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 .
Preliminary Amendment, Non-Compliant Amendments, and Status of the Claims
2. The preliminary amendment filed 4 November 2024, in which claims 1-3 were cancelled and new claims 4-23 were added, is acknowledged and entered.
However, the preliminary amendment filed 4 November 2024 fails to comply with 37 CFR 1.121 for the following reason(s): claim 23 contains an underscore indicating change, but claim 23 is a new claim and should not have any amendments.
It is emphasized that Applicant’s preliminary amendment has been considered in the interest of customer service and compact prosecution. However, for the response to this Office Action to be complete, Applicant is REQUIRED to file amendments that are compliant with 37 CFR 1.121. Failure to comply with this requirement will be considered nonresponsive.
Claims 4-23 are under prosecution.
Information Disclosure Statement
3. The Information Disclosure Statements filed 16 July 2024, 10 October 2024, 13 January 2025, 25 April 2025, and 25 July 2025 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.
Specification
4. The use of trade names or marks used in commerce (including but not necessarily limited to Triton and Tween), 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.
Claim Interpretation
5. The claims are subject to the following interpretation:
A. Claims 4-23 are drawn to a “system.” The specification recites a “system” wherein the “system” is defined in terms of structural limitations. In addition, the claims recite structural limitations of the “system.” Thus, the “system” is interpreted to encompass any collection of reagents and parts used together that are not necessarily part of a completely integrated single unitary device. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation on the claimed subject matter.
B. Claims 14-15 each refer to a “dropped side” of the first substrate. Based on Figures 17A-E of the instant specification, the claimed “dropped side” refers to a side of a substrate that has a drop of fluid place thereon (i.e., as opposed to a slide that is “dropped” from a higher position to a lower position).
Claim Rejections - 35 USC § 112
6. 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.
7. Claims 23 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.
Claim 23 is indefinite in the recitation “[t]he method of claim 4,” as claim 4 is drawn to a system, not a method.
In addition, because the claim recites a method, it is unclear if the phrase “is disposed” is intended to claim an active method step.
Further, it is unclear how the spacer can surround the chamber to maintain the fluid within the chamber when claim 4, upon which claim 23 depends, requires the reservoir to have an opening to receive the fluid; i.e., the spacer appears to be open to both the reservoir and the chamber, and thus cannot surround the chamber.
Claim Rejections - 35 USC § 103
8. 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.
9. 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.
10. Claims 4-10, 12-13, 18, and 21 are rejected under 35 U.S.C. 103 as obvious over Meisner et al. (U.S. Patent Application Publication No. US 2009/0068667 A1, published 12 March 2009) and Bort et al. (U.S. Patent Application Publication No. US 2017/0241949 A1, published 24 August 2017).
Regarding claim 4, Meisner et al. teach systems (paragraph 0009) comprising a first substrate, in the form of an ESC slide, and a second substrate comprising an array, in the form of a substrate slide an array of labeled probes thereon (Figure 2). Meisner et al. further teach a spacer, in the form of a gasket, which is fabricated on either the first or second slide (i.e., delivery platform; paragraphs 0130 and 0126).
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, the spacer (i.e., gasket) seals the delivery surface (paragraph 0130), thereby forming a sealed hybridization chamber that maintains (i.e., seals and encloses) the fluid therein, maintaining a separation distance between the two substrates (i.e., slides; paragraph 0130 and Figure 2).
Meisner et al. teach the systems have the added advantage of providing a rapid and sensitive platform for detecting high and low levels of chromosomal aberrations in a cell population (Abstract). Thus, Meisner et al. teach the known techniques discussed above.
Meisner et al. do not teach the gasket comprises a reservoir.
However, Bort et al. teach systems (paragraph 0021) comprising first substrate 110 having array 124 thereon and second substrate 112 separated by gasket 114 (Figure 1), wherein gasket 114 comprises a over array 124 and a plurality of reservoirs 132a-4, each of which have openings to receive fluid, in the form of either open tops that align with input ports 134 or the openings to the channel between reservoir 126 and the chamber above array 124 (Figure 1 and paragraphs 0069-0076). Bort et al. also teach the system has the added advantage of allowing dispensing of sample fluids (paragraph 0072). Thus, Bort 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 combined the teachings of Meisner et al. and Bort et al. to arrive at the instantly claimed system with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a system having the added advantages of providing a rapid and sensitive platform for detecting high and low levels of chromosomal aberrations in a cell population as explicitly taught by Meisner et al. (Abstract) and allowing dispensing of sample fluids as explicitly taught by Bort et al. (paragraph 0072). In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been combined with predictable results because the known techniques of the cited prior art predictably result in systems useful for microfluidic assays.
