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 Application, Amendments, And/Or Claims
The Applicants amendments/remarks received 7/14/2026 are acknowledged. Claims 1-8, 10 and 12-15 are amended; claims 9, 11 and 16 are canceled; claims 1-8, 10 and 12-15 are pending; claims 3, 5-8, 12 and 14-15 are withdrawn; claims 1-2, 4, 10 and 13 will be examined on the merits.
Claim Objections
The objection to claim 1, as set forth at p. 3 of the previous Office Action, is withdrawn in view of the amendment of the claims.
Claim Rejections - 35 USC § 112(b)
The rejection of claims 1-2, 4, 10, and 13 under 35 U.S.C. § 112(b), as set forth at pp. 3-4 of the previous Office Action, is withdrawn in view of the amendment of the claims.
Claim Rejections - 35 USC § 101
The rejection of claims 1-2, 4, 10, and 13 under 35 U.S.C. § 101, as set forth at pp. 4-10 of the previous Office Action, is withdrawn in view of the amendment of the claims.
Claim Rejections - 35 USC § 103
The rejection of claims 1-2 and 4 under 35 U.S.C. § 103(a) over Lisboa et al., 2013 (NPL cite 1, IDS, 10/20/2022; herein “Lisboa”) in view of Newman et al., US2019/0142864 (cite A, PTO-892, 3/31/2025;herein “Newman”) as set forth at pp. 10-13 of the previous Office Action, is withdrawn in view of the amendment of the claims.
The rejection of claim 10 under 35 U.S.C. § 103(a) over Lisboa in view of Newman and Gethin, 2007 (NPL cite 3, IDS, 8/22/2025; herein “Gethin”) as set forth at pp. 13-14 of the previous Office Action, is withdrawn in view of the amendment of the claims.
The rejection of claim 13 under 35 U.S.C. § 103(a) over Lisboa in view of Newman, Percival et al., US 10739352 (cite B, PTO-892, 3/31/2025; herein “Percival”) and Bagga et al., 2016 (cite U, PTO-892, 1/16/2026; herein “Bagga”) as set forth at pp. 14-16 of the previous Office Action, is withdrawn in view of the amendment of the claims.
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.
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 1-2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Lisboa et al., 2013 (NPL cite 1, IDS, 10/20/2022; herein “Lisboa”) in view of Guo et al., 2010 (cite U, attached PTO-892 and Newman et al., US2019/0142864 (cite A, PTO-892, 3/31/2025;herein “Newman”).
Lisboa teaches investigating if patients with bilateral lower-extremity amputation (BLA) wounds exhibit differences in injury severity, physiologic and inflammatory response, bacterial burden, and wound-specific complications compared with patients with other combat-related extremity wounds (see Abstract and p.283, left column, 1st paragraph). Lisboa teaches detecting cytokines and chemokines and specifically detects eotaxin in wound exudate to indicate a local inflammatory response (see p.283, right column, 1st and 3rd paragraph, paragraph bridging p.288-289, and Figure 2B). Lisboa further teaches culturing fully ground, homogenized, wound tissue sample and detecting and counting the colonies grown (see Abstract, p.283, 2nd paragraph, p.284, right column, 1st paragraph, p.286, left column, 1st-2nd paragraphs, and Figs. 1C, 1E, 3). The wound tissue sample of Lisboa would be expected to comprise wound fluid as well, and the sample as recited is not limited to a wound fluid. Additionally, the specification at p.3, lines 19-22, states wound fluid is secreted by the wound and contains cells of the patient, and thus one of skill in the art would expect the wound tissue to comprise wound fluid. Lisboa further teaches critical colonization and inflammatory response are associated, and teaches that the levels of bacterial colonization and the levels of inflammatory markers were compared in patients with and without critical colonization, and thus teaches a comparison of the inflammatory and bacterial markers with predetermined concentrations (see p.286, left columns, 1st-2nd paragraphs, and Figs. 3 and 4). Thus, Lisboa teaches assessing the status of the wound based on the concentration of the inflammatory marker and bacterial colonization, wherein the status of the wound is assessed as being inflamed and as being colonized with metabolically active bacteria (see p.286, left column, 2nd paragraph).
Lisboa does not teach the one or more bacterial markers are selected from the group consisting of a coagulase, an enzyme, a metabolite, a siderophore, a signaling molecule, a virulence factor, and mixtures thereof; however, a person of ordinary skill in the art at the time of filing would have found it obvious for Lisboa to use nitrate reductase as the bacterial marker in view of the disclosure of Newman.
