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 .
DETAILED ACTION
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 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.
Response to Restriction/Election
Applicant’s election of “peroxydisulfate (PDS)” in response to election of species requirement is acknowledged.
Status of the claims
Claims 1-30 are examined on merits in this office action.
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 1-16 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 1, step a. recites contacting the biological sample with a detectable label and linking the detectable label to one or more targets. The process of linking has not clearly been described in the specification and thus it is unclear as to what type of linking is intended to encompass in the claims as the detectable label may include a dye (fluorescent dye, a fluorescent protein), which does not have any specific recognition moiety for the one or more targets and the biological sample may comprise a liquid sample, as for example, a serum sample.
Claim 4 recites “wherein the step a. comprises contacting the biological sample with a target probe”. The process of step a. recited in claim 4 is unclear because as claimed in claim 4, step a. now comprises steps of contacting the biological sample with a detectable label, linking the detectable label to one or more targets and also contacting the biological sample with a target probe. The relationship of the target probe with respect to detectable label in the process of detection of one or more targets in the biological sample is vague and indefinite. The claim should particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6 recites “wherein step (a) comprises contacting the biological sample with a reporter probe, wherein the dye is linked to the reporter probe. The reporter probe encompasses a dye/fluorescent dye (see paragraphs [0051], [0018]: “reporter probe/fluorophore”, para [0028]: “fluorescent dyes (reporter probes)” and thus it is unclear as to whether the claim is intended for linked dual, as for example, a dye linked to an another of the same or different dye because the specification does not clearly describe a dye or a fluorescent dye (reporter probe) linked to a dye in the process as claimed in claim 1.
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 of this title, 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.
Claims 1-30 are rejected under 35 U.S.C. 103 as obvious over Natarajan et al. (WO2014093455A1) in view of Xu et al (Scientific Reports 2024) and Zhang et al (Journal of Material Res. 2022).
In regards to claims 1, 12, 13 and 16, Natarajan discloses a method for detection of one or more targets in a biological sample (methods for detecting multiple targets in a biological sample; abstract; claim 1), the method comprising: a. contacting the biological sample with a detectable label and linking the detectable label to one or more targets (binding of probes to one or more targets in a biological sample, wherein the probe is a detectable probe that produces a measurable optical signal (note: per instant application a target probe may also comprise themselves of a detectable label; paragraph [0059]); paragraph [0060]; claims 1 and 2); b. detecting a signal from the detectable label (detecting the signal from the probe in the biological sample; claim 1 ); c. after detection at step (b ), contacting the sample of (b) with an electron transfer reagent (e.g. borate salt) (the biological sample is contacted with an electron transfer reagent, wherein the electron transfer reagent causes photoactivated chemical photobleaching; claim 1; abstract; paragraph [0009]); d. irradiating the sample of (c) (irradiating the sample with light; claims 1 and 6), wherein irradiating comprises exposing the sample to light (irradiation of the probe comprises use of light wavelength between 350nm to 1.3 micrometers; claim 6), optionally, wherein the light is a selected wavelength range (optional), wherein the selected wavelength range is within the wavelength range required to detect the detectable label ( optional); e. optionally, repeating steps (a)-(d) (optional).
However, Natarajan does not disclose c. after detection at step (b), contacting the sample having organic dyes with peroxymonosulfate "PMS", peroxydisulfate "PDS", a salt thereof, or any combination thereof, wherein PMS and PDS are represented by the following formulas: formula 1 or formula 2.
Xu teaches PDS and PMS for visible light degradation of organic dyes. Xu teaches PMS for visible light degradation of organic dyes in sample (Abstract). Xu teaches that advanced oxidation processes (AOPs) are considered one of the most promising technologies for complete degradation of various organic dyes by generating highly effective and responsive reactive oxidizing species (ROS) and various oxides such as hydrogen peroxide, sulfate (SO42-), PMS and PDS can be used (page 2, 1st paragraph). Xu discloses combined application of photocatalyst TpTt-COF and PMS for visible light activated degradation of organic dyes in sample (page 2, last paragraph).
Zhang teaches visible light driven polyoxydisulfate (PDS) activated degradation of organic dyes (as for example, Rhodamine B) (Abstract). Zhang discloses highly effective degradation of organic dye in sample with PDS in combination of BiOI/g-C3N4 composite catalyst (page 2092, 1st col. of page 2097; Fig.5). Zhang teaches the following: Generally, PDS could not be directly activated by visible light (λ > 400 nm) irradiation; nevertheless, RhB molecules could be excited by visible light to form the excited state RhB*, which could activate PDS to produce SO4·− via the electron transfer from RhB* to PDS (2nd col., page 2099). Zhang also teaches the followings: The enhancement of degradation efficiency in this system probably resulted from the PDS activation by the photogenerated electrons from the light excited RhB molecules. (2097, 2nd col.).
