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 .
Claims 202-216 are pending. Claims 1-201 are cancelled.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted 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 device is configured to flow a plurality of flow streams from the plurality of inlets to the plurality of outlets” in claim 202.
“the channel configured to deflect particles in a sample comprising the particles toward the second wall when the particles are flowed from the inlets to the outlets” in claim 202.
“the at least one separator wall is configured to delay the flow of deflected particles” in claim 202.
“the first and second separator walls are configured to limit mixing between adjacent parallel flow streams” in claim 212.
“the gap is configured to allow particles deflected through the adjacent parallel flow streams toward the second wall to pass between the pair of opposing separator walls” in claim 212.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not 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: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 202-216 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 202 is vague. In line 7, the recitation of “theparticles” should be –the particles--.
Claim limitation:
• “the device is configured to flow a plurality of flow streams from the plurality of inlets to the plurality of outlets” in claim 202
• “the channel configured to deflect particles in a sample comprising the particles toward the second wall when the particles are flowed from the inlets to the outlets” in claim 202
• “the at least one separator wall is configured to delay the flow of deflected particles” in claim 202
• “the first and second separator walls are configured to limit mixing between adjacent parallel flow streams” in claim 212
• “the gap is configured to allow particles deflected through the adjacent parallel flow streams toward the second wall to pass between the pair of opposing separator walls” in claim 212
invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The claims do not recite the specific structures for performing the claimed function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Double Patenting
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.
Claims 202-210 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 11-13 of U.S. Patent No. 11,493,428. Although the claims at issue are not identical, they are not patentably distinct from each other because patent ‘428 claims a device that is similar to the instant invention.
Patent ‘428 claims:
1. A microfluidic device comprising:
(a) a channel extending from a plurality of inlets to a plurality of outlets, wherein the channel is bounded by a first boundary wall and a second boundary wall opposite from the first boundary wall; and
(b) an array of obstacles arranged in rows and columns disposed within the channel wherein subsequent rows of the obstacles are offset from each other by a tilt angle greater than zero, and wherein particles above a critical size are deflected by the obstacles toward the second boundary wall when the particles are flowed from the inlets to the outlets;
wherein the device is configured such that the particles are inputted into at least one of the plurality of inlets and are deflected through a series of parallel flow streams flowing from the plurality of inlets to the plurality of outlets while being deflected toward the second boundary wall, and
wherein the series of parallel flow streams comprises a first reagent flow stream comprising a first binding agent, a second reagent flow stream comprising a fixation agent, a third reagent flow stream comprising a permeabilization reagent, and a fourth reagent flow stream comprising a second binding agent, wherein the first binding agent comprises a first detectable label, and wherein the second binding agent comprises a second detectable label.
2. The device of claim 1, wherein the particles are cancer cells, or leukemia cells.
3. The device of claim 1, wherein the particles are leukocytes, a subtype of leukocytes or stem cells.
11. The device of claim 1, wherein the obstacles are arranged in rows and columns, wherein the rows define an array direction that differs from the flow of the plurality of parallel flow streams by a tilt angle (ϵ) that has a magnitude greater than zero and less than or equal to ⅓ radian, the obstacles in each respective column defining gaps between the obstacles through which the fluid flows generally transversely with respect to the columns, and wherein the obstacles are shaped such that surfaces of two obstacles defining a respective gap are asymmetrically oriented about a first plane that extends through the center of the respective gap and that is parallel to the flow of the plurality of parallel flow streams.
12. The device of claim 11, wherein the array of obstacles comprises at least one separator wall oriented parallel to flow of the plurality of flow streams and the first and second boundary walls, wherein the particles introduced into an sample inlet near the first wall pass through the plurality of flow streams while being deflected toward the second wall.
13. The device of claim 12, wherein the at least one separator wall is positioned between the first and second boundary walls to delay the flow of deflected particles toward the second wall, wherein the delay serves to substantially increase an amount of time that deflected particles reside in a flow stream, and/or substantially reduce mixing between parallel flow streams.
Patent ‘428 differs from the instant invention in failing to how far along the length of the channel the separator wall extends into the interior of the array of obstacles recited in claim 202, the specific increased amount of time the particles reside in the flow stream caused by the separator wall recited in claims 203-205 or the specific separator wall lengths recited in claims 209-210.
With respect to claims 202, it has been long settled to be no more than
routine experimentation for one of ordinary skill in the art to discover an optimum value
for a result effective variable. Where the general conditions of a claim are disclosed in
the prior art, it is not inventive to discover the optimum of workable ranges by routine
experimentation. Application of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236
(C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process
by routine experimentation. Id. At 458, 105 USPQ at 236-237. The “discovery of an
optimum value of a result effective variable in a known process is ordinarily within the
skill of the art”. Absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of how far along the length of the channel the separator wall extends into the interior of the array of obstacles for particle separation by normal optimization procedures known in the particle separation art.
With respect to claims 203-205, it has been long settled to be no more than
routine experimentation for one of ordinary skill in the art to discover an optimum value
for a result effective variable. Where the general conditions of a claim are disclosed in
the prior art, it is not inventive to discover the optimum of workable ranges by routine
experimentation. Application of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236
(C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process
by routine experimentation. Id. At 458, 105 USPQ at 236-237. The “discovery of an
optimum value of a result effective variable in a known process is ordinarily within the
skill of the art”. Absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the separator wall to increase the amount of time particles reside in the flow stream by normal optimization procedures known in the particle separation art.
With respect to claims 209-210, it has been long settled to be no more than
routine experimentation for one of ordinary skill in the art to discover an optimum value
for a result effective variable. Where the general conditions of a claim are disclosed in
the prior art, it is not inventive to discover the optimum of workable ranges by routine
experimentation. Application of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236
(C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process
by routine experimentation. Id. At 458, 105 USPQ at 236-237. The “discovery of an
optimum value of a result effective variable in a known process is ordinarily within the
skill of the art”. Absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the separator wall length to increase the amount of time particles reside in the flow stream by normal optimization procedures known in the particle separation art.
Allowable Subject Matter
Claims 202-216 are free of the prior art. Huang (US PGPub 2007/0026381) is the closest prior art and discloses a deterministic lateral displacement microfluidic device comprising a plurality of fluidically connected inlets and outlets, said device comprises an array of obstacles that directs particles in a fluid to predetermined boundaries. However, Haung does not disclose a separator wall in a channel that delays the flow of deflected particles.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L CHIN whose telephone number is (571)272-0815. The examiner can normally be reached Monday - Friday, 10:00am - 6:30pm.
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/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
6/25/2026
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