Newman teaches that nitrate reductase-containing bacteria can be found in infected skin wounds, and teaches methods to detect the nitrate reductase (an enzyme) of the bacteria and treat infection (see paras [0040]-[0041], [0055]-[0057], [0064], [0069], [0074], [0145]-[0149], [0206]). Newman further teaches the treatment comprises administering chlorate, antibiotics, and antimicrobials to the individual infected by nitrate reductase-containing bacteria (see paragraphs [0009]-[0012], [0019], [0079], [0108]-[0111], [0114], and [0207]).
Hence, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further tested the wound of BLA patients with critical bacterial colonization, as taught by Lisboa, for nitrate reductase containing bacteria by detecting the bacterial nitrate reductase and to have treated the patient by administering chlorate, antibiotics, and antimicrobials, as taught by Newman.
While the method of treating wounds made obvious by Lisboa in view of Newman clearly teaches administering an antibiotic, antiseptic, or both, to the patient and does not mention anti-inflammatory treatment, the disclosures do not specifically disclose whether to administer glucocorticoids or non-steroidal anti-inflammatory (NSAID) drugs if the wound is inflamed as determined with the inflammatory markers in the method made obvious by Lisboa in view of Newman; however, a person of ordinary skill in the art at the time of filing would have found it obvious to NOT treat inflamed wounds with glucocorticoids or NSAIDs if the wounds have an active infection in view of the disclosure of Guo.
Guo is drawn to factors that affect wound healing (Title). Guo teaches metabolically active infections in the wound inhibits wound healing (Table 2; p. 221, “Infections”). Guo teaches inflammation is a normal part of the wound healing process and is important to the removal of contaminating microorganisms of the infection in the wound (p. 221, “Infections”).
Guo teaches medications, glucocorticoid steroids and NSAIDs in particular, inhibit wound healing and increase the risk of infection in the wound (pp. 223-224, “Glucocorticoid steroids”, “Non-steroidal Anti-inflammatory Drugs”; Fig. 1); hence, a person of ordinary skill in the art at the time of filing would have found it obvious that if the wound has a metabolically active infection, then administering glucocorticoids or NSAIDs is disadvantageous because glucocorticoids and NSAIDs encourage bacterial colonization and interfere with the natural inflammatory process of removing contaminating microorganisms of the infection from the wound.
Hence, a person of ordinary skill in the art at the time of filing would have found it obvious to practice the method made obvious by Lisboa in view of Newman wherein when the measured concentration of the one or more inflammatory markers is below the predetermined concentration of the one or more inflammatory markers, indicating an inflammation within the wound, and the measured concentration of the one or more bacterial markers is below the predetermined concentration of the one or more bacterial markers, indicating the wound IS NOT colonized with metabolically active bacteria, then a glucocorticoid, a NSAID or both, is administered to the patient without an anti-bacterial treatment to treat the inflammation; and when the concentration of the one or more inflammatory markers is below the predetermined concentration of the one or more inflammatory markers, indicating an inflammation within the wound, and the concentration of the one or more bacterial markers is above the predetermined concentration of the one or more bacterial markers, indicating a colonization of the wound with metabolically active bacteria, then an antibiotic, antiseptic, or both is administered to the patient without an anti-inflammatory treatment because Guo discloses that glucocorticoids (GCs) and NSAIDs encourage bacterial colonization and interfere with the natural inflammatory process of removing contaminating microorganisms of the infection; thus, GCs and NSAIDs should NOT be administered when the wound has a metabolically active bacterial infection; therefore, claims 1-2 and 4 are prima facie obvious.
Response to Arguments
Applicant's arguments filed 7/14/2026 have been fully considered but they are not persuasive. Arguments of the Applicant’s Response on pp. 7-13 regarding the claim objection and the rejections under 35 U.S.C. § 112(b), 101 and 103 are moot as the rejections have been withdrawn. Regarding the rejection of claims 1-2 and 4 over Lisboa in view of Newman, Applicant argues that Lisboa in view of Newman does not disclose the method of the amended claims. This is correct; however, Lisboa in view of Guo and Newman as set forth above does make obvious claims 1-2 and 4 as set forth above.
Claims 1-2, 4 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Lisboa in view of Guo, Newman and Gethin, 2007 (NPL cite 3, IDS, 8/22/2025; herein “Gethin”).
The discussion of Lisboa, Guo and Newman regarding claims 1-2 and 4 as set forth in the rejection above is incorporated herein.
Regarding claim 10, Lisboa, Guo and Newman do not teach a step of determining a pH value of the sample, the pH value of the sample indicates a poorly healing or non-healing wound if the pH value is 7.1 or higher.
Gethin teaches that wound healing is a complex multifaceted process in which the pH of the wound can affect many factors including oxygen release, angiogenesis, protease activity, and bacterial toxicity (see Abstract). Gethin further teaches that chronic non-healing wounds have an elevated alkaline (i.e. above pH 7) environment and as they heal the pH gradually becomes acidic (see Abstract and paragraph bridging p.52-53, p.53, left column, 1st paragraph).
