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 .
Priority
The instant application is U.S. national phase of PCT/EP2021/060256, filed on 4/20/2021, and claims foreign priority to EP20171338.5, filed on 4/24/2020.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/23/2025 has been entered.
DETAILED ACTION
Applicant’s amendment submitted on 11/23/2025 is acknowledged. Claims 9, 11, and 16 are cancelled. Claims 1-8, 10, and 12-15 remain pending in the instant application. Claims 3, 5-8, 12, and 14-15 remain withdrawn pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention.
Claims 1-2, 4, 10, and 13 are the subject of this office action.
In view of Applicant’s amendment to claim 13 to recite the one or more inflammatory markers and the one or more bacterial markers, the 35 U.S.C. §112(b) rejection previously set forth in the Final Rejection mailed on 10/1/2025 is withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities: the preposition “in” recited before the limitation, or above predetermined concentrations, in lines 16 and 20 should be replaced with the preposition “at”. Appropriate correction is required.
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 1-2, 4, 10, and 13 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.
Claim 1 recites “wherein either step a) or step b) is performed on the patient” in the last line. Step a) recites “administering a glucocorticoid, a non-steroidal anti-inflammatory drug (NSAID), or both, to the patient without an anti-bacterial treatment when the wound status is assessed as being inflamed and not colonized with metabolically active bacteria”. Step b) recites “administering an antibiotic, antiseptic, or both, to the patient without an anti-inflammatory treatment when the wound status is assessed as being inflamed and colonized with metabolically active bacteria”. It is not clear what constitutes performing either step a) or b) on the patient. Step a) only requires the glucocorticoid, NSAID, or both, to be administered to the patient when the wound status is assessed as being inflamed and not colonized with metabolically active bacteria. Step b) only requires the antibiotic, antiseptic, or both, to be administered to the patient when the wound status is assessed as being inflamed and colonized with metabolically active bacteria. The step of assessing the status of the wound may indicate that the wound is both not inflamed and not colonized with metabolically active bacteria. Thus, it follows that the steps of administering in a) and b) are not always carried out. In these cases, it is not clear how either step a) or step b) is performed on the patient. Therefore, the limitation recited in the last line is indefinite.
Claims 2, 4, 10, and 13 are also rejected for being dependent on a rejected base claim and failing to remedy the issue set forth above.
Claim Rejections - 35 USC § 101
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 1-2, 4, 10, and 13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
The claims recite a method for assessing a status of a wound of a patient, comprising the steps of determining a concentration of one or more inflammatory markers selected from glucose and eotaxin-1 in a sample from the wound, wherein the sample comprises of wound fluid and the one or more inflammatory markers indicate an inflammation within the wound, determining a concentration of one or more bacterial markers in the sample, 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 indicate a colonization of the wound with metabolically active bacteria, assessing the status of the wound based on comparing the determined concentrations of the one or more inflammatory markers and the one or more bacterial markers with predetermined concentrations for the one or more inflammatory markers and the one or more bacterial markers, wherein the status of the wound is assessed as being inflamed if the one or more inflammatory markers are contained in the sample below predetermined concentrations or not inflamed if the one or more inflammatory markers are contained in the sample in or above predetermined concentrations, and as being colonized with metabolically active bacteria if the one or more bacterial markers are contained in the sample above predetermined concentrations, or not colonized with metabolically active bacteria if the one or more bacterial markers are contained in the sample in or below predetermined concentrations; and a) administering a glucocorticoid, a non-steroidal anti-inflammatory drug (NSAID), or both, to the patient without an anti-bacterial treatment when the wound status is assessed as being inflamed and not colonized with metabolically active bacteria; or b) administering an antibiotic, antiseptic, or both, to the patient without an anti-inflammatory treatment when the wound status is assessed as being inflamed and colonized with metabolically active bacteria, wherein either step a) or step b) is performed on the patient. The claims are directed to correlating the natural phenomenon of a concentration of the inflammatory markers glucose and/or eotaxin-1 and the concentration of one or more bacterial markers with the status of a wound, which is a natural process. This judicial exception is not integrated into a practical application because claim 1 recites elements that are considered to be insignificant extra-solution activity for data gathering, abstract mental steps, and steps that are well-understood, routine, and conventional in the relevant field. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements recited are directed to insignificant extra-solution data gathering activity.
