DETAILED ACTION
Status of the Claims
Claims 1-3, 5-8, 10-12, 14, 16-17, 19-23, and 35-36 are currently pending and examined herein.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112(b)
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 5, 10, and 22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 5 contains the trademark/trade names TWEEN and TRITON, claim 10 contains the trademark/trade name MITRA, and claim 22 contains the trademark/trade name SMRT.
Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade names are used to identify/describe commercially available detergents (TWEEN and TRITON), microsampling device (MITRA), and sequencing technology (SMRT), and, accordingly, the identification/description is indefinite.
Claim Rejections – 35 U.S.C. 103(a)
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.
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.
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:
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.
Bhattacharjee et al. and Rudge et al., and/or Spooner et al.
Claims 1-3, 6-8, 10-12, 14, 16-17, and 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over Bhattacharjee et al. (U.S. PGPub 2016/0281166 A1, cited in IDS of 10/31/2022) in view of Rudge et al. (U.S. PGPub 2013/0116597 A1, cited in IDS of 10/31/2022) and/or Spooner et al. (Bioanalysis, 2015, 7(6):653-659, cited in IDS of 10/31/2022).
Regarding claims 1(in part), 2-3, 14, and 16, Bhattacharjee discloses “methods and systems [that] can be used for detecting, predicting, screening and/or determining the presence, absence or predisposition of a genetic condition in a subject” as per [0078], including determining the presence or absence of gene mutation(s) in CFTR (e.g., in cystic fibrosis detection as per [0064], [0085], and/or [0131]) in a dried biological fluid sample from a subject (e.g., as per [0012]-[0015]) comprising:
(a) eluting a dried whole blood sample from a subject (e.g., as per [0012]-[0015], which “can be obtained by a needle prick … from the arm, the foot, the finger, or the heel of the subject” as per [0095]);
(b) extracting genomic DNA from the dried blood sample (e.g. isolating DNA from dried blood samples as per [0012]-[0015] including with the use of lysis buffer comprising Proteinase K as per [0107] and/or [0256]);
(c) generating a library comprising amplicons corresponding to a plurality of target segments of the sample CFTR nucleic acid (e.g., Bhattacharjee discloses in several places including [0107]-[0114] and the Examples the use of whole genome amplification/sequencing and/or whole exome sequencing, which would reasonably amplify all genes, including CFTR for cystic fibrosis detection, as specified in [0064], [0085], and/or [0131]); and
(d) detecting the presence or absence of at least one mutation in at least one of the amplicons in the library using high throughput massive parallel sequencing (e.g. as per [0028] and [0143]-[0157], including CFTR for cystic fibrosis detection, as specified in [0064], [0085], and/or [0131]).
However, it is noted that Bhattacharjee is silent on the limitation of using a dried whole blood sample eluted from an absorbent tip of a microsampling device, as set forth in claims 1-2.
Rudge teaches the use of absorbent tips (termed “absorbent probes” by Rudge) as the microsampling device (e.g. as per the Abstract and [0010], [0013], [0016], and Rudge claim 1).
Regarding claims 3 and 11, Rudge discloses collecting blood from finger pricks (e.g. as per Fig. 2) at volumes of 20 µL (e.g. as per the Abstract and [0010], [0013], [0016], and Rudge claim 1).
Note that regarding claim 10, which recites that the microsampling device are MITRA tips, it appears by comparing Rudge to Spooner that the tips used by Rudge are the same as those disclosed by Spooner, which are identified by Spooner as MITRA tips. It is also noted that Spooner states that the MITRA tips “were supplied by Phenomenex, Inc. (CA, USA; exclusive distributor for the Mitra™ microsampler, manufactured by Neotryx, LLC, CA, USA)”. In the event that they are not the same, they are incredibly similar, such that as per MPEP 2143(I)(B) and citing KSR, the rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art.