Therefore, from the description in mind of Natarajan, Xu and Zhang, it would have been obvious to a person of ordinary skill in the art, before effective filing date of claimed invention, to considered PMS or PDS in place of Borate salt in the method of Natarajan with the expectation of expanding the arsenal of photooxidative degradation of the detectable label by irradiating with visible light after step c. with a reasonable expectation of success. One of ordinary skill in the art would be motivated to utilize PMS or PDS because Natarajan is directed to photoactivated chemical photobleaching and both Xu and Zhang teaches alternative compounds PMS or PDS useful for advance oxidative processes (AOPs) having highly efficient photobleaching/degradation of detectable dye and one of ordinary skilled in the art would easily envisage incorporating the alternative PMS or PDS because Xu teaches that advanced oxidation processes (AOPs) are considered one of the most promising technologies for complete degradation of various organic dyes, wherein the process involve at least excitation of dye with visible light, which excitation dye activates PMS or PDS.
In regards to claim 2-5, Natarajan teaches binding at least one probe to one or more targets (claim 1) wherein the target probe comprises a binder and a signal generator wherein the signal generator comprises a cyanine dye ([paragraph 00023]). Natarajan further discloses wherein the light is a selected wavelength within the wavelength range required to detect the detectable label (irradiation of the probe comprises use of light wavelength between 350 nm to 1.3 micrometers, wherein the cyanine Cy3 dye excitation is 520-580 nm and irradiation of Cy3 occurs at the same wavelengths; paragraph [00024]).
In regards to claim 6, teaches wherein step ( c) comprises a reporter probe, wherein the fluorescent detectable label is linked to the reporter probe and wherein the reporter probe is configured to hybridize or bind to the target probe (the detectable probe system may comprise a two probe system, wherein a first probe binds to the target, such as a primary antibody, and a second probe that binds to the first probe, such as a secondary antibody, wherein the second probe comprises a detectable marker; paragraph [000107]). Natarajan further teaches probes may comprise a biotin tag, and the moiety comprising signal generator may also comprise streptavidin capable of binding the biotin tag (para [000121]).
In regards to claim 7, Natarajan teaches suitable binding include antibody and some examples of suitable binder include mouse anti-myc for recombinant expressed proteins with c-myc epitope and antibody for targeting expressed proteins, as for example, thioredoxin fusion proteins and GFP (i.e. a dye) fusion protein (para [000164]). Thus, various biological sample including cells having expressed GFP fusion protein as target would be obvious to one of ordinary skilled in the art.
In regards to claim 8-10, Natarajan teaches various targets including cell surface proteins, DNA and RNA and teaches binders such as DNA, RNA and antibodies (para [00083]).
In regards to claim 11, Natarajan teaches step (d) is carried out in the presence of a buffer at pH of 5-9.
In regards to claim 14, Natarajan does not teach addition of an acid or an anti-oxidant buffer in the process of detecting signal and thus the process is obvious.
In regards to claim 15, Natarajan teaches hematoxylin chromophores for staining (paragraph [000261]). Natarajan also teaches various other dyes (para [00094]). Thus various dyes for contacting with various types of targets would be obvious to one of ordinary skilled in the art.
In regards to claim 17, Natarajan discloses a method for sequential detection of multiple targets in a biological sample (methods for sequentially analyzing a biological sample, wherein multiple targets are analyzed in the sample; paragraph [0009]; abstract), the method comprising: a. contacting a first target probe to the sample, wherein the first target probe is specific for a first target (first set of probes contacted with the sample that is specific for a first set of targets; paragraphs [00040], [000120]); b. hybridizing or binding the first target probe to the first target in the sample (first set of probes contacted with the sample that is specific for a first set of targets, wherein the probes bind to the target; paragraphs [00040], [000120]); c. detecting a first fluorescent detectable label, wherein the first fluorescent detectable label is linked to the first target probe (detecting the detectable signal from the probe (note: per instant application a target probe may also comprise themselves of a detectable label; paragraph [0059]); paragraph [0060]; claims 1 and 2); d. after detection at step (c), contacting the sample of ( c) with an electron transfer reagent ( the biological sample is contacted with an electron transfer reagent, wherein the electron transfer reagent causes photoactivated chemical photobleaching; (claim 1; abstract; paragraphs [0009], [000120]); e. irradiating the sample of (d), wherein irradiating comprises exposing the sample to light (irradiating the sample with light; claim 6; paragraph [000120]), optionally wherein the light is a selected wavelength range of light ( optional), wherein the selected wavelength range is within the wavelength range required to detect the first fluorescent detectable label (optional); f. repeating steps (a)- (e), comprising an Nth target probe and an Nth fluorescent detectable label different from the first probe and first fluorescent detectable label (previous steps can be sequentially completed for any number of repetitions utilizing new probes and targets for each cycle; paragraphs ([00011], [00027], [000119]), optionally, wherein the selected wavelength range of light is within the wavelength range required to detect the Nth fluorescent detectable label (optional).