With respect to claim 1, the step of “determining a concentration of one or more inflammatory markers selected from glucose and eotaxin-1 in a sample from the wound, wherein the sample comprises of wound fluid and the one or more inflammatory markers indicate an inflammation within the wound” is insignificant extra-solution data gathering activity. Moreover, Stacey et al. (Wound Repair and Regeneration, Mar. 2019, Vol. 27(5), p.509-518) provides evidence 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). Thus, this step is also well-understood, routine, and conventional in the relevant field. The step of “determining a concentration of one or more bacterial markers in the sample, 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 indicate a colonization of the wound with metabolically active bacteria” is insignificant extra-solution data gathering activity. Furthermore, Stacey provides evidence that protease levels and enzyme activity in wound fluid is detected (see Abstract, p.511, left column, 3rd passage, and p.513, right column, 1st paragraph). Newman teaches that nitrate reductase containing bacteria can be found in infected skin wounds and teaches methods to detect the nitrate reductase of the bacteria (see paras [0040]-[0041], [0055]-[0057], [0064], [0069], [0074], [0145]-[0149], [0206]). Thus, this step is also well-understood, routine, and conventional in the relevant field. The step of “assessing the status of the wound based on comparing the determined concentrations of the one or more inflammatory markers and the one or more bacterial markers with predetermined concentrations for the one or more inflammatory markers and the one or more bacterial markers, wherein the status of the wound is assessed as being inflamed if the one or more inflammatory markers are contained in the sample below predetermined concentrations or not inflamed if the one or more inflammatory markers are contained in the sample in or above predetermined concentrations, and as being colonized with metabolically active bacteria if the one or more bacterial markers are contained in the sample above predetermined concentrations, or not colonized with metabolically active bacteria if the one or more bacterial markers are contained in the sample in or below predetermined concentrations;” involves abstract processes that can be practically performed in the human mind. The steps of “ a) administering a glucocorticoid, a non-steroidal anti-inflammatory drug (NSAID), or both, to the patient without an anti-bacterial treatment when the wound status is assessed as being inflamed and not colonized with metabolically active bacteria; or administering an antibiotic, antiseptic, or both, to the patient without an anti-inflammatory treatment when the wound status is assessed as being inflamed and colonized with metabolically active bacteria, wherein either step a) or step b) is performed on the patient” do not require that anything is administered in the case of a wound not being inflamed and not being colonized by metabolically active bacteria. Therefore, the claimed invention comprises an embodiment that does not necessarily require administering anything to the patient. Thus, claim 1 is directed to correlating the natural phenomenon of a concentration of the inflammatory markers glucose and/or eotaxin-1 and the concentration of one or more bacterial markers selected from the group consisting of a coagulase, an enzyme, a metabolite, a siderophore, a signaling molecule, a virulence factor, and mixtures thereof with the status of a wound, which is a natural process, without significantly more.
Claim 2 recites “wherein the one or more bacterial markers are selected from the group consisting of a coagulase, an enzyme, and mixtures thereof.” This is insignificant extra-solution activity that is known in the art. Stacey provides evidence that enzyme activity in wound fluid is detected (see Abstract, p.511, left column, 3rd passage, and p.513, 1st paragraph). Newman teaches that nitrate reductase containing bacteria can be found in infected skin wounds and teaches methods to detect the nitrate reductase of the bacteria (see paras [0040]-[0041], [0055]-[0057], [0064], [0069], [0074], [0145]-[0149], [0206]). Thus, this step is also well-understood, routine, and conventional in the relevant field.
Claim 4 recites “wherein the enzyme is alkaline phosphatase or nitrate reductase,” which is directed to the natural phenomenon of correlating a level of an alkaline phosphatase or nitrate reductase to a status of a wound. Thus, claim 4 is directed to the natural phenomenon without significantly more. Additionally, US2019/0142864 to Newman et al. provides evidence that nitrate reductase containing bacteria can be found in infected skin wounds and teaches methods to detect the nitrate reductase of the bacteria (see paras [0040]-[0041], [0055]-[0057], [0064], [0069], [0074], [0145]-[0149], [0206]). Therefore, claim 4 is well-understood, routine, and conventional in the relevant field.
Claim 10 recites “wherein the method further comprises 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,” which is directed to the natural phenomenon of correlating a pH of the sample to a status of the wound. Thus, claim 10 is directed to the natural phenomenon without significantly more.
Claim 13 recites “wherein the concentrations of the one or more inflammatory markers and the one or more bacterial markers are determined by a dipstick type test,” which is insignificant extra-solution data gathering activity that does not add more to the judicial exception.