It would have been prima facie obvious to a person of ordinary skill in the art prior to the effective filing date of the application to use the absorbent tips as per Rudge in the screening method of Bhattacharjee in place of dried blood sample cards. One of ordinary skill in the art would have been motivated to do so since Rudge teaches that using such a tip would be “an improved method and apparatus for use in blood sampling that reduces or eliminates one or more … errors and difficulties” that includes those associated with dried blood spots on cards, as are used by Bhattacharjee, and specifically would avoid the “risk for collection of too much blood on the card” as per [0005] and would be amenable to automation, specifically noting that “the blood spots are placed on rectangular cards which are difficult to manipulate by automated equipment, thus requiring extensive, expensive and time consuming manual handling and processing” as per [0008]. Note that the absorbent tips of Rudge collecting 20 µL of blood (see above) falls within the volume in which Bhattacharjee is interested in collecting (e.g. as per [0103]).
One of ordinary skill in the art at the effective filing date would have had a reasonable expectation of success in practicing the invention as claimed, since it would merely require the substitution of a microsampling device with an absorbent tip as per Rudge for the dried blood spot samples as per Bhattacharjee, wherein Rudge explicitly teaches that their microsampling devices with absorbent tips “is suitable as a quantitative sampling tool for biological fluids, preferably blood” (e.g. as per [0010]).
Regarding claims 6-8, Bhattacharjee teaches the above, wherein the elution is performed in lysis buffer and Proteinase K for up to 15 minutes at 90ºC, up to 1 hour at 56ºC, or up to 16-18 hours at 56ºC, noting that the reference in [0107] teaches a wide range of temperatures and times and in accordance with MPEP 2144.05(I), in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.
Regarding claim 12, Bhattacharjee teaches the above, wherein about 100 ng to about 400 ng of genomic DNA is eluted (e.g. as per [0012]-[0015]).
Regarding claim 17, Bhattacharjee teaches the above, wherein the dried biological fluid sample is obtained from an individual exhibiting cystic fibrosis symptoms, or having a family history of cystic fibrosis or a CFTR mutation (e.g., as per [0085], [0085], and/or [0131]).
Regarding claim 19, Bhattacharjee teaches the above, wherein the plurality of target segments, together, span all coding and non-coding regions of the CFTR gene (e.g., as per [0131] and/or [0236]).
Regarding claims 20-21, Bhattacharjee teaches the above, wherein the plurality of target segments further span about 1000 nucleotides of a promoter region immediately upstream of the first exon of the CFTR gene and wherein the plurality of target segments further span about 200 to 350 nucleotides immediately downstream of the CFTR gene (e.g., whole genome sequence as per [0078] and/or [0152]-[0157]).
Regarding claims 22-23, Bhattacharjee teaches the above, wherein the high throughput massive parallel sequencing is performed using pyrosequencing, reversible dye-terminator sequencing, SOLiD sequencing, Ion semiconductor sequencing, Helioscope single molecule sequencing, sequencing by synthesis, sequencing by ligation, or SMRTTM sequencing and wherein the high throughput massive parallel sequencing involves a read depth approach (e.g. HiSeq 2500 as per [0175] or SOLiD as per [0149]).
Bhattacharjee et al., Rudge et al. and/or Spooner et al., and Qiagen
Claims 1-3, 5-8, 10-12, 14, 16-17, and 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over Bhattacharjee et al. (U.S. PGPub 2016/0281166 A1, cited in IDS of 10/31/2022) in view of Rudge et al. (U.S. PGPub 2013/0116597 A1, cited in IDS of 10/31/2022) and/or Spooner et al. (Bioanalysis, 2015, 7(6):653-659, cited in IDS of 10/31/2022), further in view of Qiagen (Genomic DNA Handbook, June 2015, cited in IDS of 10/31/2022).
Bhattacharjee in view of Rudge and/or Spooner is relied upon as above, however, it is noted that while the reference teaches a lysis buffer with Tris·Cl, EDTA, and non-ionic detergents (e.g. as per [0107], [0114], and [0258]), it is silent on guanidine hydrochloride, Tween® 20, and Triton® X-100, as set forth in claim 5.