Regarding claims 5-6, the system of claim 4 is discussed above. Meisner et al. teach the substrates and spacer fully encompass the volume comprising the biological sample (i.e., claim 5) because the gasket is provided on the perimeter of both slides (i.e., delivery platforms) and seals the chamber (i.e., claim 6; paragraph 0130).
Regarding claims 7-8, the system of claim 4 is discussed above. Bort et al. teach the thickness of the gasket sets the height of the gap (paragraph 0072), and that the gasket (i.e., spacer) has a height of 5 microns (paragraph 0014).
It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01).
The courts have also 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.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Applicant is advised that 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, Applicant should not merely rely upon counsel’s arguments in place of evidence in the record.
Regarding claims 9-10, the system of claim 4 is discussed above. Meisner et al. further teach a spacer (i.e., gasket) is fabricated on either the first or second slide (i.e., delivery platform; paragraphs 0130 and 0126).
Regarding claims 12-13, the system of claim 4 is discussed above. Because the instant claims limit the fluid, which is not actually part of the claimed system, the instant limitations do not further limit the system.
Regarding claim 18, the system of claim 4 is discussed above. Meisner et al. further teach a spacer (i.e., gasket) is fabricated on the second slide (i.e., delivery platform; paragraphs 0130 and 0126).
With respect to a printed spacer, the courts have stated:
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 .
See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985), and MPEP§ 2113.
While the cited prior art does not specifically teach printing the spacer, this limitation is part of the process of making the gasket rather than a structural limitation of the gasket. Because the prior art teaches the structural elements of the claim, the claim is obvious.
Applicant is again cautioned against merely relying upon counsel’s arguments in place of evidence in the record.
Regarding claim 21, the system of claim 4 is discussed above. Because the instant claim limits the biological fluid, which is not actually part of the claimed system, the instant limitations do not further limit the system.
In addition, Meisner et al. teach the sample is a tissue sample (paragraph 0029).
11. Claim 11 is rejected under 35 U.S.C. 103 as obvious over Meisner et al. (U.S. Patent Application Publication No. US 2009/0068667 A1, published 12 March 2009) and Bort et al. (U.S. Patent Application Publication No. US 2017/0241949 A1, published 24 August 2017) as applied to claim 4 above, alternatively further in combination with Hu et al. (U.S. Patent Application Publication No. US 2004/0248287 A1, published 9 December 2004).
Regarding claim 11, the system of claim 4 is discussed above in Section 10. Bort et al. teach hydrophilic regions are provided on surfaces (paragraph 0016).
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. Thus, the placement of a hydrophilic coating anywhere within the system is an obvious rearrangement of the components taught by the prior art.
Applicant is again cautioned against merely relying upon counsel’s arguments in place of evidence in the record.
Alternatively, Hu et al. teach systems utilizing biomolecule arrays in chambers formed by two substrates (i.e., slides), wherein the substrates (i.e., slides) are coated with a hydrophilic polymer (paragraph 0042), and that the systems have the added advantage of performing assays with minimal sample volume (Abstract). Thus, Hu et al. teach the known techniques discussed above.
It would therefore have alternatively 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 Hu et al. with the previously cited prior art to arrive at the instantly claimed system with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a system having the added advantage of allowing assays to be performed with minimal sample volume as explicitly taught by Hu et al. (Abstract). In addition, it would have been obvious to the ordinary artisan that the known techniques of Hu et al. could have been combined with the previously cited prior art predictable results because the known techniques of Hu et al. predictably result in materials useful for forming fluidic chambers.
12. Claims 14-15 are rejected under 35 U.S.C. 103 as obvious over Meisner et al. (U.S. Patent Application Publication No. US 2009/0068667 A1, published 12 March 2009) and Bort et al. (U.S. Patent Application Publication No. US 2017/0241949 A1, published 24 August 2017) as applied to claim 4 above, and further in combination with Anderson et al. (U.S. Patent Application Publication No. Us 2002/0022261 A1, published 21 February 2002).
