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 .
Status of Claims
Claims 27, 31-33, 38, 43, 52, 106, 113-117, 119, 124, 137, 169, 177, 178 and 193 were pending. Claims 113-117, 119, 124, 137, 169, 177 and 178 are withdrawn.
Claims 27, 31, 33, 38, 43, 52, 106, and 193 have been amended, and claim 32 has been cancelled.
Claims 27, 31, 33, 38, 43, 52, 106, and 193 examined herein.
Withdrawn Rejections
The objection to disclosure is withdrawn in view of disclosure amendments.
The objection to claim 106 is withdrawn in view of claim amendments.
The rejection of claims 38 and 43 on the basis of improper Markush groupings of alternatives is withdrawn in view of claim 38 amendments.
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.
Claim 33 is 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.
Claim 33 recites the capture molecule is bound to a magnetic bead or a metallic bead. In the non-final Office Action (mailed 9 April, 2025) claim 33 was rejected under 112(a) because it recited limitation of “affixing the capture molecule to the scaffold upon the cycling of an electric current or a magnetic field, wherein the capture molecule is bound to a magnetic or metallic bead” (pg. 5). The limitation of cycling of an electric current or a magnetic field claim was removed from the claim, but the magnetic/metallic beads depend entirely on the removed limitation according to the specification. Therefore, the previous rejection stays:
Claim 33 recites affixing the capture molecule to the scaffold upon the cycling of an electric current or a magnetic field, wherein the capture molecule is bound to a magnetic or metallic bead. The prior art is silent on affixing said capture molecule to the scaffold upon the cycling of an electric current or a magnetic field. The specification fails to disclose how the recited limitation of the cycling is expected to work. Applicant fails to provide working examples demonstrating how the cycling works and what results are achieved.
Magnetic particles can be concentrated on a detector surface/scaffold using a magnetic field of appropriate orientation. Similarly, charged particles can be concentrated on a detector surface/scaffold using an electric field of appropriate orientation. However, in these scenarios the fields cannot be changing in a periodic fashion. The particles would concentrate on the detector surface/scaffold during one half of the cycle and desorb during another half of it. In the absence of appropriate means for holding the particles on the surface/scaffold the final result for either magnetic or electric field would be a net zero movement. Applicant fails to disclose appropriate means for holding the particles on the surface/scaffold.
Additionally, metal particles are not necessarily charged without specific surface treatment, and the specification fails to disclose such a treatment.
Based on the above findings, one of ordinary skill in the art would conclude that Applicant did not have possession of the claimed invention at the time the application was originally filed.
Additionally, prior art is silent on a method that could be used to bring a generic metallic bead into a contact with the detector, if the bead is not magnetic. Therefore, a metallic bead of claim 33 is not supported by prior art or the specification.
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 27, 31, 33, 52, 106 and 193 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 27 recites “which antibody or aptamer immobilizes the marker at the detector, where the antibody or aptamer binds the capture molecule to the substrate”. Line 4 recites that the capture molecule is already bound or capable of binding to the substrate without assistance of any antibody or aptamer. It is the antibody or aptamer that are immobilized via the capture molecule. It is unclear how the antibody or aptamer can bind the capture molecule to the substrate (see, Fig. 1). Claim 52 recites similar unclear limitations while reciting the first capture molecule and the first substrate, and the second capture molecule and the second substrate. Claim 193 recites similar unclear limitations: “where the antibody or aptamer binds a capture molecule to a substrate”.
Claim 27 recites “where amphiphilic lipid vesicle binds the immobilized marker with a detection molecule”. The function of the detection molecule is unclear, because the claimed method detects the detectable label and according to the specification the detection molecule is different from the detectable label. The detection molecule is a component having no role in the claimed assay. Claims 52 and 193 recite similar unclear limitation of the detection molecule.
Claim 27 recites “wherein the capture molecule is affixed to the substrate or is capable of being affixed to the substrate comprises affixing to the substrate at the detector for the detectable label.” The limitation of “affixing to the substrate at the detector for the detectable label” is confusing and indefinite. Claim 52 recites similar indefinite limitations in the last two wherein clauses.
