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
Applicant’s reply filed 9/2/25 is acknowledged. Claims 1-4 are pending and are under examination.
Response to Reply
Claim Objections
In light of applicant’s claim amendment, the prior objection of claim 1 is withdrawn.
Drawings
The drawings are objected to because in figs. 1, 2 and 5, the font is not clear; and for figs. 3a-3b the font and details of the 2 graphs are not clear. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
In light of applicant’s claim amendments, the prior rejection of claims 1-4 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn, except for the following below.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4 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.
The prior rejection of claim 1 is maintained because the claim contains the trademark, “BCIP”, which is not permitted in the claim because the metes and bounds are not constrained. Applicant must replace “BCIP” with generic terminology.
Claim Rejections - 35 USC § 101
In response to applicant’s arguments on p. 4-7 of the reply, the Office respectfully disagrees. The 101 rejection is maintained because the Office does not agree that claim 1 recites any elements which are significantly more than the abstract idea (Step 2B). According to MPEP 2106.05(a), the alleged improvement must be disclosed and the claim(s) be commensurate in scope with the asserted improvement. Here, the scope of the claim does not appear to reflect the disclosed improvement in the technology. Applicant’s arguments appear to be directed towards the background of the invention, and not to the current invention itself. For example, paragraph [0034] of the originally filed specification discloses what the abstract idea does but does not provide for an improvement over the prior art. Thus, the rejection is maintained.
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 1, for example, is an abstract idea because the claim recites in step, “b. drawing a standard curve” and in step “d. comparing the SERS signals obtained in step c with the standard curve.” The “drawing a standard curve” in step 1.b. is an abstract idea, and the “comparing” in step 1.d. is an abstract idea, because it is something that can be performed via pencil and paper. MPEP 2106.04(a)(2)(III) is clear that using a pencil and paper to perform the abstract idea does not preclude the steps from being considered an abstract idea. Also, given that the standard curve has a specific equation (see [0012] and [0019] of the instant specification), then the standard curve could also be considered a mathematical equation. This judicial exception is not integrated into a practical application because preparing the alkaline phosphatase samples, incubating with BCIP and then adding DMSO in step 1.a.; dropping standard solutions and conducting SERS in step 1.b.; and obtaining a sample from the seawater and adding DMSO to detect SERS in step 1.c. are all steps that are done to gather data that is then used in the abstract idea of comparing. Data gathering to be used in the abstract idea is insignificant extra-solution activity, and not a particular practical application. See MPEP 2106.05(g). The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the surface-enhanced Raman spectroscopy and surface-enhanced Raman scattering substrate are well-understood, routine and conventional. Furthermore, the scope of the claim does not appear to reflect the disclosed improvement in the technology.
Dependent claims all further refine the method steps and were considered, however, the subject matter does not affect the result established above.
Prior Art Rejection
In light of applicant’s claim amendments, the prior rejection is modified.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 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.
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 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Ruan et al. (“Ruan,” Detection of Alkaline Phosphatase Using Surface-Enhanced Raman Spectroscopy, 2006, previously cited) in view of Sebastián et al. (“Sebastián,” Alkaline phosphatase activity and its relationship to inorganic phosphorus in the transition zone of the North-western African upwelling system, 2004, previously cited) and Bornhop et al. (“Bornhop,” US Pub. No. 2013/0280715, previously cited).
As to claim 1, Ruan teaches a method for quantitatively detecting an alkaline phosphatase activity in a fluid based on surface-enhanced Raman spectroscopy (SERS in e.g., p. 3379, abstract), comprising the following steps:
a. preparing a plurality of alkaline phosphatase samples with different alkaline phosphatase activities (the fluid, bovine intestinal mucosa, includes a variety of enzymes, which include alkaline phosphatase; ALP Enzyme assays and Avidin Assays on p. 3380-3381), separately mixing and incubating each of the alkaline phosphatase samples with a 5-bromo-4-chloro-3-indolyl phosphate (BCIP) solution for a period of time to obtain mixed solutions (p. 3380-3381);
b. dropping the plurality of standard solutions with the different alkaline phosphatase activities onto a surface-enhanced Raman scattering substrate separately (see solutions and buffers section, and BCIP on p. 3380), conducting a SERS detection separately (see Results and Discussion section on p. 3381), and drawing a standard curve representing relations between intensity ratios of obtained SERS signals of the standard solutions to obtained SERS signal of the background (see p. 3381-3382 and fig. 2, which teaches a background curve (“standard curve”), and logarithm values of the background (see x-coordinate values of the background curve in fig. 2);
c. obtaining a sample to be tested from a solution (see e.g., bovine intestinal mucosa in experimental section on p. 3380), mixing the sample to be tested with a BCIP
solution (see Quantification of ALP on p. 3382) to obtain a test solution, and dropping the test solution onto a surface-enhanced Raman scattering substrate to directly detect SERS signals of the sample to be tested and the fluid (see experimental section on p. 3380-3381, which includes samples, solutions, buffers and assays); and
d. comparing the SERS signals obtained in step c with the background curve to determine the alkaline phosphatase activity of the sample to be tested (see p. 3381 and fig. 2, which teaches a background curve used as a comparison for the SERS signals).