Regarding claim 14, the system of claim 4 is discussed above in Section 10.
While Meisner et al. teach a dropped substrate, in the form of the sample substrate having a drop of fluid added thereon, after with the second substrate is placed thereon (Figure 2), the previously cited art does not teach angling the substrates.
However, Anderson et al. teach systems wherein a second substrate, in the form of a probe array 4912, is placed above a first substrate (i.e., plate 4922) at an angle so that tilting first substrate 4922 spreads a hybridization fluid out across the probe array, which has the added advantage of allowing mixing of the fluid in a very low volume hybridization system (paragraph 0321). Thus, Anderson et al. teach the known techniques discussed above.
It is reiterated that 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.
Thus, the claimed threshold distance and orthogonal axis merely represents routine optimization of the angle at which the claimed fluid urging is initiated.
Applicant is again cautioned against merely relying upon counsel’s arguments in place of evidence in the record.
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 Anderson et al. with the previously cited prior art to arrive at the instantly claimed system with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a system having the added advantage of allowing mixing of the fluid in a very low volume hybridization system as explicitly taught by Anderson et al. (paragraph 0321). In addition, it would have been obvious to the ordinary artisan that the known techniques of Anderson et al. could have been combined with the previously cited prior art predictable results because the known techniques of Anderson et al. predictably result in positions of the materials in a manner useful for contacting liquids within fluidic chambers.
Regarding claim 15, the system of claim 14 is discussed above.
It is noted that the subject matter of a properly construed claim is defined by the terms that limit its scope. It is this subject matter that must be examined. As a general matter, the grammar and intended meaning of terms used in a claim will dictate whether the language limits the claim scope. Language that suggests or makes optional but does not require steps to be performed or does not limit a claim to a particular structure does not limit the scope of a claim or claim limitation. “Wherein” clauses are examples of language that may raise a question as to the limiting effect of the language in a claim. See MPEP 2103 I.C. and MPEP § 2111.04.
Applicant is again cautioned against merely relying upon counsel’s arguments in place of evidence in the record.
13. Claims 16 and 23 rejected under 35 U.S.C. 103 as obvious over Meisner et al. (U.S. Patent Application Publication No. US 2009/0068667 A1, published 12 March 2009) and Bort et al. (U.S. Patent Application Publication No. US 2017/0241949 A1, published 24 August 2017) as applied to claim 4 above, alternatively further in combination with Shah (U.S. Patent Application Publication No. Us 2003/0186250 A1, published 2 October 2003).
Regarding claims 16 and 23, the system of claim 4 is discussed above in Section 10.
Bort et al. teach hydrophobic layers provided on the bottom substrate (paragraph 0013).
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. Thus, the placement of a hydrophobic coating anywhere within the system is an obvious rearrangement of the components taught by the prior art.
Applicant is again cautioned against merely relying upon counsel’s arguments in place of evidence in the record.
Alternatively, Shah teaches arrays of nucleic acids (paragraph 0027), wherein the array is on a substrate and is surrounded by a hydrophobic barrier, which has the added advantage of allowing multiple arrays on the substrate to be contacted at the same times with different samples without the samples mixing (i.e., claim 16; paragraph 0026). Because the arrays do not allow sample mixing, each array chamber is surrounded so that fluid is maintained herein (i.e., claim 23). Thus, Shah teaches the known techniques discussed above.
It would therefore have alternatively 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 Shah with the previously cited prior art to arrive at the instantly claimed systems with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in systems having the added advantage of allowing multiple arrays on the substrate to be contacted at the same times with different samples without the samples mixing as explicitly taught by Shah (paragraph 0026). In addition, it would have been obvious to the ordinary artisan that the known techniques of Shah could have been combined with the previously cited prior art predictable results because the known techniques of Shah predictably result in materials useful for array based assays.
14. Claim 17 is rejected under 35 U.S.C. 103 as obvious over Meisner et al. (U.S. Patent Application Publication No. US 2009/0068667 A1, published 12 March 2009) and Bort et al. (U.S. Patent Application Publication No. US 2017/0241949 A1, published 24 August 2017) as applied to claim 4 above, and further in combination with Besemer et al. (U.S. Patent Application Publication No. US 2005/0106617 A1, published 19 May 2005).
