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 .
Response to Amendments
Applicant's amendments filed 9/08/2025 to claims 39, 41, 44, 46, 49, 51, 52, and 57 have been entered. Claims 1-38 and 50 are canceled. Claims 39-49 and 51-62 remain pending, of which claims 39-49 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 Claims 59-62 remain withdrawn from consideration.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.
The instant amendments to claim 39 and 41 have overcome the obviousness rejections of record over Picciolo, Irina, and Sangha. Those rejections are withdrawn.
Any objections and/or rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.
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 39-49, 51-54, 57, and 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 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 39-42, 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.
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.
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. 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.
Claims 55 and 56 are rejected under 35 U.S.C. 103 as being unpatentable over Birnboim, Irina, Sangha as applied to claim 39 above, and further in view of Plumb (US 7,298,886; provided in the IDS dated 6/21/2024).
The teachings of Birnboim, Irina, and Sangha are relied upon as set forth above.
Regarding claim 55, Birnboim, Irina, and Sangha does not teach wherein determining comprises: generating an image of the contacted sample by a camera. Regarding claim 56, Birnboim, Irina, and Sangha 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.
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 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 55 and 56
Regarding claims 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.
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.
Response to Arguments
Applicant's arguments on pages 5-11 of the reply have been fully considered, but not found persuasive of error for the reasons given below.
On pages 8-9 of the reply and again on page 10 of the reply, Applicant alleges that Birnboim is deficient by teaching SDS as a denaturing agent. This is not found persuasive because Birnboim is not applied alone, but in combination with Irina and Sangha, and the claimed invention becomes obvious when the references are considered together as a whole rather than each alone.
In response to applicant’s argument on page 9 of the reply that there is no teaching, suggestion, or motivation to combine the references, 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, the argument is not persuasive because 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. Absent any persuasive showing of nonobviousness to the contrary, “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”).
In response to applicant's argument on page 9 of the reply that Irina and Sangha “are not relevant to the present claims” and which is interpreted as an argument that Irina and Sangha are nonanalogous art, 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, Irina is analogous art by teaching methods for detecting analytes in biological samples (Abstract) such as urine and reading on the generic determining steps of claims 39 and 41, and Sangha is analogous art by teaching a (biological) specimen collection device and methods of use thereof (see the Abstract and also ¶0002).
On pages 9 of the reply, Applicant alleges that Birnboim, Irina, and Sangha are deficient by not individually teaching every element of claims 39 and 41. This is not found persuasive because Birnboim is not applied alone, but in combination with Irina and Sangha, and the claimed invention becomes obvious when the references are considered together as a whole rather than each alone. Furthermore, 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). In this case, none of Applicant’s arguments address what the combination of Birnboim, Irina, and Sangha would (or would not) suggest to a person of ordinary skill in the art.
Conclusion
No claims are allowed. No claims are free of the art.
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 mailing date of this final action.
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 7:00am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653