Natarajan does not disclose c. after detection at step (b ), contacting the sample of (b) with PMS, PDS, a salt thereof, or any combination thereof, wherein PMS and PDS are represented by the following formulas: formula 1 or formula 2.
However, as described above, from the description in mind of Natarajan, Xu and Zhang, it would have been obvious to a person of ordinary skill in the art, before effective filing date of claimed invention, to considered PMS or PDS in place of Borate salt in the method of Natarajan with the expectation of expanding the arsenal of photooxidative degradation of the detectable label by irradiating with visible light after step c. with a reasonable expectation of success. One of ordinary skill in the art would be motivated to utilize PMS or PDS because Natarajan is directed to photoactivated chemical photobleaching and both Xu and Zhang teaches alternative compounds PMS or PDS useful for advance oxidative processes (AOPs) having highly efficient photobleaching/degradation of detectable dye and one of ordinary skilled in the art would easily envisage incorporating the alternative PMS or PDS because Xu teaches that advanced oxidation processes (AOPs) are considered one of the most promising technologies for complete degradation of various organic dyes.
In regards to claims 18, 21 and 22, Natarajan teaches binding at least one probe to one or more targets (claim 1) wherein the target probe comprises a binder and a signal generator wherein the signal generator comprises a cyanine dye ([paragraph 00023]). Natarajan further discloses wherein the fluorescent detectable label is chemically linked to the target probe (the probe and the signal generator that is a detectable probe are coupled together physically or with a linker; paragraphs [000143], [000144]). Natarajan further discloses wherein the light is a selected wavelength within the wavelength range required to detect the detectable label (irradiation of the probe comprises use of light wavelength between 350 nm to 1.3 micrometers, wherein the cyanine Cy3 dye excitation is 520-580 nm and irradiation of Cy3 occurs at the same wavelengths; paragraph [00024]).
In regards to claim 19, Natarajan teaches wherein step ( c) comprises a reporter probe, wherein the fluorescent detectable label is linked to the reporter probe and wherein the reporter probe is configured to hybridize or bind to the target probe (the detectable probe system may comprise a two probe system, wherein a first probe binds to the target, such as a primary antibody, and a second probe that binds to the first probe, such as a secondary antibody, wherein the second probe comprises a detectable marker; paragraph [000107]). Natarajan further teaches probes may comprise a biotin tag, and the moiety comprising signal generator may also comprise streptavidin capable of binding the biotin tag (para [000121]). Thus, various embodiments are obvious to one of ordinary skilled in the art.
In regards to claim 20, Natarajan teaches step (d) is carried out in the presence of a buffer at pH of 5-9.
As per claims 23, 26 and 27, Natarajan discloses a method for detecting a plurality of targets in a biological sample (methods for detecting a plurality of targets using a plurality of probes in a biological sample; paragraph [000121]), the method comprising: a. contacting a plurality of target probes to the sample comprising N subsets of target probes, wherein each probe of the subsets of target probes is specific for different target (applying a plurality of probes in a first set of probes wherein the plurality of probes target a plurality of targets; paragraph [00121]); b. hybridizing or binding the target probes to the plurality of targets in the sample (plurality of probes in a first set of probes bind to a plurality of targets; paragraph [00121]); c. detecting a first fluorescent detectable label, wherein the first fluorescent detectable label is linked to a first subset of the plurality of target probes (detecting a detectable signal on the plurality of probes of a first set of probes, wherein the detectable signal comprises a fluorescent signal (note: per instant application a target probe may also comprise themselves of a detectable label; (paragraph [0059]); paragraph [0060]; claims 1 and 2); d. after detection at step ( c ), contacting the sample of ( c) with an electron transfer reagent (the biological sample is contacted with an electron transfer reagent, wherein the electron transfer reagent causes photoactivated chemical photobleaching; claim 1; abstract; paragraphs [0009], [000121]); e. irradiating the sample of ( d), wherein irradiating comprises exposing the sample to a light (irradiating the sample with light; claim 6; paragraph [000121]), optionally wherein the light is a selected wavelength range of light ( optional), wherein the selected wavelength range is within the wavelength range required to detect the first fluorescent detectable label ( optional); f. repeating steps ( c )-( e) (previous steps can be sequentially completed for any number of repetitions utilizing new probes and targets for each cycle; paragraphs [00011], [00027], [000121]), comprising an Nth fluorescent detectable label linked to an Nth probe, wherein the Nth fluorescent detectable label and the Nth subset of target probes are different from the first subset of target probe and the first fluorescent detectable label (the detectable labels for a first set of probes are used in a first cycle wherein in the following repeated cycles different probes are used with detectable labels, wherein the detectable labels can comprise different detectable labels for each unique set of probes; paragraphs [000121], [000254]), optionally wherein the selected wavelength range of light is within the wavelength range required to detect the Nth fluorescent detectable label ( optional).