Regarding claim 1, while Ruan teaches the method for detecting alkaline phosphatase in a fluid, Ruan does not specifically teach the alkaline phosphatase activity in seawater; and the values of the alkaline phosphatase activities of the standard solutions. Sebastián teaches seawater samples on p. 134 et seq. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to detect for alkaline phosphatase in seawater because it would be desirable to study the enzymatic activity of alkaline phosphatase in the transition zone between the African upwelling system and the open ocean waters of the Canary Islands region. (see abstract on p. 131 of Sebastián). Furthermore, Sebastián teaches values of standard solutions (see BSA standards on p. 135; latex beads was added as an internal standard on p. 135; a standard curve with MUF on p. 135). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to obtain the values of the activities of the standard solutions because it would verify the accuracy of the results.
Also, regarding claim 1, Ruan does not specifically teach adding a DMSO solution as a standard solution. Bornhop teaches adding DMSO in fig. 9 and [0230]. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include DMSO because it would be beneficial to utilize a commonly known analytical standard (e.g., [0230] of Bornhop).
As to claim 2, while Ruan teaches Raman shifts in figs. 1, 2, 4, 6 which include 677 cm-1 in the range, Ruan does not specifically teach selecting a peak intensity at a Raman shift of 677 cm-1. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process. MPEP 2144.05 II.B. Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to select the claimed Raman shift because it is a result-effective variable, and it would be desirable to select a peak intensity at a particular Raman shift to provide optimal results.
As to claim 3, see p. 3381 (second column), and p.3382 (first column) of Ruan.
As to claim 4, while the combination of Ruan in view of Sebastián and Bornhop teach fitted equations (see figs. 15, 16 and 25 of Bornhop), the combination of Ruan in view of Sebastián and Bornhop does not specifically teach the claimed fitted equation. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to utilize the claimed fitted equation because it would be beneficial to utilize an equation that optimizes the results.
Response to Arguments
Applicant's arguments filed 9/2/25 have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, specifically with regard to Ruan, 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). Here, it should be noted that Ruan does teach detecting ALP of a sample using BCIP and SERS, as explained in the abstract of Ruan.
In response to applicant’s argument regarding Sebastián, the Office respectfully disagrees. The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain. A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. See MPEP 2123(I) and (II). Here, Sebastián is a proper reference because Sebastián is relevant for showing how one skilled in the art can study alkaline phosphatase activity in seawater by taking water samples at discrete depths from the sea. Thus, the combination of Ruan and Sebastián is proper because persons skilled in the art would appreciate the teachings of Sebastián to improve Ruan’s method for detecting alkaline phosphatase activity.
In response to applicant’s arguments regarding Bornhop, the Office respectfully disagrees. 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, there is some teaching, suggestion, or motivation to modify Ruan with Bornhop because Bornhop specifically provides the teaching, suggestion, or motivation for one skilled in the art to add DMSO, which is because DMSO is a commonly known analytical standard (e.g., [0230] of Bornhop).
In response to applicant’s arguments regarding the ALP activity in seawater is quantitatively detected rapidly and accurately, e.g., yielding unpredictable results, the Office respectfully does not find applicant’s argument to be persuasive. Because Ruan, Sebastián and Bornhop teach optical detection methods to analyze samples, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to substitute or modify one method for the other to achieve the predicable result of detecting the activity of alkaline phosphatase. See MPEP 2143.02.
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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORE RAMILLANO JARRETT whose telephone number is (571)272-7420. The examiner can normally be reached Monday to Friday.
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/LORE R JARRETT/Primary Examiner, Art Unit 1797
11/28/2025