Therefore, the claimed invention is directed to the natural phenomenon of correlating a concentration of the inflammatory markers glucose and/or eotaxin-1 and the concentration of one or more bacterial markers selected from the group consisting of a coagulase, an enzyme, a metabolite, a siderophore, a signaling molecule, a virulence factor, and mixtures thereof with the status of a wound, which is a natural process. The additional elements recited in claim 1 do not amount to more than the judicial exception because the additional elements are directed to insignificant extra-solution data gathering activity and abstract ideas that are well-understood, routine, and conventional in the relevant field. Furthermore, the invention embraces embodiments that do not require administration of a therapeutic to the patient. The dependent claims do not recite anything that amounts to more than the exception because the additional claims are directed to the natural phenomenon, abstract ideas, or insignificant extra-solution data gathering activity.
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.
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. (Surgery, 2013, Vol. 154(2), p.282-290; of record in IDS filed 10/20/2022) in view of Newman et al. (US2019/0142864; of record).
Regarding claim 1, 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, administering a glucocorticoid, a non-steroidal anti-inflammatory drug (NSAID), or both to the patient, or administering an antibiotic, antiseptic, or both to the patient.
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]).
Therefore, 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, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to determine if the bacteria causing the critical colonization in BLA patients wounds is from nitrate reductase-containing bacteria in order to properly treat the infection by administering chlorate, antibiotics, and antimicrobials, which would yield predictable results.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lisboa et al. (Surgery, 2013, Vol. 154(2), p.282-290; of record in IDS filed 10/20/2022) in view of Newman et al. (US2019/0142864; of record), as applied to claims 1-2 and 4 above, and further in view of Gethin (Wounds, 2007, Vol. 3(3), p.52-56; of record).
Lisboa in view of Newman teach the invention of claim 1 as outlined in the rejection above.
Regarding claim 10, Lisboa 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).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have tested the pH of the wound for an alkaline environment, as taught by Gethin, in the BLA patient’s wounds, as taught by Lisboa in view of Newman, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to determine what state of healing the wound of the BLA patient is to further determine treatment actions, which would yield predictable results.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Lisboa et al. (Surgery, 2013, Vol. 154(2), p.282-290; of record in IDS filed 10/20/2022) in view of Newman et al. (US2019/0142864; of record), as applied to claims 1-2 and 4 above, and further in view of Percival et al. (US10,739,352; of record) and Bagga et al. (J. Bacteriol. Mycol. Open Access, 2016, Vol. 2(1), pp.24-26).
Lisboa in view of Newman teach the invention of claim 1 as outlined in the rejection above.
Regarding claim 13, Lisboa 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.
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).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have substituted testing for eotaxin with a color changing test strip, as taught by Percival, for the method of detecting eotaxin taught in Lisboa in view of Newman, to arrive at the claimed invention. One of ordinary skill in the art would have been substituting known methods of detecting eotaxin in wound fluid, which would yield predictable results. One of ordinary skill in the art would have had a reasonable expectation of success since the methods of Percival and Lisboa are performed using wound fluid.
Percival does not teach wherein the concentrations of the one or more bacterial markers are determined by a dipstick type test.
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).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have detected nitrate reductase-containing bacteria using the nitrite dipstick, as taught by Bagga, in the method of detecting nitrate reductase-containing bacteria taught by Lisboa in view of Newman, to arrive at the claimed invention. One of ordinary skill in the art would have been substituting a known technical method for detecting nitrate reductase producing bacteria, yielding predictable results. One of ordinary skill in the art would have had a reasonable expectation of success since the dipstick is utilized in a fluid sample and the wound sample of Lisboa is fully ground and homogenized.
Claims 1-2, 4, and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 17/920,087 to Smola et al. in view of Stacey et al. (Wound Repair and Regeneration, Mar. 2019, Vol. 27(5), p.509-518; of record).
The combination of co-pending claims 1, 3, 10, and 12 read on instant claim 1.
Co-pending claim 1 recites “[m]ethod for assessing a status of a wound of a patient, comprising the steps of (lines 1-2) determining a concentration of one or more inflammatory markers in a sample from the wound, wherein the sample comprises wound fluid and the one or more inflammatory markers may indicate an inflammation within the wound (lines 3-5), determining 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 (lines 6-8), and assessing the status of the wound based on the concentrations of the one or more inflammatory markers and the one or more bacterial markers, wherein the status of the wound is assessed as being inflamed or not inflamed and as being colonized with metabolically active bacteria or not colonized with metabolically active bacteria (lines 9-13).” Co-pending claim 1 does not recite the inflammatory markers are selected from glucose and eotaxin-1 as recited in instant claim 1. 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). It would have been obvious to determine a concentration of glucose and eotaxin in wound fluid to predict the wound’s healing trajectory.