Hence, a person of ordinary skill in the art at the time of filing would have found it obvious to practice the method made obvious by Lisboa in view of Guo and Newman wherein the method further comprises a step of measuring a pH value of the sample, the pH value of the sample indicates a poorly healing or non-healing wound if the pH value is 7.1 or higher, because Gethin teaches that chronic non-healing wounds have an alkaline pH above 7.0; therefore, claim 10 is prima facie obvious.
Response to Arguments
Regarding the rejection of claims 1-2, 4 and 10 over Lisboa in view of Newman and Gethin, Applicant argues that Gethin, Percival, and Bagga do not cure the deficiencies of Lisboa and Newman. Lisboa and Newman are discussed on pp. 8-9 above. The rejection is modified to include Guo and to address amended claims and/or for clarity.
Claims 1-2, 4, 10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Lisboa in view of Guo, Newman, Gethin, Percival et al., US 10739352 (cite B, PTO-892, 3/31/2025; herein “Percival”) and Bagga et al., 2016 (cite U, PTO-892, 1/16/2026; herein “Bagga”).
The discussion of Lisboa, Guo, Newman and Gethin regarding claims 1-2, 4 and 10 as set forth in the rejection above is incorporated herein.
Regarding claim 13, Lisboa, Guo and Newman do not teach wherein the concentrations of the one or more inflammatory markers and the one or more bacterial markers are determined by a dipstick type test; however, a person of ordinary skill in the art at the time of filing would have found it obvious for the concentrations of the one or more inflammatory markers and the one or more bacterial markers are determined by a dipstick type test comprising one or more enzymes, antibodies, or dyes located on a dipstick test strip, where the one or more enzymes, antibodies, or dyes are able to detect the one or more inflammatory markers and the one or more bacterial markers in view of the disclosures of Percival and Bagga.
Percival teaches a method of diagnosing or predicting infections of a mammalian wound by detecting the presence of cytokines including eotaxin in wound fluid using an assay that generates a color change in a test strip (see Col. 2, lines 9-41, and Col. 3, lines 4-24).
Bagga teaches bacteria in urine produce the enzyme nitrate reductase which reduces nitrate to nitrite (see p.24, right column, 1st paragraph). Bagga further teaches the nitrite test detects the presence of nitrite in urine (see p.24, right column, 1st paragraph). Bagga discloses a dipstick test for nitrite (see Abstract, p.25, right column, 2nd paragraph, and Tables 1-4).
Hence, a person of ordinary skill in the art at the time of filing would have found it obvious to practice the method made obvious by Lisboa in view of Guo and Newman wherein concentrations of the one or more inflammatory markers and the one or more bacterial markers are determined by a dipstick type test comprising one or more enzymes, antibodies, or dyes located on a dipstick test strip, where the one or more enzymes, antibodies, or dyes are able to detect the one or more inflammatory markers and the one or more bacterial markers because Percival and Bagga demonstrate that the concentrations of eotaxin and nitrate reductase can be determined by such a dipstick-type test; therefore, claim 13 is prima facie obvious.
Response to Arguments
Regarding the rejection of claims 1-2, 4 and 13 over Lisboa in view of Newman, Percival and Bagga, Applicant argues (pp. 12-13) that Gethin, Percival, and Bagga do not cure the deficiencies of Lisboa and Newman. Lisboa and Newman are discussed on pp. 8-9 above. The rejection is modified to include Guo and to address amended claims and/or for clarity.
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.
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Claims 1-2, 4, 10 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, 11 and 14 of copending Application No. 17920087 (herein “’087”) in view of Stacey et al., 2019 (cite V, PTO-892, 3/31/2025; herein “Stacey”).
Claim 1 of ‘087 recites a method for treating a wound of a patient, comprising the steps of measuring a concentration of one or more inflammatory markers in a sample from the wound, wherein the sample comprises of wound fluid and the one or more inflammatory markers may indicate an inflammation within the wound, measuring a concentration of one or more bacterial markers in the sample, wherein the one or more bacterial markers may indicate a colonization of the wound with metabolically active bacteria, and administering a treatment to the patient, wherein administering the treatment consists of: a) administering a glucocorticoid, a non-steroidal anti-inflammatory drug (NSAID), or both, to the patient without an anti-bacterial treatment when the measured concentration of the one or more inflammatory markers in the sample is above a predetermined concentration and the measured concentration of the one or more bacterial markers in the sample is below a predetermined concentration; or b) administering an antibiotic, antiseptic, or both, to the patient without an anti-inflammatory treatment when the measured concentration of the one or more inflammatory markers in the sample is above a predetermined concentration and the measured concentration of the one or more bacterial markers in the sample is above a predetermined concentration; claim 3 of ‘087 recites the method of claim 1, wherein the one or more bacterial markers are selected from the group consisting of a coagulase, an enzyme, a metabolite, a siderophore, a signaling molecule, a virulence factor, and mixtures thereof; and claim 5 of ‘087 recites the method of claim 3, wherein the enzyme is alkaline phosphatase or nitrate reductase. Hence, claims 1, 3 and 5 of ‘087 disclose the method of instant claim 1 except that the claims of ‘087 do not recite that the one or more inflammatory markers can comprise glucose or eotaxin-1; however, a person of ordinary skill in the art at the time of filing would have found it obvious for eotaxin-1 or glucose to be the one or more inflammatory markers in view of Stacey.