Claim 27 recites “contacting the marker-bound antibody with conditions capable of releasing the detectable label from the amphiphilic lipid vesicle on the antibody”. It is unclear why the claim recites contacting the marker-bound antibody with conditions capable of releasing the detectable label, but not the amphiphilic lipid vesicle itself. The detectable label is not contained in the marker-bound antibody. It is the amphiphilic lipid vesicle immobilized via the capture molecule that should be contacted with conditions capable of releasing the detectable label. Claims 52 and 106 recite similar unclear limitations.
Claims 27, 52 and 193 recite “at the detector”. The term “at” is a relative term which renders the claim indefinite. “At” can be used to indicate presence or occurrence in, on, or near. For example, in, on, or near the detector area, but without clear indication of the distance from the detector. The term “at” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 33 recites “the capture molecule is bound to a magnetic bead or a metallic bead”. It is unclear from the context of parent claim 27 what is the function of the beads and how the amphiphilic lipid vesicle comprising the detectable label is related to the beads.
Additionally, the specification discloses the beads only in the context of “capture molecule may be bound to a magnetic bead or a metallic bead, wherein the capture molecule binds to the scaffold upon the cycling of an electric current” ([0017]). In the non-final Office Action (mailed 9 April, 2025) claim 33 was rejected under 112(a) because of recited limitation of “affixing the capture molecule to the scaffold upon the cycling of an electric current or a magnetic field, wherein the capture molecule is bound to a magnetic or metallic bead” (pg. 5).
The limitation of cycling of an electric current or a magnetic field claim was removed from the claim, but the magnetic/metallic beads depend entirely on this limitation according to the specification.
The magnetic or metallic beads of claim 33 have no relevance to the method for detecting a marker of claim 27. Due to the difficulty of interpreting this limitation claim 33 is not given any patentable weight. Please, see 112(a) rejection above for details.
Claims 38 and 43 recite a detectable label comprising a magnetic particle, a metal particle, a particle of 1 pg or greater, a spore, a charged particle, or an ionic solution. The claims are indefinite because they use the open “comprising” language.
Claim 52 recites twice “lipid vesicle including a detectable label” and twice “lipid vesicle binds the immobilized marker with a detection molecule”, then it recites “releasing a first detectable label” and “releasing a second detectable label”. It is unclear where the first and second detectable labels come from, how they relate to previously recited “a detectable label”, and if the detectable labels and the detection molecules refer to the same or different entities.
Additionally, the claim recites “the detector” (paragraph starting with “contacting the first marker”). There is insufficient antecedent basis for “the detector” in the claim.
Moreover, the claim recites “the detector” (paragraph starting with “contacting the second marker”). It is unclear if this detector is the same or different as “the detector” recited in paragraph starting with “contacting the first marker”.
Finally, it is unclear if the first and second substrates are fluidically separated, and if “conditions capable of releasing a first detectable label” are the same or different from “conditions capable of releasing a second detectable label”.
Claim 106 recites “An antibody or aptamer for the detection of a marker by a detector generating a detection signal comprising: an amphiphilic lipid vesicle”. It is unclear how an antibody or aptamer can comprise an amphiphilic lipid vesicle, because the claim no longer recites antibody or aptamer conjugates.
Claim 193 recites “where the capture molecule bound to the substrate comprises the capture molecule bound to the substrate at the detector for a detectable label.” It is unclear the recited capture molecule relates to the claimed antibody or aptamer. The limitation with the capture molecule belongs to a method of detection, not the antibody or aptamer.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 27, 31, 38, 43, 52 and 193 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Johari-Ahar et al. (IDS; Biosens Bioelectron. 2018 Jun 1; 107:26-33).