Natarajan does not disclose c. after detection at step (b), contacting the sample of (b) with PMS, PDS, a salt thereof, or any combination thereof, wherein PMS and PDS are represented by the following formulas: formula 1 or formula 2.
However, as described above, from the description in mind of Natarajan, Xu and Zhang, it would have been obvious to a person of ordinary skill in the art, before effective filing date of claimed invention, to considered PMS or PDS in place of Borate salt in the method of Natarajan with the expectation of expanding the arsenal of photooxidative degradation of the detectable label by irradiating with visible light after step c. with a reasonable expectation of success. One of ordinary skill in the art would be motivated to utilize PMS or PDS because Natarajan is directed to photoactivated chemical photobleaching and both Xu and Zhang teaches alternative compounds PMS or PDS useful for advance oxidative processes (AOPs) having highly efficient photobleaching/degradation of detectable dye and one of ordinary skilled in the art would easily envisage incorporating the alternative PMS or PDS because Xu teaches that advanced oxidation processes (AOPs) are considered one of the most promising technologies for complete degradation of various organic dyes.
In regards to claim 24, Natarajan teaches wherein the fluorescent detectable labels are chemically linked to the target probes (the probe and the signal generator that is a detectable probe are coupled together physically or with a linker; paragraphs [000143], [000144]).
In regards to claim 25, Natarajan teaches wherein the fluorescent detectable labels are components of detection molecules that are different from the target probes, and are configured to hybridize or bind to the target probes (the detectable probe system may comprise a two probe system, wherein a first probe binds to the target, such as a primary antibody, and a second probe that binds to the first probe, such as a secondary antibody, wherein the second probe comprises a detectable marker; paragraph [000107]).
In regards to claim 28, Natarajan does not teach addition of an acid or an anti-oxidant buffer in the process of detecting signal and thus the process is obvious.
In regards to claims 29 and 30, both Xu and Zhang teach irradiation with visible light and Natarajan teaches irradiation within the range of 350nm to 1.3 micrometers. Natarajan teaches irradiation with visible light of wavelength 300-700nm (para [000211]). Thus, irradiation within the white light range would be obvious to one of ordinary skilled in the art. Natarajan further discloses wherein the light is a selected wavelength within the wavelength range required to detect the detectable label (irradiation of the probe comprises use of light wavelength between 350 nm to 1.3 micrometers, wherein the cyanine Cy3 dye excitation is 520-580 nm and irradiation of Cy3 occurs at the same wavelengths; paragraph [00024]). Thus, for multiplexing with plurality of target probes comprising different fluorophores, utilizing different selected wavelength ranges for irradiation would be obvious to one of ordinary skilled in the art.
Response to argument
Applicant's arguments filed 07/06/2026 have been fully considered but are not persuasive to overcome the rejection under 35 USC 112(b) and 35 USC 103.
In regards to 35 USC 112(b) for “linking the detectable label to one or more targets”, Applicant argued that a skilled artisan would readily appreciate the various strategies for linking a detectable label to a target. For example, protein and nucleic acid targets, respectively, may be linked to the detectable label via a protein binding moiety (e.g., an antibody or antibody fragment) or a nucleic acid binding moiety (e.g., a probe that is complementary to the target).
The above arguments have fully been considered but are not found persuasive because claim 1, step a recites contacting the biological sample with a detectable label and linking the detectable label to one or more target. Specification defines “detectable label” as a molecule that provides the visualization signal and, in some embodiment, detectable labels are dyes or are tissue/cell stains. The “detectable label” in the specification has not been defined as a “dye linked to a binding partner” or a “dye-binding partner conjugate”. Thus the claimed “detectable label” encompasses unconjugated dyes or tissue/cell stains. Thus the process of linking of the unconjugated dye in the process of linking to one or more target molecules are not clear. Moreover, in regards to Applicant’s statement that protein and nucleic acid targets, respectively, may be linked to the detectable label via a protein binding moiety, it is noted that the features upon which applicant relies (i.e., detectable labels linked to a protein binding moiety) are not recited in the rejected in claim 1. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In regards to 35 USC 112(b) rejection for claim 4, the arguments have been rendered moot in view of the new grounds of rejection as described in this office action that are necessitated by Applicant’s amendments.