Regarding claim 17, the system of claim 4 is discussed above in Section 10.
The previously cited art does not teach uniform thickness of the spacer.
However, Besemer et al. teach devices comprising hybridization chambers (paragraph 0007) having gaskets of uniform thickness (claims 103 and 142 of Besemer et al), and that the devices have the added advantage of providing a practical medium for sequencing by hybridization (paragraph 0007). Thus, Besemer et al. teach the known techniques discussed above.
It is also noted that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists, 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.
Therefore, the claimed “uniform” thickness merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Applicant is again cautioned against merely relying upon counsel’s arguments in place of evidence in the record.
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 Besemer et al. with the previously cited prior art to arrive at the instantly claimed system with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a system having the added advantage of providing a practical medium for sequencing by hybridization as explicitly taught by Besemer et al. (paragraph 0007). In addition, it would have been obvious to the ordinary artisan that the known techniques of Besemer et al. could have been combined with the previously cited prior art predictable results because the known techniques of Besmer et al. predictably result in materials useful for formation of fluidic chambers.
15. Claims 18-19 are rejected under 35 U.S.C. 103 as obvious over Meisner et al. (U.S. Patent Application Publication No. US 2009/0068667 A1, published 12 March 2009) and Bort et al. (U.S. Patent Application Publication No. US 2017/0241949 A1, published 24 August 2017) as applied to claim 4 above, and further in combination with Rey-Mermet (U.S. Patent Application Publication No. US 2008/0218838 A1, published 11 September 2008).
It is noted that while claim 18 is rejected as described above, the claim is also obvious using the interpretation outlined below.
Regarding claims 18-19, the system of claim 4 is discussed above in Section 10.
The previously cited prior art does not teach gaskets that are printed (i.e., claim 18) or comprise a photoresist pattern (i.e., claim 19).
However, Rey-Mermet teaches systems for retaining fluids between two substrates (Figure 3 and paragraph 0045) and which utilize spacer walls patterned from photoresist (i.e., claim 19; paragraph 0061). Rey-Mermet also teaches printing of the spacer walls (i.e., claim 18; paragraph 0031), and the added advantage of allowing the use of surface micromachining steps (paragraph 0070). Thus, Rey-Mermet 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 Rey-Mermet with the previously cited prior art to arrive at the instantly claimed systems with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in systems having the added advantage of allowing the use of surface micromachining steps as explicitly taught by Rey-Mermet (paragraph 0070). In addition, it would have been obvious to the ordinary artisan that the known techniques of Rey-Mermet could have been combined with the previously cited prior art predictable results because the known techniques of Rey-Mermet predictably result in materials useful for formation of fluidic chambers.
16. Claim 20 is rejected under 35 U.S.C. 103 as obvious over Meisner et al. (U.S. Patent Application Publication No. US 2009/0068667 A1, published 12 March 2009) and Bort et al. (U.S. Patent Application Publication No. US 2017/0241949 A1, published 24 August 2017) as applied to claim 4 above, and further in combination with Peter et al. (U.S. Patent Application Publication No. US 2015/0148239 A1, published 28 May 2015).
Regarding claim 20, the system of claim 4 is discussed above in Section 10.
While Meisner et al. teach arrays of probes for capturing (i.e., binding) DNA at discrete features (i.e., locations) on an array (paragraph 0008-0011), the previously cited prior art does not teach barcodes.
However, Peter et al. teach substrates comprising arrays (paragraph 0037) wherein spatial barcodes (Abstract) are provided on capture probes (paragraph 0091), and that the spatial barcodes have the added advantage of allowing color coding so that the binding locations can be distinguished from each other by eye (paragraph 0062). Thus, Peter 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 combined the teachings of Peter et al. with the previously cited prior art to arrive at the instantly claimed system with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a system having the added advantage of allowing color coding so that the binding locations can be distinguished from each other by eye as explicitly taught by Peter et al (paragraph 0062). In addition, it would have been obvious to the ordinary artisan that the known techniques of Peter et al. could have been combined with the previously cited prior art predictable results because the known techniques of Peter et al. predictably result in useful capture probes.