Regarding claims 27, 38, 43, 52 and 193, Johari-Ahar teaches a method for detecting a marker in a sample by a detector generating a detection signal, the method comprising:
contacting the sample with a capture molecule that binds the marker, wherein the capture molecule is affixed to a substrate - specifically, the reference teaches using a gold electrode (Au-SPE)-based biosensor coated with a molecularly imprinted polymer (the capture molecule) affixed to the electrode (the substrate and the detector). The molecularly imprinted polymer is synthesized to have specificity toward two cancer biomarkers: epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF) (Abstract and Scheme 1 - step with analytical sample added to the imprinted polymer). After this step the marker becomes embedded into the molecularly imprinted polymer;
contacting the marker with a composition comprising an antibody linked to an amphiphilic lipid vesicle including a detectable label - specifically, Johari-Ahar teaches adding antibody tagged liposome solution to the marker embedded into the molecularly imprinted polymer (Scheme 1); and
the detectable label - Cd (II) and Cu (II) ions loaded into the liposome (pg. 28, col. 1, section 2.2.3),
wherein the antibody binds to a different epitope on the marker than the capture molecule - the molecularly imprinted polymer and the antibody of Johari-Ahar bind to the markers at the same time forming a sandwich structure, therefore the molecularly imprinted polymer and the antibody inherently bind to different epitopes on the markers;
contacting the marker-bound antibody conjugate with conditions capable of releasing the detectable label from the amphiphilic lipid vesicle on the antibody - specifically, the reference teaches lysing the liposomes and releasing Cd (II) and Cu (II) ions (the detectable label) (pg. 30, col. 2, section 3.2.3 and Scheme 1);
detecting the detectable label - specifically, by using potentiometric striping analysis (PSA) (Abstract); and
wherein the capture molecule is affixed to the substrate comprises affixing to the substrate at the detector for the detectable label – the molecularly imprinted polymer (the capture molecule) is affixed to the electrode (the substrate and the detector for the detectable label).
Regarding claim 31, Johari-Ahar teaches the capture molecule is affixed to the substrate which is the detector for the detectable label. Specifically, the molecularly imprinted polymer is affixed to the surface of the gold electrode (Au-SPE)-based biosensor (Abstract). The gold electrode is the substrate and the detector.
Regarding claims 38 and 43, Johari-Ahar teaches Cd (II) and Cu (II) ions as the detectable label (pg. 28, col. 1, section 2.2.3), meeting the limitation of claims 38 and 43 reciting a metal ion in the ionic solution.
Regarding claim 52, Johari-Ahar teaches a gold electrode (Au-SPE)-based biosensor coated with a molecularly imprinted polymer (the capture molecule) affixed to the electrode (the substrate). The molecularly imprinted polymer is synthesized to have specificity toward two cancer biomarkers epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF) (Abstract and Scheme 1 - step with analytical sample added to the imprinted polymer).
EGFR and VEGF are the first and second markers of the instant invention.
The molecularly imprinted polymer is a planar polymer structure synthesized to have specificity toward two cancer biomarkers, wherein a polymer region surrounding each imprint of a biomarker can be considered as an independent capture molecule. Therefore, Johari-Ahar teaches both the first and second capture molecules.
Additionally, since Applicant fails to specifically disclose the properties and/or structures of the first and second substrates, one of ordinary skill in the art would find it obvious to consider a polymer region surrounding each imprint of a biomarker as a substrate, because this region not only specifically binds the biomarker, but also keeps the bound biomarker attached to the gold electrode. Therefore, Johari-Ahar teaches both the first and second substrates of claim 52.
The contacting and detection steps of claim 27 described above apply to the contacting and detection steps of claim 52.
The limitations of: wherein the first capture molecule is affixed to the first substrate or is capable of being affixed to the first substrate comprises affixing to the first substrate at the detector for the first detectable label, and wherein the second capture molecule is affixed to the second substrate or is capable of being affixed to the second substrate comprises affixing to the second substrate at the detector for the second detectable label are as described above for claim 27 – the molecularly imprinted polymer (the capture molecule) is affixed to the electrode (the substrate and the detector). The first and second detectable labels are Cd (II) and Cu (II) ions.