Co-pending claim 3 recites “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 (lines 1-4).”
Co-pending claim 5 recites “wherein the enzyme is alkaline phosphatase or nitrate reductase (lines 1-2).”
Co-pending claim 10 recites “wherein the status of the wound is assessed by comparing the determined concentrations of the one or more inflammatory markers and the one or more bacterial markers with predetermined concentrations for the one or more inflammatory markers and the one or more bacterial markers (lines 2-6), the status of the wound may in particular be assessed as being inflamed if the one or more inflammatory markers are contained in the sample above predetermined concentrations (lines 7-9), and/or the status of the wound may in particular be assessed as being not inflamed if the one or more inflammatory markers are contained in the sample in or below predetermined concentrations (lines 10-12), and/or the status of the wound may in particular be assessed as being colonized with metabolically active bacteria if the one or more bacterial markers are contained in the sample above predetermined concentrations (lines 13-15), and/or the status of the wound may in particular be assessed as being not colonized with metabolically active bacteria if the one or more bacterial markers are contained in the sample in or below predetermined concentrations (lines 16-18).”
Co-pending claim 12 recites “wherein the method further comprises a step of assessing if an anti-inflammatory treatment and/or an antibacterial treatment of the wound is indicated or not based on the status of the wound (lines 1-4).”
Co-pending claim 14 recites “wherein the concentrations of the markers are determined by a dipstick type test (lines 1-2).”
This is a provisional nonstatutory double patenting rejection.
Claim 10 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 17/920,087 to Smola et al. in view of Stacey et al. (Wound Repair and Regeneration, Mar. 2019, Vol. 27(5), p.509-518; of record) and further in view of Gethin (Wounds, 2007, Vol. 3(3), p.52-56; of record).
Co-pending claim 11 recites “wherein the method further comprises a step of determining a pH value of the sample which may indicate a poorly healing or non-healing wound (lines 1-4).” Co-pending claim does not recite the pH value of the sample 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 become acidic (see Abstract and paragraph bridging p.52-53, p.53, left column, 1st paragraph). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have tested the pH of the wound for an alkaline environment, as taught by Gethin, to determine what state of healing the wound of the BLA patient is to further determine treatment actions, which would yield predictable results.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 11/23/2025 have been fully considered but they are not persuasive.
In Applicant’s Remarks, see p.6, 3rd paragraph,-p.7, 5th paragraph, Applicant argues that claim 1 requires that one of the newly recited administration steps (i.e., steps a) or b)) must always be performed, and therefore, the claimed invention integrates the natural phenomenon. Applicant further argues that none of the cited references teach when an anti-inflammatory treatment should be administered without an anti-bacterial treatment, and when an anti-bacterial treatment should be administered without an anti-inflammatory treatment. This is not found persuasive.
The newly recited claim limitation requiring that either step a) or step b) is performed on the patient is not clear, as discussed in the 35 U.S.C. 112(b) rejection set forth above. This is because a wound sample may not test as being inflamed or colonized with metabolically active bacteria, as recited in the assessment step in the claimed invention. It is not clear if steps a) or b) would still be required to be performed in the case where the wound sample does not test positive for inflammation or colonization. Thus, the claimed invention still embraces embodiments in which administration as claimed is not required. Therefore, the claimed invention embraces embodiments that do not integrate the natural phenomenon.
In Applicant’s Remarks, see p.8, 1st paragraph,-p.10, 1st paragraph, Applicant argues that none of the references, alone or in combination, teach or suggest when anti-inflammatory agents and antibacterial agents should not be co-administered, as the claimed invention requires. This is not found persuasive.
The combination of Lisboa and Newman render the claimed invention obvious. The specific limitation contested, i.e., administration of an antibiotic without an anti-inflammatory, is rendered obvious from Newman’s disclosure. Newman teaches that nitrate reductase-containing bacteria can be found in infected skin wounds, and teaches methods to detect the nitrate reductase 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]). 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, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to determine if the bacteria causing the critical colonization in BLA patients wounds is from nitrate reductase-containing bacteria in order to properly treat the infection by administering chlorate, antibiotics, and antimicrobials, which would yield predictable results. Therefore, the teachings of Lisboa in view of Newman only require that an antibiotic and not an anti-inflammatory is administered to the patient, reading on the claimed invention.
In Applicant’s Remarks, see p.10, 2nd paragraph, Applicant does not provide any specific arguments with regards to the double patenting rejection. Therefore, the double patenting rejection is maintained.
Conclusion
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/J.P.S./Examiner, Art Unit 1657