Qiagen teaches lysis buffer G2 comprising Tris·EDTA, guanidine hydrochloride, Triton® X-100, and Tween® 20 (e.g. as per page 63), to be used with lysing cells in blood with Proteinase K (e.g. as per pages 22-24).
It would have been prima facie obvious to a person of ordinary skill in the art prior to the effective filing date of the application to perform the genetic screening as per Bhattacharjee in view of Rudge and/or Spooner using the lysis buffer as per Qiagen. One of ordinary skill in the art would have been motivated to do so since Qiagen’s lysis buffer is a commercially available buffer system designed to work with Proteinase K for lysing blood samples prior to genomic DNA extraction and purification (e.g. their kits “provide an easy, safe, and reliable method for the isolation of pure high-molecular-weight genomic DNA” as per Qiagen page 7) and Bhattacharjee teaches at [0107] that their methods “can use different lysis buffer compositions”.
One of ordinary skill in the art at the effective filing date would have had a reasonable expectation of success in practicing the invention as claimed, since the lysis buffer from Qiagen is commercially available and marketed to such bioscience researchers (e.g., graduate student, post-doc, etc.).
Bhattacharjee et al., Rudge et al. and/or Spooner et al., and Bedwell et al.
Claims 1-3, 6-8, 10-12, 14, 16-17, 19-23, and 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Bhattacharjee et al. (U.S. PGPub 2016/0281166 A1, cited in IDS of 10/31/2022) in view of Rudge et al. (U.S. PGPub 2013/0116597 A1, cited in IDS of 10/31/2022) and/or Spooner et al. (Bioanalysis, 2015, 7(6):653-659, cited in IDS of 10/31/2022), further in view of Bedwell et al. (U.S. 5,840,702, cited in IDS of 10/31/2022).
Bhattacharjee in view of Rudge and/or Spooner is relied upon as above, however, it is noted that the references are silent on the specific anti-cystic fibrosis treatment, as set forth in claims 35-36.
Bedwell teaches treatment of cystic fibrosis with aminoglycosides (e.g. as per the Abstract, Summary of the Invention, and Bedwell claims).
It would have been prima facie obvious to a person of ordinary skill in the art prior to the effective filing date of the application to treat the patient identified with cystic fibrosis as per Bhattacharjee in view of Rudge and/or Spooner using aminoglycosides as per Bedwell. One of ordinary skill in the art would have been motivated to do so since Bedwell teaches that such treatment is effective in suppressing premature stop-codon mutations in some forms of cystic fibrosis (e.g. as per the Summary of the Invention section in col. 3-4).
One of ordinary skill in the art at the effective filing date would have had a reasonable expectation of success in practicing the invention as claimed, since such drugs were commercially available and commonly used for cystic fibrosis therapy.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
11,473,144 B2
Claims 1-3, 6-8, 11-12, 14, 16-17, 19-23, and 35-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,473,144 B2 (the ‘144 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the rejected claims of the present invention would be anticipated and/or rendered obvious by the subject matter in the claims of the reference patent.
Regarding claim 1, the claims of the ‘144 patent disclose a method for detecting the presence or absence of at least one mutation in a patient sample cystic fibrosis transmembrane regulator (CFTR) nucleic acid comprising:
(a) eluting a dried biological fluid sample from an absorbent tip of a volumetric microsampling device by contacting the absorbent tip of the microsampling device with a lysis buffer and Proteinase K;
(b) extracting the sample CFTR nucleic acid from the[[a]] dried biological fluid sample eluted from the absorbent tip of a microsampling device;
(c) generating a library comprising amplicons corresponding to a plurality of target segments of the sample CFTR nucleic acid; and
(d) detecting the presence or absence of at least one mutation in at least one of the amplicons in the library using high throughput massive parallel sequencing (e.g., as per claim 1 of the ‘144 patent).
Regarding claim 2, the claims of the ‘144 patent disclose the above, wherein the dried biological fluid sample is dried plasma, dried serum, or dried whole blood (e.g., as per claim 2 of the ‘144 patent).
