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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/1/26 has been entered.
Status of Claims
Applicant’s reply filed on 4/1/26 is acknowledged. Claims 1-33, 35, 41 and 49 were canceled. Claims 34, 36-40, 42-48 and 50-53 are pending and are under examination.
Response to Reply
Claim Rejections - 35 USC § 101
In light of applicant’s claim amendment and arguments, the prior rejection under 35 U.S.C. 101 is modified and maintained. The Office acknowledges applicant’s arguments, however, the rejection is maintained because “comparing the calibration reading to the known mass” is considered an evaluation; and “to determine one or more functional properties of the cells to determine one or more of mass, growth rate, or MAR of the cells is also considered an evaluation, and there are abstract ideas. While applicant argues “determining MAR requires calibrating an SMR instrument . . . that cannot be performed mentally, the Office does not find applicant’s argument to be persuasive because “claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer” cannot be distinguished. See MPEP 2106.04(a)(2)(III). Thus, the claimed steps, while performed with a SMR instrument, can be performed by a human, mentally or with a pen and paper.
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 34, 36-40, 42-48 and 50-53 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 34, for example, recites “comparing the calibration reading to the known mass,” and “to determine one or more functional properties of the cells to determine one or more of mass, growth rate, or MAR of the cells is also considered an evaluation”. Because these recitations are considered evaluations, they are abstract ideas. See MPEP 2106.04(a)(2)(III). This judicial exception is not integrated into a practical application because after the functional properties are determined then no action is taken. The calibration and measuring appears to be insignificant extra solution activity and not a particular practical application (MPEP 2106.05(g)). The SMR does not appear to provide significantly more because the SMR is a machine on which the method operates. MPEP 2106.05(b)(II). Claim 34 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because claim 34 recites a measurement instrument, SMR, which is well-understood, routine, conventional activity.
Dependent claims all further refine the method steps and were considered, however, the subject matter does not affect the result established above.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 43-45 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The subject matter claimed in claims 43-45 does not show support for a “synthetic” reference material. The originally filed disclosure does not show support for a synthetic reference material referring to a cell. The originally filed disclosure does not show support for a synthetic reference material referring to a e.g., lipid mass.
In light of applicant’s claim amendments, the prior rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn, and a new rejection follows.
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.
Claim 52 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 52 is rejected for indefiniteness because each claim merely recites a use, e.g., “used to,” without any active, positive steps delimiting how this use is actually practiced. See MPEP 2173.05(q).
Claim Interpretation under 35 U.S.C. 112(f)
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 use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) are not 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”. Such claim limitation(s) is/are: chemical, biochemical, or mechanical means in claim 44.
Because 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, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Interpretation of the pending claims
While all words in each claim are considered in judging the patentability of the claim language, including functional claim limitations, not all limitations provide a patentable distinction.
During patent examination, the examined claims must be given their broadest reasonable interpretation consistent with the specification, unless a term has been given a special definition in the specification (“BRI”). See MPEP 2111.
Prior Art Rejections
In light of applicant’s claim amendments, the prior art rejections are modified below.
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.
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.
Claims 34, 36, 42-48 and 50-53 are rejected under 35 U.S.C. 103 as being unpatentable over Babcock et al. (“Babcock,” US Pub. No. 2009/0044608, previously cited) in view of Manalis et al. (“Manalis,” WO 2018/236708 A1, previously cited).
As to claim 34, Babcock teaches a method comprising:
introducing a deformable or elastic reference material (e.g., [0016-0017], [0041-0042] discloses “cells organelles, bacteria, spores, platelets and other blood components, droplets in emulsions, and any other matter of particulate form suspended in a fluid,” which are deformable or elastic material) having a known mass (e.g., [0042-0049] et seq.) into a sensor on a suspended microchannel resonator (SMR) instrument (e.g., [0025] et seq.) to generate a calibration reading (e.g., [0011-0054] et seq.);
comparing the calibration reading to the known mass (e.g., [0029] et seq.);
adjusting an output module of the SMR instrument until the calibration reading corresponds to the known mass, thereby calibrating the SMR instrument (e.g., [0053-0054] et seq.).