Regarding claim 193, Johari-Ahar teaches an antibody for the detection of a marker by a detector generating a detection signal. Specifically, the reference teaches an antibody AbVEGF conjugated to Cu (II)-filled liposomes, where Cu (II) cations are the detectable label (pg. 30, col. 2, section 3.2.3 and Scheme 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, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 106 is rejected under 35 U.S.C. 103 as being unpatentable over Johari-Ahar et al. (IDS; Biosens Bioelectron. 2018 Jun 1; 107:26-33), as applied to claims 27, 52 and 193 above, in view of Brand et al. (Clin Cancer Res. 2011 Feb 15;17(4):805-16), for reasons of record which are reiterated herein below.
The teachings of Johari-Ahar have been set forth above.
Johari-Ahar does not specifically teach detection of more than two markers.
Regarding claim 106, Brand teaches serum biomarker panels for the detection of pancreatic cancer (Title). Brand also teaches detection of more than two cancer biomarkers for screening for pancreatic cancer (Abstract).
Specifically, Brand teaches using a panel of 83 circulating biomarkers for the detection of pancreatic cancer. One of the biomarkers tested by Brand is EGFP (Table 2) also taught by Johari-Ahar (Abstract).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Johari-Ahar by employing additional cancer biomarkers as taught by Brand, in order to provide a method with improved sensitivity and specificity for the detection of pancreatic cancer (Brand, pg. 806, col. 2, par. 2). MPEP 2144.06 provides “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
The cancer biomarkers EGFR and VEGF taught by Johari-Ahar and the cancer biomarkers taught by Brand (Table 2) are functionally complimentary and their combination would have been expected to yield predictable results.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 27, 31 and 193 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,111,313, for reasons of record which are reiterated herein below.
Patent ‘313 recites a method for the detection of a target marker in a solution including charged ions and unrelated ions comprising:
providing a liposome in solution containing metal ions, the liposome including a detection antibody configured to bind a target marker - the metal ions are the means for amplifying the detection signal of instant claim 27 and the liposome including a detection antibody is an antibody or aptamer conjugate for the detection of a marker by a detector generating a detection signal comprising means for amplifying the signal of instant claim 193;
providing a field-effect transistor with a source-drain channel comprising a surface functionalized with both a capture antibody to selectively bind to the target marker and a metal ion chelator or metal ion derivatized chelator - the field-effect transistor is the detector of instant claim 27;
selectively binding the target marker to the detection antibody included with the liposome;
selectively binding the target marker to the capture antibody to dispose the target marker and bound liposome to the source-drain channel of the field-effect transistor - the capture antibody is the capture molecule of instant claim 27 and the field-effect transistor is the scaffold which is the detector for the detectable label of instant claim 31;
releasing the metal ions from the liposome - corresponds to contacting the marker-bound antibody or aptamer conjugate with conditions capable of releasing the detectable label from the amphiphilic lipid vesicle of instant claim 27;
selectively binding the metal ion chelator or metal ion derivatized chelator disposed on the functionalized surface of the source-drain channel with the metal ions released from the liposome; and
causing a change in current in the field-effect transistor as a result of the selective binding of the metal ion chelator or metal ion derivatized chelator with the metal ions released from the liposome without interference of the detection of the metal ions by screening oppositely charged ions and unrelated ions in the solution; and wherein the change in current is indicative of detection of the target marker - corresponds to
detecting the detectable label of instant claim 27.
This is a nonstatutory double patenting rejection.
Claims 52 and 106 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,111,313, in view of Johari-Ahar et al. (IDS; Biosens Bioelectron. 2018 Jun 1; 107:26-33) and Brand et al. (Clin Cancer Res. 2011 Feb 15;17(4):805-16), for reasons of record which are reiterated herein below.
