DETAILED CORRESPONDENCE
Summary
This Office Correspondence is based on the Amendment filed with the Office on 24 June 2026, regarding the Wu, et al. application.
Claims 1-21 are currently pending and have been fully considered.
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 § 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 1-10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over a published paper by A. Klose, et al. (“Identification and discrimination of extracellularly active cathepsins B and L in high-invasive melanoma cells”, Analytical Biochemistry, 353(1): p. 57-62, Jun 2006; hereinafter, “Klose”) in view of a published paper by Y. Rong, et al. (“The Golgi microtubules regulate single cell durotaxis”, EMBO Reports, 22(3): e51094, 14 pages, Mar 2021; hereinafter, “Rong”), and in view of a published paper by X. Wu, et al. (“One-step casting of Laemmli discontinued sodium dodecyl sulfate-polyacrylamide gel electrophoresis gel”, Analytical Biochemistry, 421(1): p. 347-349, Feb 2012; hereinafter, “Wu”).
Regarding claim 1, Klose discloses an electrophoresis gel formulation, as a lithium dodecyl sulfate – polyacrylamide gel electrophoresis gel (“LDS zymography”, p. 58). Klose teaches a resolving gel (termed a “Separation gel”) comprising acrylamide, bisacrylamide, 2,2-bis(hydroxymethyl)-2,2’,2”-nitrilotriehtanol (termed “BisTris”) and riboflavin, useful as a photoinitiator (“LDS zymography”, p. 58). Klose further teaches a stacking gel comprising acrylamide, bisacrylamide, BisTris, and riboflavin (“LDS zymography”, p. 58). Thus, Klose teaches the resolving gel and the stacking gel comprise distinct gel compositions.
Klose teaches riboflavin, rather than lithium phenyl-2,4,6,-trimethylbenzoylphosphinate (LAP), as a photoinitiator.
However, Rong teaches the photoinitiation polymerization of acrylamide gel by use of LAP (“Polyacrylamide gels with stiff island”, p. 11).
At the time of the filing of the present application, it would have been obvious to one of ordinary skill in the art to have made the simple substitution one known element for another by utilizing LAP, taught by Rong, in place of riboflavin disclosed in Klose, with predictable results.
Klose does not explicitly teach wherein the resolving gel and the stacking gel are polymerizable concurrently in a single step.
However, Wu discloses a one-step casting of a Laemmli SDS-PAGE gel containing a separating gel and a stacking gel (2nd ¶, p. 347).
At the time of the filing of the present application, it would have been obvious to one of ordinary skill in the art to have adapted the methodology of one step casting of stacking and resolving gels as it constitutes a saving of time without loss of separation power (Wu, 2nd ¶, p. 347).
As to the amended limitations, “… [the gels] are polymerized concurrently in a single step via activation of the photoinitiators in both the resolving gel and in the stacking gel to initiate polymerization in both gels at the same time”, this is a product-by-process limitation. "[E]ven 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." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted)
Regarding claim 2, Klose teaches the separation gel has an acrylamide:bis-acrylamide weight ratio of 35.7:1 (“LDS zymography”, p. 58).
Regarding claim 3, Klose teaches a separation gel having a total acrylamide concentration of 11% w/v (“LDS zymography”, p. 58).
Regarding claim 4, Klose teaches a BisTris concentration of 300 mM, but teaches a photoinitiator amount of 1% w/v (“LDS zymography”, p. 58).
It would be obvious to one of ordinary skill in the art to have, through routine experimentation, utilized various amounts of photoinitiator so as to optimize the formation of the photopolymerized gel. Thus, the concentration would have been obviously modified, including minimal amounts to save reagent. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Regarding claim 5, Klose teaches an acrylamide:bis-acrylamide weight ratio in the stacking gel of 39:1. (“LDS zymography”, p. 58).
It would be obvious to one of ordinary skill in the art to have, through routine experimentation, utilized various weight ratio of acrylamide:bis-acrylamide so as to optimize the formation of the photopolymerized gel. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Regarding claim 6, Klose teaches the stacking gel has a total acrylamide concentration of 4.0% w/v. (“LDS zymography”, p. 58).
It would be obvious to one of ordinary skill in the art to have, through routine experimentation, utilized various total acrylamide concentration so as to optimize the formation of the photopolymerized gel. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Regarding claim 7, Klose teaches the stacking gel has BisTris amount of 300 mM and a photoinitiator amount of 1% w/v (“LDS zymography”, p. 58).
It would be obvious to one of ordinary skill in the art to have, through routine experimentation, utilized various buffer concentration and photoinitiator amounts so as to optimize the formation of the photopolymerized gel. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Regarding claims 8 and 9, Klose teaches the resolving gel include glycerol (“LDS zymography”, p. 58).
Regarding claim 10, Klose teaches the separation gel has an acrylamide:bis-acrylamide weight ratio of 35.7:1 (“LDS zymography”, p. 58).
