DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/20/2026 has been entered.
Response to Amendments
Applicant's amendments filed 4/20/2026 to claims 39, 43, 44, and 57 have been entered. Claims 1-38, 41, 42, and 50 are canceled. Claims 39, 43-49, and 51-62 remain pending, of which claims 39, 40, 43-49, and 51-58 are being considered on their merits. Claims 59-62 remain withdrawn from consideration. References not included with this Office action can be found in a prior action. Any rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.
Claim Objections
Claim 40 is objected to because of the following informalities: “Cio” is likely a typo for “C10”. Appropriate correction is required.
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 for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 39, 40, 43-49, and 51-58 are rejected under 35 U.S.C. 103 as being unpatentable over Birnboim et al. (WO 2015/179976; provided in the IDS dated 6/21/2024), Irina et al. (US 2012/0165626A1; provided in the IDS dated 6/21/2024) and Sangha et al. (US 2016/0024559A1; provided in the IDS dated 6/21/2024) and Plumb et al. (US 7,298,886) and evidenced by the APHL article on AFB smear microscopy (2013, 67 pages; provided in the IDS dated 6/21/2024).
This rejection addresses the embodiment of methyl oleoyl taurate for claims 39-42.
Birnboim teaches a method determining the amount of M. tuberculosis in a sample, the method comprising 1) contacting sputum samples spiked with M. tuberculosis with a composition comprising 2% w/v SDS, 12.5 mM CDTA (i.e. a species of chelator; trans‐cyclohexylene‐1,2‐diamine‐N,N,N′,N′‐tetraacetate, PubChem CID 10213), 50 mM glycine at a pH of 10.5 (¶0076), 2) plating the samples treated in step (1) on to LB plates for colony counting (¶0076-0082), reading in-part on claims 39-42, the concentration ranges of claims 43, 44, and 50, the embodiment of CDTA as a chelator for claim 47, claim 49, and claim 53.
Birnboim teaches biological samples comprising urine (¶0028), reading on claims 39 and 41. Birnboim teaches adding citric acid, CDTA, EGTA or EDTA as chelating agents (¶0036), reading on the embodiment of a species of organic acid or salt thereof for claim 39 and reading on claims 45, 47, 48, and 51. Birnboim teaches that adding the clearance composition prior to processing the sample with acid-fast staining to determine the presence of mycobacterial disease by microscopy (e.g. bright field microscopy or fluorescent microscopy as evidenced by the APHL article at p2-12) (¶0007-0008, ¶0055 and ¶00108), reading on claim 54.
Regarding claims 57 and 58, claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure; see M.P.E.P. § 2111.04. In this case, claims 57 and 58 have been fully considered but only recite the intended outcome of the method of claim 39, and so Birnboim is reasonably presumed capable of meeting claims 57 and 58 absent any showing to the contrary.
Regarding claim 39, Birnboim does not teach generating an image of the contacted sample. Regarding claim 39-42, Birnboim does not teach the embodiment of methyl oleoyl taurate. Regarding claims 46 and 52, Birnboim does not teach a citric acid or salt thereof concentration of 300 mM to 1M. Regarding claim 55, Birnboim does not teach wherein determining comprises: generating an image of the contacted sample by a camera. Regarding claim 56 does not teach measuring a number of pixels that correlates to the bacteria in the image and correlating the number of pixels with a predetermined number of pixels to obtain the amount of bacteria in the sample.
Irina teaches methods for detecting analytes in biological samples (Abstract) such as urine (¶0009). Irina teaches contacting the biological sample to a detection device wherein the detection device comprising a layer of sodium methyl oleoyl taurate as an exemplary species of hydrophilic surfactant (¶0068), reading in-part on claims 39-42.
Sangha teaches a (biological) specimen collection device (Abstract). Sangha teaches adding at least one surfactant/detergent to the biological sample as a stabilizing agent to prevent degradation of the sample by microorganisms and enzymes (¶0182). Sangha teaches non-ionic detergents such as Triton X-100 and anionic detergents such as SDS and sodium methyl oleoyl taurate as equivalents (¶0184 and ¶0187-0189), reading on claims 39-42.
Plumb teaches a method of counting biological agents (e.g. microorganisms) on a bacterial growth plate utilizing an imaging system (Abstract). Plumb teaches scanning unit houses a 2-dimensional monochromatic camera for generating one or more images of inserted bacterial growth plate 24 and housing various illuminators for illuminating the front and back of the biological growth plate 24 during imaging and wherein the images are communicated to an external computer 22 for image analysis (Col. 7, lines 34-45), reading on the generating step of claim 39 and the camera of claim 55. Plumb teaches that the colonies are defined by pixels in the images wherein small area colonies are defined as below a threshold of about 20 pixels or about 5 pixels (Col. 14, lines 33-41), reading on claims 55 and 56. Plumb teaches that scanning unit 21 may comprise a display screen to display the progress or results of analysis of the biological growth plate to a user (Col. 7, lines 22-33). Plumb teaches that the imaging system would be advantageous to improve the accuracy of automated counts of biological agents (e.g. microorganisms) on growth plates (Abstract, Col. 4, lines 46-53), reading on claims 39, 55 and 56.
Regarding claims 39, 55 and 56, it would have been obvious before the invention was filed to add the imaging system and display of Plumb to the bacterial detection methods of Birnboim. A person of ordinary skill in the art would have had a reasonable expectation of success in doing so because both Birnboim and Plumb are directed towards methods of detecting bacteria by counting colonies on growth plates. The skilled artisan would have been motivated to do so because Plumb teaches that the addition of the imaging system would be advantageous to automate the counting methods of Birnboim and to improve the accuracy of automated counts of biological agents (e.g. microorganisms) on growth plates.
