. Chem., vol. 75, pages 1-7, published online 28 November 2002).
Regarding claim 9, the device of claim 8 is discussed above in Section 22.
Griffin does not teach walls comprising holes.
However, Curcio et al. teach a PCR device comprising a sample tube for amplification that passes through holes in the walls of PCR temperature zones (Figure 1 and page 3, column 1), which has the added advantage of allowing rapid miniaturized amplification (“Conclusions”). Thus, Curcio et al. teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device taught by Griffin with the teachings of Curcio et al. to arrive at the instantly claimed device with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have resulted in a device having the added advantage of allowing rapid miniaturized amplification as explicitly taught by Curcio et al. (“Conclusions”). In addition, it would have been obvious to the ordinary artisan that the known techniques of Curcio et al. could have been applied to the device of Griffin with predictable results because the known techniques of Curcio et al. predictably result in reliable temperature control during amplification.
24. Claims 1 and 11-14 are rejected under 35 U.S.C. 103 as obvious over Griffin (US. Patent Application Publication No. US 2012/0034688 A1, published 9 February 2012) in view of Belgrader et al. (U.S. Patent Application Publication No. US 2011/0207180 A1, published 25 August 2011).
It is noted that this rejection applies to claim 1 to the extent that it is drawn to the embodiments of dependent claims 11-14.
Regarding claim 11, the device of claim 1 is discussed above in Section 15.
Griffin does not teach the compartments are heated with thermal medium delivered via inlets or outlets.
However, Belgrader et al. teach devices for performing PCR (paragraph 0036) comprising reaction chambers flanked by temperature bladders having thermal media therein, wherein the thermal media (i.e., temperature control fluid) is pumped through inlets and outlets (Figure 2 and paragraph 0035), which has the added advantage of providing efficient heat transfer (paragraph 0036). Thus, Belgrader et al. tech the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device taught by Griffin with the teachings of Belgrader et al. to arrive at the instantly claimed device with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have resulted in a device having the added advantage of providing efficient heat transfer as explicitly taught by Belgrader et al. (paragraph 0036). In addition, it would have been obvious to the ordinary artisan that the known techniques of Belgrader et al. could have been applied to the device of Griffin with predictable results because the known techniques of Belgrader et al. predictably result in reliable temperature control during amplification.
Regarding claims 12-13, the device of claim 11 is discussed above.
It is reiterated that the courts have held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device, and that where 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.
Thus, the flow direction of claim 12 and the arrangement of the inlets and outlets of claim 13 merely represents routine rearrangement and/or optimization of the placement of the inlet and outlets for fluid flow.
Applicant is again cautioned to not merely rely upon counsel’s arguments in place of evidence in the record.
Regarding claim 14, the device of claim 11 is discussed above.
It is reiterated that the courts have found that changes in shape are obvious. Thus, the corrugated manner is an obvious variant of the teachings of the cited prior art.
Applicant is again cautioned to not merely rely upon counsel’s arguments in place of evidence in the record.
25. Claim 31 is rejected under 35 U.S.C. 103 as obvious over Griffin (US. Patent Application Publication No. US 2012/0034688 A1, published 9 February 2012) and Kawai (U.S. Patent Application Publication No. US 2004/0076952 A1, published 22 April 2004) as applied to claim 30 above, and further in view of Egan et al. (U.S. Patent Application Publication No. Us 2014/0295441 A1, published 2 October 2014).
Regarding claim 31, the devices of claim 30 is discussed above in Section 16.
It is reiterated that page 14 of the instant specification discussed a gas shower as being provided by a pump, and provides no limiting definition of the claimed control unit.
While Kawai teaches a control unit, in the form of control circuitry (paragraph 0032), gas showers (i.e. blowing of air; paragraph 0021), and a pump (Abstract), neither Griffin nor Kawai teaches a gas shower in the processing (i.e., mixing) chamber.
However, Egan et al. teach a control unit, in the form of a controller module for provide pressure or vacuum (paragraph 0028) as well as gas shower, in the form of laminar flow of gas in a PCR process (i.e., mixing) chamber (paragraph 0055); the laminar gas flow is a gas shower in accordance with page 14 of the instant specification. Thus, the claim has been given the broadest reasonable interpretation consistent with the teachings of the specification. Egan et al. also teach the controller module has the added advantage of controlling hydrodynamic movement (paragraph 0028). Thus, Egan et al. teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device taught by Griffin and Kawai with the teachings of Egan et al. to arrive at the instantly claimed device with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have resulted in a device having the added advantage of controlling hydrodynamic movement as explicitly taught by Egan et al. (paragraph 0028). In addition, it would have been obvious to the ordinary artisan that the known techniques of Egan et al. could have been applied to the device of Griffin and Kawai with predictable results because the known techniques of Egan et al. predictably result in reliable flow control.
26. Claim 32 is rejected under 35 U.S.C. 103 as obvious over Griffin (US. Patent Application Publication No. US 2012/0034688 A1, published 9 February 2012) and Kawai (U.S. Patent Application Publication No. US 2004/0076952 A1, published 22 April 2004) as applied to claim 30 above, and further in view of Kakiuchi et al. (U.S. patent Application Publication No. US 2015/0041498 A1, published 12 February 2018).
Regarding claim 32, the device of claim 30 is discussed above in Section 16.
While Kawai teaches the desire to prevent contamination (paragraph 0063), neither Griffin nor Kawai teaches the EU guidelines.
However, Kakiuchi et al. teach the EU guideline governs medicinal products for human and veterinary use for providing sterile products (paragraph 0038). Thus, Kakiuchi et al. teach the known techniques discussed above.
In addition, it is reiterated that he courts have found that “where 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.
Thus, using he EU guidelines as a benchmark for sterility, so as to minimize contamination as desired by Kawai, merely represents routine optimization of the minimization of contamination.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device taught by Griffin and Kawai with the teachings of Kakiuchi et al. to arrive at the instantly claimed device with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have resulted in a device having the added advantage of being sterile as explicitly taught by Kakiuchi et al. (paragraph 0038). In addition, it would have been obvious to the ordinary artisan that the known techniques of Kakiuchi et al. could have been applied to the device of Griffin and Kawai with predictable results because the known techniques of Kakiuchi et al. predictably result in a sterile, and thus un-contaminated, device.
Conclusion
27. No claim is allowed.
28. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert T. Crow whose telephone number is (571)272-1113. The examiner can normally be reached M-F 8:00-4:30.
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Robert T. Crow
Primary Examiner
Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683
Prosecution Insights