DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claim 24 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 2/19/2026.
Applicant argues that the “structured capture array” of Claim 24 is a not a standalone invention and the claim is inextricably linked to Claim 13. Applicant identifies the alleged “inventive concept” as “revolv[ing] around using surface tension and meniscus formation”.
For unity of invention to exist, the common technical feature among claims must be a special technical feature which is one that makes a contribution over the prior art. As an initial matter, Claim 13 in its entirety is not novel. Please see the rejection below.
Further, the process limitations of Claim 13 which Applicant identifies as being the relevant common features between the claims, do not limit the structure of the claimed “structured capture array” as the claim 24 is drawn to an apparatus and process limitations are not further limiting to an apparatus. The recited “configured to” limitations do not require a process to occur. Rather, the device just must be capable of performing the claimed function. As such, Claim 24 does not actually require the process limitations of Claim 13 as Applicant alleges.
Regardless, all of the common structure is anticipated by Cerf et al. as is shown below and the entirety of Claim 13 is obvious over Cerf et al. which is explained below.
Claim Interpretation
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim 13 recites “a covering means such that…” which invokes 112(f). The structure is interpreted with respect to the disclosure. In [0090], the “covering means” is a glass or oxidized silicon item.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 13:
“the deposited complex fluid” lacks antecedent basis in the claim.
It is unclear what a “covering means” is and the structure required. As per the 112(f) interpretation above, the disclosure was consulted but there is no clear structure that can be clearly identified. As such, it is impossible to discern what structure is required.
It is unclear what a “rear meniscus” and a “front meniscus” is as these are relative terms wherein the claim does not provide any way for one to discern how “rear” and “front” are determined, and with respect to what.
“the surface tension” lacks antecedent basis in the claim.
“the air maximal humidity” lacks antecedent basis in the claim
Claim 14:
“the maximal moisture content of the surrounding air” lacks antecedent basis in the claim.
Claim 15:
“in particular the biological molecules…” and “particularly” are indefinite as it is unclear if these limitations are required or preferred embodiments. For the purpose of prior art search and claim interpretation is it is interpreted that these are preferred embodiments.
Claim 16:
“in particular the biological molecular…” is indefinite as it is unclear if these limitations are required or preferred embodiments. For the purpose of prior art search and claim interpretation is it is interpreted that these are preferred embodiments.
Claim 17:
It is unclear what “an individual” requires and if there is any specific step required here.
“in particular said biological fluid…” and “especially” are indefinite as it is unclear if these limitations are required or preferred embodiments. For the purpose of prior art search and claim interpretation is it is interpreted that these are preferred embodiments.
Claim 18
“particular” is indefinite as it is unclear if these limitations are required or preferred embodiments. For the purpose of prior art search and claim interpretation is it is interpreted that these are preferred embodiments.
Claim 19
“particularly” is indefinite as it is unclear if these limitations are required or preferred embodiments. For the purpose of prior art search and claim interpretation is it is interpreted that these are preferred embodiments.
Claim 20
“wherein molecules and/or…have to be isolated” is indefinite as it is unclear if this is a process step or an intended outcome of the step; it is unclear what is required of this limitation.
The “wherein step c)” is indefinite as it is unclear if the step c is performed twice at each of two different speeds for each radius or if it is that the step c is carried out one time at one speed and then a second time at a second speed. Clarification is required.
Claim 21
“wherein molecules and/or…have to be isolated” is indefinite as it is unclear if this is a process step or an intended outcome of the step; it is unclear what is required of this limitation.
“a second portions” is indefinite as it is unclear if there are multi second portions or just one.
“the spatial separation” lacks antecedent basis in the claim.
Claim 23
“the surface of the structured capture array” lacks antecedent basis in the claim.
“the trapped molecules…” lacks antecedent basis in the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 13-23 rejected under 35 U.S.C. 103 as being unpatentable over Cerf et al. (2009) in view of Soueid et al. (2015).
Claims 13, 15, 16, 17: A method for in vitro isolating molecules and/or molecular complexes having a radius of gyration smaller or equal to 2 um from a complex fluid (page 1420, 2.1, phage lambda DNA solution, i.e. a non-Newtonian fluid), said method comprising the following steps: a) contacting a complex fluid with a structured capture array having topographical features in the form of a plurality of plane surfaces in-between cavities (Scheme 1, 2). There is no specific disclosure of the air conditions. However, it is presumed that the experiment is run under generic air humidity conditions wherein the preferred standard air condition for nanoscale research is 40-45% RH (Soueid et al., 2015, see pdf in file, abstract). As such, one of ordinary skill in the art would have expected the relative humidity of the conditions to be 40-45%. b) covering the deposited complex fluid with a covering means (Cerf et al., 2.3., “glass slide”) such that the complex fluid is surrounded by a meniscus which comprises a rear meniscus and a front meniscus, wherein the surface tension of the complex fluid between the covering means and the structured capture array defines at least the front and the rear meniscus (Cerf et al., 2.3.); and c) dragging either the covering means or the structured capture array in one direction at a speed of at most 2 mm.s-1 for displacing the complex fluid (Cerf et al., 2.3.), wherein the front and the rear menisci are displaced on and along the topographical features of said structured capture array toward said direction, wherein the front meniscus covers uncovered topographical features and the rear meniscus uncovers covered topographical features during displacement of the complex fluid (Cerf et al., 2.3.), resulting in the molecules and/or the molecular complexes are trapped inside the cavities (Scheme 1, 1).
Claim 18: the complex fluid is blended with triton X100 (Materials 2.1; 3.2 Influence of Surfactant).
Claim 19: Cerf et al. teach the concentration of triton X100 in wt.% which is not the same or directly convertible to v/v%. However, they also teach that the concentration of the surfactant is a well-known routinely optimized result effective variable that affects the receding angle and meniscus between the DNA and the PDMS surface (3.2). “[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.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Claim 20: Cerf et al. do not specifically teach carrying out step c) twice at different speeds.
However, they teach that tailoring the speed of the translation can create “single DNA molecules arrays or more complex networks” (3.1). They also teach that the “experimental parameters)” including “speed” are “adjusted” to comb single DNA molecules with high placement accuracy (2.3. Experimental setup).
Given that the speed is clearly recognized as a result effective variable, one of ordinary skill in the art would have – through routine experimentation – readily determined the optimal combination of speeds that resulted in proper separation. The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Claim 21: Cerf et al. do not explicitly teach two different size cavities.
However, they teach “The size and geometry of the patterns were chosen to allow the trapping of a single coiled DNA molecule” (2.2. Fabrication of master and stamps). As such, the size is clearly a routinely optimized result effective variable wherein the size is chosen to separate DNA molecules of specific sizes. Providing an additional area of cavities having different sizes would have been obvious for the benefit of separation DNA molecules of different sizes. “[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.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Claim 22: Cerf et al. teach that it is known in the art to tether DNA to positively charged patterns (i.e. functionalized surface)(1. Introduction). Functionalizing the surface allows for better bonding of the DNA to the surface for better separation. For this reason, one of ordinary skill in the art at the time of the invention would have found it obvious to functionalize Cerf et al.’s topological features.
Claim 23: the surface is contacted with a printing surface (Scheme 1, 3).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLISON FITZSIMMONS whose telephone number is (571)270-1767. The examiner can normally be reached M-F 9:30 am - 2:00 pm.
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ALLISON FITZSIMMONS
Primary Examiner
Art Unit 1773
/ALLISON G FITZSIMMONS/Primary Examiner, Art Unit 1773
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