It would be obvious to one of ordinary skill in the art to have, through routine experimentation, utilized various weight ratio of acrylamide:bis-acrylamide so as to optimize the formation of the photopolymerized gel. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Regarding claim 20, Klose teaches the separation gel has a polymer composition of 10.7% w/v of acrylamide with 0.3% w/v bisacrylamide, which would inherently result in a density of the polymerized gel (LDS zymography, p. 58). Klose further teaches the stacking gel has polymer composition of 3.9% w/v of acrylamide with 0.1% w/v bisacrylamide, which would inherently result in a density of the polymerized gel (LDS zymography, p. 58). The inherent result of the composition of the two gels yields a separation gel which has a higher density than that of the stacking gel, based on the percent composition of the polymeric monomers.
Claims 11-16, 18, 19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Klose in view of Rong and Wu, and in further view of a US Patent Application Publication to Updyke, et al. (US 2013/0008790 A1; hereinafter, “Updyke”).
Regarding claim 11, the shared limitations with instant claim 1 as taught by the combination of Klose and Rong, in the rejection above.
Klose does not explicitly teach wherein the resolving gel and the stacking gel are polymerizable concurrently in a single step.
However, Wu discloses a one-step casting of a Laemmli SDS-PAGE gel containing a separating gel and a stacking gel (2nd ¶, p. 347).
At the time of the filing of the present application, it would have been obvious to one of ordinary skill in the art to have adapted the methodology of one step casting of stacking and resolving gels as it constitutes a saving of time without loss of separation power (Wu, 2nd ¶, p. 347).
Klose and Rong do not explicitly teach a gel cassette.
However, Updyke disclose acrylamide gel be prepared within a cassette ([0152]). Additionally, Updyke additionally teaches a 365 nm UV lamp to polymerize the electrophoresis gel ([0158]).
At the time of the filing of the present application, it would have been obvious to one of ordinary skill in the art to have utilized the cassette and UV lamp to fabricate the gel taught by the combination of Klose and Rong, as it would allow formation of an array for the separation of polypeptides (Updyke, [0021], Figure 1).
As to the amended limitations, “… [the gels] are polymerized concurrently in a single step via activation of the photoinitiators in both the resolving gel and in the stacking gel to initiate polymerization in both gels at the same time”, this is a product-by-process limitation. "[E]ven 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." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted)
Regarding claim 12, Updyke does not teach a specific light intensity.
However, it would be obvious to one of ordinary skill in the art to have, through routine experimentation, adjusted the light intensity within the claimed range, so as to optimize the formation of the photopolymerized gel. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Regarding claims 13 and 14, Klose teaches the resolving gel include glycerol (“LDS zymography”, p. 58).
Regarding claim 15, Klose teaches the separation gel has an acrylamide:bis-acrylamide weight ratio of 35.7:1 (“LDS zymography”, p. 58).
Regarding claim 21, Klose teaches the separation gel has a polymer composition of 10.7% w/v of acrylamide with 0.3% w/v bisacrylamide, which would inherently result in a density of the polymerized gel (LDS zymography, p. 58). Klose further teaches the stacking gel has polymer composition of 3.9% w/v of acrylamide with 0.1% w/v bisacrylamide, which would inherently result in a density of the polymerized gel (LDS zymography, p. 58). The inherent result of the composition of the two gels yields a separation gel which has a higher density than that of the stacking gel, based on the percent composition of the polymeric monomers.
Allowable Subject Matter
Claims 16-19 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: none of the cited references, considered the closest prior art to the instant claims, anticipates or renders obvious the gels are polymerized concurrently in a single step via activation of the photoinitiators in both the resolving gel and in the stacking gel to initiate polymerization in both gels at the same time. Thus, the method claims 16-19 are allowable over the prior art.
Response to Arguments
Applicant's arguments filed 24 June 2026, have been fully considered but they are not persuasive as to the claims drawn to products (i.e., claims 1-15, 20 and 21). The Applicant has added amended language to instant independent claims 1 and 11 which are product-by-process limitations. Such limitations, where they do not differentiate from the taught product, do not impart patentability to the claim. This is the case in this instance with the limitation, the gels are polymerized concurrently in a single step via activation of the photoinitiators in both the resolving gel and in the stacking gel to initiate polymerization in both gels at the same time.
Additionally, Wu makes comparisons of the resolution of the two step casting and simultaneous casting to show there is not a difference in performance between the two type of gel preparations (1st ¶, right hand column, p. 348). Thus, Applicants arguments against the combining of the teachings of Klose and Wu do not hold weight when viewing the what the references would inform one of ordinary skill in the art, as Wu shows the performance is not risked upon use of a convenience-driven casting technique. The arguments are not persuasive to negate the rejection against claims 1-15, 20 and 21 as outlined above.
Interview with the Examiner
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The Automated Interview Request form (AIR) is available to request an interview to be scheduled with the Examiner. First, an authorization for internet communications regarding the case should be filed prior or with an AIR online request.
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https://www.uspto.gov/sites/default/files/documents/sb0439.pdf
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https://www.uspto.gov/patents/laws/interview-practice#step3
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Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN C BALL whose telephone number is (571)270-5119. The examiner can normally be reached on M - F, 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, Luan Van can be reached on (571)272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J. Christopher Ball/ Primary Examiner, Art Unit 1795
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