Patent ‘313 recites a method for the detection of a target marker in a solution including charged ions and unrelated ions comprising:
providing a liposome in solution containing metal ions, the liposome including a detection antibody configured to bind a target marker;
providing a field-effect transistor with a source-drain channel comprising a surface functionalized with both a capture antibody to selectively bind to the target marker and a metal ion chelator or metal ion derivatized chelator;
selectively binding the target marker to the detection antibody included with the liposome;
selectively binding the target marker to the capture antibody to dispose the target marker and bound liposome to the source-drain channel of the field-effect transistor;
releasing the metal ions from the liposome;
selectively binding the metal ion chelator or metal ion derivatized chelator disposed on the functionalized surface of the source-drain channel with the metal ions released from the liposome; and
causing a change in current in the field-effect transistor as a result of the selective binding of the metal ion chelator or metal ion derivatized chelator with the metal ions released from the liposome without interference of the detection of the metal ions by screening oppositely charged ions and unrelated ions in the solution; and wherein the change in current is indicative of detection of the target marker.
‘313 does not specifically recite detecting two or more markers.
Johari-Ahar teaches detecting two cancer markers using a method similar to one of claim 1 of ‘313. Brand teaches more biomarkers for detecting cancer in addition to those taught by Johari-Ahar.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the detection method of ‘313 by employing two or more biomarkers as taught by Johari-Ahar and Brand, in order to provide a method with improved sensitivity and specificity for the detection of pancreatic cancer (Brand, pg. 806, col. 2, par. 2).
This is a nonstatutory double patenting rejection.
Terminal Disclaimer
The terminal disclaimer filed on June 20, 2025 has not been approved. Please, see Terminal Disclaimer review decision.
Response to Arguments
Applicant's arguments filed June 20, 2025 have been fully considered.
Applicant argues that “With regard to claim 38, the claim has been amended so that the claim no longer contains a Markush grouping of alternatives” (pg. 14, par. 5). Amended claims 38 and 43 are rejected as indefinite under 112(b) because they use the open “comprising” language.
Applicant argues that “a terminal disclaimer has been prepared and is submitted herewith” (pg. 15, par. 2). The terminal disclaimer filed on June 20, 2025 has not been approved. Please, see Terminal Disclaimer review decision.
Applicant argues that “Claims 27, 52, and 193 have also been amended to remove the relative term "near" and replaced with the term "at". Finally, claims 27, 52, and 193 have been amended to recite that the antibody or aptamer immobilizes the marker at the detector” (pg. 15, par. 7).
The argument is not persuasive because the term “at” is a relative term. It is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, claims 27, 52, and 193 are rejected above under 112(b).
Applicant argues that “With regard to claim 38, the claim has been amended to change its dependency to claim 27, thereby making it and dependent claim 43 complete” (pg. 16, par. 2). The argument is persuasive and claims 38 and 43 are no longer rejected as incomplete.
Applicant argues that “the Examiner also acknowledged within the office action that claim 32 was free of the prior art. Claim 27 has therefore been amended to include the subject matter of original claim 32. The Applicant therefore respectfully submits that since amended claim 27 contains subject matter acknowledged to be allowable, claim 27 itself is therefore allowable as well” (pg. 16, par. 6).
The argument is not persuasive because: (a) the original claim 32 was not identified as allowable, therefore including the subject matter of original claim 32 into claim 27 cannot make claim 27 allowable, and (b) it was claim 32 in its entirety that was indicated as free of the prior art, not the subject matter of original claim 32 included into claim 27. For example, “the scaffold adjacent to the detector” recited in original claim 32 makes it free of the prior art. The subject matter of original claim 32 included into claim 27 does not include this language and therefore the free of the prior art indication does not apply to amended claim 27.
Applicant argues that “With regard to claim 106, the claim is dependent on claim 52 and is therefore allowable on the same grounds above, which grounds are herein reasserted and for such additional limitations found therein” (pg. 17, par. 3). The argument is not persuasive for the reasons presented above in response #5.
Subject Matter Free of the Prior Art
Claim 33 is free of the prior art (see 112(a) and 112(b) rejections above for details).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexander Volkov whose telephone number is (571) 272-1899. The examiner can normally be reached M-F 9:00AM-5:00PM (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy Nguyen can be reached on (571) 272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER ALEXANDROVIC VOLKOV/Examiner, Art Unit 1677
/REBECCA M GIERE/Primary Examiner, Art Unit 1677