Regarding claim 3, the claims of the ‘144 patent disclose the above, wherein the dried biological fluid sample on the absorbent tip of the microsampling device is collected from a patient via fingerstick (e.g., as per claims 3 and 13 of the ‘144 patent).
Regarding claim 5, the claims of the ‘144 patent disclose the above, wherein the lysis buffer comprises guanidine hydrochloride, Tris-Cl, EDTA, Tween 20, and Triton X-100 (e.g., as per claim 1 of the ‘144 patent).
Regarding claim 6, the claims of the ‘144 patent disclose the above, wherein elution of the dried biological fluid sample is performed by contacting the absorbent tip of the microsampling device with the lysis buffer for up to 15 minutes at 90 0C (e.g., as per claim 10 of the ‘144 patent).
Regarding claim 7, the claims of the ‘144 patent disclose the above, wherein elution of the dried biological fluid sample is performed by contacting the absorbent tip of the microsampling device with Proteinase K for up to 1 hour at 56 °C (e.g., as per claim 10 of the ‘144 patent).
Regarding claim 8, the claims of the ‘144 patent disclose the above, wherein elution of the dried biological fluid sample is performed by contacting the absorbent tip of the microsampling device with Proteinase K for up to 16-18 hours at 56 0C (e.g., as per claim 10 of the ‘144 patent).
Regarding claim 11, the claims of the ‘144 patent disclose the above, wherein the sample volume of the microsampling device is no more than 10-20 µL (e.g., as per claim 4 of the ‘144 patent).
Regarding claim 12, the claims of the ‘144 patent disclose the above, wherein no more than 400 ng of genomic DNA is eluted from the absorbent tip of the microsampling device (e.g., as per claim 1 of the ‘144 patent).
Regarding claim 14, the claims of the ‘144 patent disclose the above, wherein the at least one mutation is selected from among a base change, a gene deletion and a gene duplication (e.g., as per claim 5 of the ‘144 patent).
Regarding claim 16, the claims of the ‘144 patent disclose the above, wherein the at least one mutation is associated with cystic fibrosis (e.g., as per claim 6 of the ‘144 patent).
Regarding claim 17, the claims of the ‘144 patent disclose the above, wherein the dried biological fluid sample is obtained from an individual exhibiting cystic fibrosis symptoms, or having a family history of cystic fibrosis or a CFTR mutation (e.g., as per claim 7 of the ‘144 patent).
Regarding claim 19, the claims of the ‘144 patent disclose the above, wherein the plurality of target segments, together, span all coding and non-coding regions of the CFTR gene (e.g., as per claim 8 of the ‘144 patent).
Regarding claim 20, the claims of the ‘144 patent disclose the above, wherein the plurality of target segments further span about 1000 nucleotides of a promoter region immediately upstream of the first exon of the CFTR gene (e.g., as per claim 8 of the ‘144 patent).
Regarding claim 21, the claims of the ‘144 patent disclose the above, wherein the plurality of target segments further span about 200 to 350 nucleotides immediately downstream of the CFTR gene (e.g., as per claim 8 of the ‘144 patent).
Regarding claim 22, the claims of the ‘144 patent disclose the above, wherein the high throughput massive parallel sequencing is performed using pyrosequencing, reversible dye-terminator sequencing, SOLiD sequencing, Ion semiconductor sequencing, Helioscope single molecule sequencing, sequencing by synthesis, sequencing by ligation, or SMRTTM sequencing (e.g., as per claim 9 of the ‘144 patent).
Regarding claim 23, the claims of the ‘144 patent disclose the above, wherein the high throughput massive parallel sequencing involves a read depth approach (e.g., as per claim 9 of the ‘144 patent).
Regarding claim 35, the claims of the ‘144 patent disclose the above, further comprising selecting the patient for treatment with an anti-cystic fibrosis therapeutic agent if at least one mutation in at least one of the amplicons in the library is detected (e.g., as per claim 12 of the ‘144 patent).