Regarding claims 34 and 43, while Babcock teaches flowing a sample comprising cells through the SMR instrument (e.g., [0042] et seq.); and measuring the mass of the cells as the cells flow through the SMR instrument to determine one or more functional properties of the cells to determine one or more of mass, growth rate, or mass accumulation (MAR) of the cells (e.g., Details of the bacteria mass distribution such as width and asymmetry provide insight into bacterial growth and division processes in [0042] of Babcock; also see e.g., p. 41, lines 3-4 of Manalis), Babcock does not specifically teach introducing a synthetic reference material and the sample comprising cells is from a subject. With regard to introducing a synthetic reference material, Manalis teaches on p. 4 et seq., experiments with synthetic hydrogens in fig. 13G. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to introduce a synthetic deformable or elastic reference material, such as a synthetic hydrogel, because synthetic hydrogels are known in the art to have many beneficial properties, such as being robust, and can be applied to a variety of applications. With regard to the sample comprising cells from a subject, Manalis teaches on p. 9 et seq., the biological entity (“cells”) is obtained from a subject. A "subject" refers to any animal such as a mammal (e.g., a human). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to obtain the sample from a subject because it would provide the ability to study particular diseases in detail.
As to claim 36, [0011] et seq. of Babcock teaches measuring target particles, such as cells, in a suspended microchannel resonator.
As to claims 42, 47 and 48, Babcock does not specifically teach the material comprises hydrogel with deformability or elasticity. Manalis teaches on p. 43, lines 7-14, analyzing uniform hydrogels with different aspect ratios revealed that node deviation is not sensitive to particle shape for particles with aspect ratios up to 1-2.5 (see FIG. 13G, which shows node deviation versus aspect ratio from experiments with synthetic hydrogels of different shapes but the same volume (n=384, 423 and 474 for
aspect ratio 1, 1.5 and 2.5, respectively)). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to analyze hydrogels because it would be beneficial to recognize that analyzing uniform hydrogels with different aspect ratios revealed that node deviation is not sensitive to particle shape for particles with aspect ratios up to 1-2.5 (e.g., p. 43, lines 7-14 of Manalis).
As to claim 44, Babcock does not specifically teach an altered cell through chemical, biochemical or mechanical means. Manalis teaches on p. 37, line 6 et seq., FIG. 8B shows the normalized node deviation of mechanically altered cells. L1210 cells were treated with Latruculin B (LatB) for actin depolymerization or fixed with Paraformalhyde (PFA) for cell surface cross-linking. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to have a material comprise an altered cell through chemical, biochemical or mechanical means because it would provide the ability to study a broad range of cells.
As to claim 45, see e.g., [0041] et seq. of Babcock.
As to claim 46, see e.g., [0042] et seq. of Babcock.
As to claim 50-51, see e.g., abstract and [0053] et seq. of Babcock.
As to claim 52, see e.g., [0054] et seq. of Babcock.
As to claim 53, see e.g., [0053] et seq. of Babcock.
Claims 37-40 are rejected under 35 U.S.C. 103 as being unpatentable over Babcock in view of Manalis, as applied to claim 34 above, and further in view of Bashir et al. (“Bashir,” US Pub. No. 2014/0026686, previously cited).
See Babcock and Manalis above.
As to claim 37, while Babcock teaches measuring the change in mass of the cells flowing through the instrument in [0011] and [0042], Babcock does not specifically teach measuring a mass accumulation rate (MAR). Bashir teaches in FIG. 12C shows that the distribution of mass changes depicts an increased rate of mass accumulation for heavier cells and that the cell growth rate is linearly increasing with the cell mass. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to measure a mass accumulation rate of the cells to understand the growth characteristics of the cells ([0126] of Bashir).
As to claims 38 and 40, while Babcock teaches the sample can be cells, Babcock does not specifically teach cancer cells. Manalis teaches on p. 9, the particle is a biological entity. Non-limiting examples of biological entities include virions, bacteria, protein complexes, exosomes, cells (e.g. cancer cells). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to specifically measure cancer cells because it would provide the ability to study particular diseases in detail.
As to claim 39, see e.g., [0129] of Bashir. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to characterize heterogeneity in cell growth of the cancer to gain greater perspectives into how cells grow individually and as a population ([0130] of Bashir).
Double Patenting
In light of applicant’s claim amendments, the prior rejection on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,346,755 is modified. See below.
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 34, 36-40, 42-48 and 50-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 11,346,755. Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims and the patented claims comprise substantially the same subject matter. For example, the examined claim 34, and the patented claim 1 comprise a method of calibration comprising: introducing a material with cell-like properties and a known mass into a sensor on a measurement instrument to generate a calibration reading; and adjusting an output module of the measurement instrument until the measurement instrument calibrates to the known mass for the material.
Response to Arguments
Applicant's arguments filed 4/1/26 have been fully considered but they are not persuasive in light of the amended rejection above.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORE RAMILLANO JARRETT whose telephone number is (571)272-7420. The examiner can normally be reached Monday to Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at 571-272-1254.
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/LORE R JARRETT/Primary Examiner, Art Unit 1797
8/1/26
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