17. Claim 22 is rejected under 35 U.S.C. 103 as obvious over Meisner et al. (U.S. Patent Application Publication No. US 2009/0068667 A1, published 12 March 2009) and Bort et al. (U.S. Patent Application Publication No. US 2017/0241949 A1, published 24 August 2017) as applied to claim 4 above, and further in combination with Hu et al. (U.S. Patent Application Publication No. US 2004/0248287 A1, published 9 December 2004).
Regarding claim 22, the system of claim 4 is discussed above in Section 10.
The previously cited prior art does not teach the spacer promotes a contact angle of at least 50 degrees.
However, Hu et al. teach systems utilizing biomolecule arrays in chambers formed by two substrates (i.e., slides), wherein the substrates (i.e., slides) are separated by a gasket made of silicone (paragraph 0073), which has a contact angle of at least 50 degrees as discussed in paragraph 00210 if the instant specification. Thus, the claim has been given the broadest reasonable interpretation consistent with the teachings of the specification regarding a spacer having the claimed contact angle (In re Hyatt, 211 F.3d1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000) (see MPEP 2111).
Hu et al. also teach the systems have the added advantage of providing a better seal (paragraph 0071). Thus, Hu 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 combined the teachings of Hu et al. with the previously cited prior art to arrive at the instantly claimed system with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a system having the added advantage of providing a better seal as explicitly taught by Hu et al. (paragraph 0071). In addition, it would have been obvious to the ordinary artisan that the known techniques of Hu et al. could have been combined with the previously cited prior art predictable results because the known techniques of Hu et al. predictably result in materials useful for forming fluidic chambers.
Double Patenting
18. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
19. Claims 4-10, 12-15, and 17-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,128,403.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to the same substrates, spacers, samples, enclosed volumes, distances, dropped sides, contact angles, etc. any additional limitations of the ‘403 claims are encompassed by the open claim language “comprising” found in the instant claims.
With respect to claim 10, 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. Thus, the placement of a hydrophobic coating anywhere within the system is an obvious rearrangement of the components taught by the prior art.
With respect to claims 12-13, it is reiterated that these limitations are part of the fluid, which is not actually part of the claimed system.
Applicant is again cautioned against merely relying upon counsel’s arguments in place of evidence in the record.
20. Claim 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,128,403 as applied to claim 4 above, and further in combination with Bort et al. (U.S. Patent Application Publication No. US 2017/0241949 A1, published 24 August 2017) and, alternatively further in combination with Hu et al. (U.S. Patent Application Publication No. US 2004/0248287 A1, published 9 December 2004) based on the citations and rationale provided above.
21. Claims 16 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,128,403 as applied to claim 4 above, and further in combination with Bort et al. (U.S. Patent Application Publication No. US 2017/0241949 A1, published 24 August 2017) as applied to claim 4 above, and, alternatively further in combination with Shah (U.S. Patent Application Publication No. Us 2003/0186250 A1, published 2 October 2003) based on the citations and rationale provided above.
22. Claims 4-10 and 12-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12,508,590 in combination with Bort et al. (U.S. Patent Application Publication No. US 2017/0241949 A1, published 24 August 2017).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to the same substrates, spacers, samples, enclosed volumes, distances, dropped sides, contact angles, etc. any additional limitations of the ‘590 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘590 claims do not require the claimed reservoir.
However, the claimed reservoir, as well as the rationale for combining, are taught by Bort et al. as discussed in detail above.
23. Claim 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12,508,590 and Bort et al. (U.S. Patent Application Publication No. US 2017/0241949 A1, published 24 August 2017), and alternatively further in combination with Hu et al. (U.S. Patent Application Publication No. US 2004/0248287 A1, published 9 December 2004) based on the citations and rationale provided above.
24. Claim 23 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12,508,590 and Bort et al. (U.S. Patent Application Publication No. US 2017/0241949 A1, published 24 August 2017) as applied to claim 4 above, and, alternatively further in combination with Shah (U.S. Patent Application Publication No. Us 2003/0186250 A1, published 2 October 2003) based on the citations and rationale provided above.
Conclusion
25. No claim is allowed.
26. 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
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