Regarding claim 36, the claims of the ‘144 patent disclose the above, wherein the anti-cystic fibrosis therapeutic agent is one or more agents selected from the group consisting of penicillin, amoxicillin, cephalosporins, macrolides, fluoroquinolones, sulfonamides, Tetracyclines, aminoglycosides, colistin, Amcinonide, Betamethosone diproprionate, Clobetasol, Clocortolone, Dexamethasone, Diflorasone, Dutasteride, Flumethasone Pivalate, Flunisolide, Fluocinolone Acetonide, Fluocinonide, Fluorometholone, Fluticasone propionate, Fluticasone propionate, Fluticasone propionate, Flurandrenolide, Hydroflumethiazide, aceclofenac, acemetacin, aspirin, celecoxib, dexibuprofen, dexketoprofen, diclofenac, etodolac, etoricoxib, fenoprofen, flurbiprofen, ibuprofen, indometacin, ketoprofen, mefenamic acid, meloxicam, nabumetone, naproxen, sulindac, tenoxicam, tiaprofenic acid, expectorants, antihistamines, cough suppressants, Dextromethorphan, hypertonic salines, dornase alfa, mucolytics, pancreatic enzymes, vitamin A, vitamin D, vitamin E, vitamin K, and supplements reduce stomach acid (e.g., as per claim 12 of the ‘144 patent).
11,486,005 B2
Claims 1-3, 6-8, 11-12, 14, 16-17, 19-23, and 35-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,486,005 B2 (the ‘005 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the rejected claims of the present invention would be anticipated and/or rendered obvious by the subject matter in the claims of the reference patent.
Regarding claim 1, the claims of the ‘005 patent disclose a method for detecting the presence or absence of at least one mutation in a patient sample cystic fibrosis transmembrane regulator (CFTR) nucleic acid comprising:
(a) eluting a dried biological fluid sample from an absorbent tip of a volumetric microsampling device by contacting the absorbent tip of the microsampling device with a lysis buffer and Proteinase K;
(b) extracting the sample CFTR nucleic acid from the[[a]] dried biological fluid sample eluted from the absorbent tip of a microsampling device;
(c) generating a library comprising amplicons corresponding to a plurality of target segments of the sample CFTR nucleic acid; and
(d) detecting the presence or absence of at least one mutation in at least one of the amplicons in the library using high throughput massive parallel sequencing (e.g., as per claim 1 of the ‘005 patent).
Regarding claim 2, the claims of the ‘005 patent disclose the above, wherein the dried biological fluid sample is dried plasma, dried serum, or dried whole blood (e.g., as per claim 2 of the ‘005 patent).
Regarding claim 3, the claims of the ‘005 patent disclose the above, wherein the dried biological fluid sample on the absorbent tip of the microsampling device is collected from a patient via fingerstick (e.g., as per claim 3 of the ‘005 patent).
Regarding claim 5, the claims of the ‘005 patent disclose the above, wherein the lysis buffer comprises guanidine hydrochloride, Tris-Cl, EDTA, Tween 20, and Triton X-100 (e.g., as per claim 1 of the ‘005 patent).
Regarding claim 6, the claims of the ‘005 patent disclose the above, wherein elution of the dried biological fluid sample is performed by contacting the absorbent tip of the microsampling device with the lysis buffer for up to 15 minutes at 90 0C (e.g., as per claim 4 of the ‘005 patent).
Regarding claim 7, the claims of the ‘005 patent disclose the above, wherein elution of the dried biological fluid sample is performed by contacting the absorbent tip of the microsampling device with Proteinase K for up to 1 hour at 56 °C (e.g., as per claim 5 of the ‘005 patent).
Regarding claim 8, the claims of the ‘005 patent disclose the above, wherein elution of the dried biological fluid sample is performed by contacting the absorbent tip of the microsampling device with Proteinase K for up to 16-18 hours at 56 0C (e.g., as per claim 6 of the ‘005 patent).