Stacey teaches that glucose and eotaxin are biomarkers in wound fluid that can help predict the wound’s healing (see Abstract, p.512, right column, 2nd passage, and Table 3).
Hence, a person of ordinary skill in the art at the time of filing would have found it obvious to practice the method of claims 1, 3 and 5 of ‘087 wherein the one or more inflammatory markers comprises glucose or eotaxin-1 and wherein the indication of inflammation within the wound is when glucose or eotaxin-1 drops below a predetermined concentration (Table 3 – the concentrations of eotaxin-1 and glucose drop below the concentrations of healing wounds when the wound is inflamed and non-healing); therefore, instant claims 1-2 and 4 are prima facie obvious.
Regarding instant claim 10, claim 11 of ‘087 recites the method of claim 1, wherein the method further comprises a step of determining a pH value of the sample, wherein the pH value of the sample indicates a poorly healing or non-healing wound if the pH value is 7.1 or higher. Hence, a person of ordinary skill in the art at the time of filing would have found it obvious to practice the method made obvious by claims 1, 3 and 5 of ‘087 in view of Stacey wherein the method further comprises a step of determining a pH value of the sample, wherein the pH value of the sample indicates a poorly healing or non-healing wound if the pH value is 7.1 or higher; therefore, instant claim 10 is prima facie obvious.
Regarding instant claim 13, claim 14 of ‘087 recites the method of claim 1, wherein the measured concentrations of the one or more inflammatory markers and the one or more bacterial markers are determined by a dipstick type test comprising one or more enzymes, antibodies, or dyes located on a dipstick test strip, where the one or more enzymes, antibodies, or dyes are able to detect the one or more inflammatory markers and the one or more bacterial markers. Hence, a person of ordinary skill in the art at the time of filing would have found it obvious to practice the method made obvious by claims 1, 3 and 5 of ‘087 in view of Stacey wherein the method further comprises wherein the measured concentrations of the one or more inflammatory markers and the one or more bacterial markers are determined by a dipstick type test comprising one or more enzymes, antibodies, or dyes located on a dipstick test strip, where the one or more enzymes, antibodies, or dyes are able to detect the one or more inflammatory markers and the one or more bacterial markers; therefore, instant claim 13 is prima facie obvious.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Regarding the rejection of claims 1-2, 4, 10 and 13 on the ground of nonstatutory double patenting over copending application ‘087 in view of Stacey, as set forth on pp. 16-19 of the previous Office action, Applicant argues (Remarks, p. 13) that ‘087 is drawn to administering “an anti-inflammatory drug when the concentration of the one or more inflammatory markers is below the predetermined concentration. This is opposite to the 17/920,087 application, which discloses administering an anti-inflammatory drug when the measured the concentration of the one or more inflammatory markers is above the predetermined concentration.” A person of ordinary skill is not an automaton but a person with normal common sense and reasoning ability. Claim 1 of ‘087 is clear that an increase in the inflammatory markers listed in claim 2 indicates inflammation in the wound and Stacey is clear that a decrease below the normal level of glucose or eotaxin-1 indicates inflammation in the wound. A person of ordinary skill would be able to incorporate Stacey’s teaching that a decrease below the normal level of glucose or eotaxin-1 indicates inflammation in the wound into the method made obvious by claims 1, 3 and 5 by substituting “the measured concentration of the one or more inflammatory markers in the sample is below a predetermined concentration” for “the measured concentration of the one or more inflammatory markers in the sample is above a predetermined concentration” because a decrease below the normal level of glucose or eotaxin-1 is indicative of inflammation in the wound.
Thus, Applicant’s arguments are unpersuasive and claims 1-2, 4, 10 and 13 are provisionally rejected on the ground of nonstatutory double patenting over claims 1, 3, 5, 11 and 14 of ‘087 in view of Stacey.
Conclusion
No claims are allowed.
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 Trent R Clarke whose telephone number is (571)272-2904. The examiner can normally be reached M-F 10-7 MST.
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/TRENT R CLARKE/ Examiner, Art Unit 1651
/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651