Regarding claims 39-42, a person of ordinary skill in the art would have had a reasonable expectation of success in substituting the SDS of Birnboim for the sodium methyl oleoyl taurate of Sangha because SDS and sodium methyl oleoyl taurate are both explicitly taught as being useful for THE SAME PURPOSE as detergents in methods off measuring/quantifying the amount of bacteria in a sample. Furthermore, a person of ordinary skill in the art would be specifically directed towards the embodiment of sodium methyl oleoyl taurate of Sangha in view of Irina, who teaches sodium methyl oleoyl taurate is an exemplary hydrophilic surfactant in similar methods of detecting analytes in biological samples. Therefore, these compositions are functional equivalents in the art, and substituting one for the other would have been obvious at the time of the invention. “When a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.” See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) at 1395-1396, quoting Sakraida v. AG Pro, Inc., 425 U.S. 273 (1976) and In re Fout, 675 F.2d 297, 301 (CCPA 1982) (“Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious”).
Regarding claims 46 and 52, optimization within prior art conditions or through routine experimentation will generally not support patentability absent a showing of criticality of the claimed range to the contrary. See M.P.E.P. § 2144.05, particularly subsections II and III. In this case, Birnboim teaches an effective chelator concentration of 12.5 mM and that CDTA and citric acid both act as chelators, and so the burden is shifted back to establish criticality of the claimed surfactant/detergent concentration range by objective evidence.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the invention was filed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 39, 40, 43-49, and 51-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 8-10, 13-20, 24, 25, 29, 30, 36, and 37 of U.S. Patent No. 12,031,174 (Reference A).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 3, 4, 36, and 37 of the ‘174 patent are coextensive to the method of instant claim 39 which recites a method of measuring an amount of bacteria in a biological sample, the method comprising: contacting the biological sample with an aqueous clearance solution comprising a surfactant comprising 1) a fatty acid amide derivative of N-methyltaurine or a salt thereof, or 2) the fatty acid is a monounsaturated or polyunsaturated C10-C22 fatty acid, wherein the clearance solution further comprises an organic acid or a salt thereof; generating an image of the contacted sample; and determining the amount of bacteria in the sample. The sodium methyl oleoyl taurate (i.e. PubChem CID: 23664721) of claim 37 of the ‘174 patent and being claimed as a species of monosaturated or polysaturated C10-C22 surfactant reads on the broader embodiment of a fatty acid amide derivative of N-methyltaurine or a salt thereof for instant claim and the monounsaturated or polyunsaturated C10-C22 fatty acid of instant claim 40.
For clarity of the record, the structure of sodium methyl oleoyl taurate is reproduced below (from its PubChem CID entry):
PNG
media_image1.png
235
480
media_image1.png
Greyscale
Claims 8-10 of the ‘174 patent read on instant claims 43 and 44. Claims 13-15 of the ‘174 patent read on instant claims 45-47 and 52. Claim 18 of the ‘174 patent reads on instant claim 48 and 51. Claim 19 of the ‘174 patent reads on instant claim 49. Claims 24 and 25 of the ‘174 patent read on instant claims 53 and 54. The camera and correlation steps of claims 1 and 36 of the ‘174 patent read on instant claims 55 and 56. Claims 29 and 30 of the ‘174 patent read on instant claims 57 and 58.
Response to Arguments
Applicant's arguments on pages 6-11 of the reply have been fully considered, but not found persuasive of error for the reasons given below.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references on pages 7-8 of the reply regarding Birnboim and on pages 8-10 of the reply regarding Sangha, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, In this case, Applicant appears to be alleging Birnboim is defective by allegedly being directed towards stabilizing and maintaining the viability of the microorganisms and Sangha is deficient by teaching detergents for the purpose of promoting protein solubilization, membrane disruption, and cell permeabilization, thereby protecting a biological sample from degradation from microorganisms and enzymes. This is not found persuasive because 1) Applicant is alleging error over Birnboim and Sangha alone when the modified rejection above is over Birnboim in view of Irina, Sangha, and Plumb; one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986), and 2) Applicant has not shown by any preponderance of evidence that the embodiment of sodium methyl oleoyl taurate (SMOT) for the fatty acid amide derivative of N-methyltaurine or a salt thereof for claim 39 and the monounsaturated or polyunsaturated C10-C22 fatty acid of claim 40 and as taught by Irina and Sangha otherwise yields an unexpected result in the claimed methods relative to Birnboim; see M.P.E.P. § 716.02.
In response to applicant's argument that Irina is nonanalogous art on page 9 of the reply, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the argument is not persuasive because Irina teaches sodium methyl oleoyl taurate is an exemplary hydrophilic surfactant in similar methods of detecting analytes in biological samples and so is both analogous art to the claimed methods and is also reasonably pertinent to the particular problem with which the inventor was concerned.
On page 10 of the reply, Applicant appears to refer to an affidavit or declaration filed in the prior application. Affidavits or declarations, such as those submitted under 37 CFR 1.130, 1.131 and 1.132, filed during the prosecution of the prior application do not automatically become a part of this application. Where it is desired to rely on an earlier-filed affidavit or declaration, the applicant should make the remarks of record in this application and include a copy of the original affidavit or declaration filed in the prior application.
Conclusion
No claims are allowed. No claims are free of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at 571-272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Sean C. Barron/Primary Examiner, Art Unit 1653
Prosecution Insights