In regards to 35 USC 112(b) rejection of claim 6 for “reporter probe, wherein the dye is linked to the reporter probe”, Applicant asserts that reporter probe refers to a molecule (e.g., "an antibody, a nanobody, a nucleic acid, etc.") comprising the detectable label. Applicant cited paragraphs [0061]-[0062] of the specification for the assertion.
The above arguments have fully been considered but are not found persuasive because paragraph [0061] of the specification states “As used herein, a “reporter probe” comprises a molecule including an optical signal generator (a detectable label)”. Thus, paragraph [0061] defined the “reporter probe” as a detectable label”. Paragraph [0061] also recites the followings: “By way of example but not by way of limitation, a reporter probe may comprise an antibody, nanobody, a nucleic acid, etc. chemically linked to a detectable label”. Note that example is not a clear definition for a term and the recitation starting with “may” can not be considered as a clear definition for a term when the definition of “reporter probe” directed to a “detectable label”, not an antibody. Moreover, the claims (see amendment claim 5 and amended claim 6) does not clearly distinguish target probe from the reporter probe but, throughout the specification, teaches reporter probe as a dye/fluorescent dye (see paragraphs [0051], para [0018]: “reporter probe/fluorophore”, para [0028]: “fluorescent dyes (reporter probes)”.
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(para [0051]).
Therefore, throughout the specification, “reporter probe” are described as “detectable label’, not an antibody. Furthermore, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In regards to the 35 USC 103 rejection of Natarajan in view of Xu and Zhang, Applicant argued that the method disclosed in Xu and Zhang both involve the activation of PMS or PDS by photocatalyst and subsequent degradation of an organic dye by the activated PMS/PDS and in contrast, the claimed methods involve a detectable label that that both activates the PMS/PDS and is photobleached by the activated PMS/PDS.
The above arguments have fully been considered but are not found persuasive because both the reference of Xu teaches visible light irradiation of dye with PMS in the presence of photocatalyst TpTt-COF (See page 3 of Xu) and the reference of Zhang teaches visible light irradiation of dye in the presence of BCN/PDS (see Zhang: Title and page 2097). Therefore, irradiation of visible light in Xu and Zhang would excite the dye and would be expected to actives PMS and PDS. Contrary to Applicant’s arguments that but Xu and Zhang involve activation of PMS or PDS , Zhang teaches the following:
Generally, PDS could not be directly activated by visible light (λ > 400 nm) irradiation; nevertheless, RhB molecules could be excited by visible light to form the excited state RhB*, which could activate PDS to produce SO4·− via the electron transfer from RhB* to PDS (2nd col., page 2099).
Zhang also teaches the followings:
The enhancement of degradation efficiency in this system probably resulted from the PDS activation by the photogenerated electrons from the light excited RhB molecules. (2097, 2nd col.).
Therefore, contrary to Applicant’s assertion, degradation of organic dye in the method of Xu and Zhang by irradiation of visible light would obviously involve excitation of dye, activation of PMS or PDS by the activated dye and photobleaching by PDS or PMS.
Furthermore, as evidenced from the attached reference (Yang et al. Water Res. 2021), visible light irradiation excites electrons in the dye molecules from the highest occupied molecular orbital (HOMO) to the lowest unoccupied molecular orbital (LUMO), and those excited electrons are accepted by PS (persulfate) to generate active radicals (Fig. 3A) and the dye molecule act as both a photosensitizer and a substrate to be degraded (page 5, 1st col., section 3.1).
Moreover, the recitation : “the method comprising:” in line 2, allows additional step(s) of adding other compounds (as for example, photocatalyst compounds) in the additional steps.
Conclusion
Applicants’ amendment necessitated new ground(s) of rejection presented in this office action. Accordingly, 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 extension fee 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 date of this final action.
If Applicants should amend the claims, a complete and responsive reply will clearly identify where support can be found in the disclosure for each amendment. Applicant should point to the page and line numbers of the application corresponding to each amendment, and provide any statements that might help to identify support for the claimed invention (e.g., if the amendment is not supported in ipsis verbis, clarification on the record may be helpful). Should Applicants present new claims, Applicants should clearly identify where support can be found in the disclosure.
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/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
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