Regarding claim 11, the claims of the ‘005 patent disclose the above, wherein the sample volume of the microsampling device is no more than 10-20 µL (e.g., as per claim 8 of the ‘005 patent).
Regarding claim 12, the claims of the ‘005 patent disclose the above, wherein no more than 400 ng of genomic DNA is eluted from the absorbent tip of the microsampling device (e.g., as per claim 7 of the ‘005 patent).
Regarding claim 14, the claims of the ‘005 patent disclose the above, wherein the at least one mutation is selected from among a base change, a gene deletion and a gene duplication (e.g., as per claim 1 of the ‘005 patent).
Regarding claim 16, the claims of the ‘005 patent disclose the above, wherein the at least one mutation is associated with cystic fibrosis (e.g., as per claim 1 of the ‘005 patent).
Regarding claim 17, the claims of the ‘005 patent disclose the above, wherein the dried biological fluid sample is obtained from an individual exhibiting cystic fibrosis symptoms, or having a family history of cystic fibrosis or a CFTR mutation (e.g., as per claim 10 of the ‘005 patent).
Regarding claim 19, the claims of the ‘005 patent disclose the above, wherein the plurality of target segments, together, span all coding and non-coding regions of the CFTR gene (e.g., as per claim 12 of the ‘005 patent).
Regarding claim 20, the claims of the ‘005 patent disclose the above, wherein the plurality of target segments further span about 1000 nucleotides of a promoter region immediately upstream of the first exon of the CFTR gene (e.g., as per claim 13 of the ‘005 patent).
Regarding claim 21, the claims of the ‘005 patent disclose the above, wherein the plurality of target segments further span about 200 to 350 nucleotides immediately downstream of the CFTR gene (e.g., as per claim 14 of the ‘005 patent).
Regarding claim 22, the claims of the ‘005 patent disclose the above, wherein the high throughput massive parallel sequencing is performed using pyrosequencing, reversible dye-terminator sequencing, SOLiD sequencing, Ion semiconductor sequencing, Helioscope single molecule sequencing, sequencing by synthesis, sequencing by ligation, or SMRTTM sequencing (e.g., as per claim 15 of the ‘005 patent).
Regarding claim 23, the claims of the ‘005 patent disclose the above, wherein the high throughput massive parallel sequencing involves a read depth approach (e.g., as per claim 16 of the ‘005 patent).
Regarding claim 35, the claims of the ‘005 patent disclose the above, further comprising selecting the patient for treatment with an anti-cystic fibrosis therapeutic agent if at least one mutation in at least one of the amplicons in the library is detected (e.g., as per claim 21 of the ‘005 patent).
Regarding claim 36, the claims of the ‘005 patent disclose the above, wherein the anti-cystic fibrosis therapeutic agent is one or more agents selected from the group consisting of penicillin, amoxicillin, cephalosporins, macrolides, fluoroquinolones, sulfonamides, Tetracyclines, aminoglycosides, colistin, Amcinonide, Betamethosone diproprionate, Clobetasol, Clocortolone, Dexamethasone, Diflorasone, Dutasteride, Flumethasone Pivalate, Flunisolide, Fluocinolone Acetonide, Fluocinonide, Fluorometholone, Fluticasone propionate, Fluticasone propionate, Fluticasone propionate, Flurandrenolide, Hydroflumethiazide, aceclofenac, acemetacin, aspirin, celecoxib, dexibuprofen, dexketoprofen, diclofenac, etodolac, etoricoxib, fenoprofen, flurbiprofen, ibuprofen, indometacin, ketoprofen, mefenamic acid, meloxicam, nabumetone, naproxen, sulindac, tenoxicam, tiaprofenic acid, expectorants, antihistamines, cough suppressants, Dextromethorphan, hypertonic salines, dornase alfa, mucolytics, pancreatic enzymes, vitamin A, vitamin D, vitamin E, vitamin K, and supplements reduce stomach acid (e.g., as per claim 21 of the ‘005 patent).
Conclusion
No claims are allowed.
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/JEREMY C FLINDERS/
Primary Examiner, Art Unit 1684