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 .
Claims 6 and 9 have been cancelled.
Applicant's arguments filed 1/6/2026 have been fully considered but they are not persuasive.
Election/Restrictions
Applicant’s election of the agent that is an antibody against IL-10 that inhibits IL-10 signaling to a wound site in the reply filed on 6/4/2025 and clarified in the reply filed on 8/18/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Agents that that antagonize the IL-10 receptor (IL-10R) have not been searched. See at least claims 1, 5, and 7.
Specification
The 1/6/2026 amendment to paragraph [0003] of the specification is acknowledged. Applicant is requested to verify that 10,000 bytes is the correct size of file 42960-326929 sequence listing_ST25. It is noted that a kilobyte is not equivalent to 1000 bytes. Furthermore, the size of the file listed on the 48/2022 Electronic Acknowledgement Receipt is 9311 bytes.
The disclosure is objected to because of the following informalities:
Paragraph [0097] of the specification contains an empty box that appears to be a placeholder for a Greek letter following the recitation “IL-1.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 10 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 10 has been amended to recite “increase a macrophage response at the wound site.” No basis has been pointed to for this amendment and none is apparent.
The claim constitutes new matter.
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.
Claim 10 is 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 10 is confusing in reciting “increase a macrophage response at the wound site.” The specification does not specifically define what “increase a macrophage response” includes or excludes. The metes and bounds of the claim cannot be determined. Clarification is requested.
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, 5, 7-8, and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Kielian (U.S. Patent Application Publication 2016/0158353, of record) in view of Hayouka et al. (U.S. Patent Application Publication 2019/0038701), Presta et al. (U.S. Patent Application Publication 2005/0101770), and Forster et al. (U.S. Patent Application Publication 2021/0214421).
Kielian discloses preventing and treating a biofilm infection by administering an IL-10 inhibitor or an IL-10 receptor inhibitor. Biofilm infections include those caused by bacteria, including Staphylococcus infection. The inhibitors can be any form of antibodies. Decreasing myeloid-derived suppressor cells (MDSCs) prevents or treats biofilm infection. See at least paragraphs [0011, 0017, 0020, 0022, 0043-0044, and 0046] and claims 1, 3, 11-13, and 33-34.
Hayouka et al. discloses that bacterial infections associated with biofilms include wounds associated with diabetes mellitus. See at least paragraph [0101]. Staphylococcus infections are disclosed. See at least paragraphs [0004 and 0099]
Presta discloses antibodies that specifically bind IL-10. Antibody fragments and humanized antibodies are disclosed. See at least abstract and claims 1-8. The antibodies can be administered at least for example topically. See at least paragraph [0118]. Treatment of diabetes and its symptoms is disclosed. See at least paragraphs [0112 and 0126].
Forster et al. (U.S. Patent Application Publication 2021/0214421) makes clear that those of ordinary skill in the art would have known how to formulate antibodies for topical administration to treat infections such as Staphylococcus infection. Hydrogels for use at on skin and at wound sites are disclosed. See at least abstract, claims, and paragraphs [0069-0072 and 0086].
It would have been obvious to topically administer an anti-IL-10 antibody (thereby decreasing IL-10 signaling) as taught by Presta et al. to a diabetic wound in a patient to prevent (see instant claim 11, wound not yet infected) or treat (see instant claim 12, wound infected) a biofilm infection as taught by Kielian and Hayouka et al. in the diabetic wounds. One would have been motivated to do so in order to provide new methods of treating diabetic wounds. Forster et al. makes clear that one of ordinary skill in the art would have known how to formulate antibodies for topical administration to treat infections at wound sites.
Claims 1, 5, 7-8, and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Kielian (U.S. Patent Application Publication 2016/0158353, of record) in view of Hayouka et al. (U.S. Patent Application Publication 2019/0038701), Presta et al. (U.S. Patent Application Publication 2005/0101770), and Forster et al. (U.S. Patent Application Publication 2021/0214421) as applied to claims 1, 5, 7-8, and 11-12 above, and further in view of Eming et al.
Kielian, Hayouka et al., Presta, and Forster et al. are applied as above. These references do not disclose the limitations of instant claim 10.
Eming et al. discloses that wound healing is accelerated in IL-10 deficient mice. The number of macrophages infiltrating the wound tissue was significantly increased in IL-10 deficient mice. The reference states that IL-10 can impede wound repair. See at least abstract and Figures 1 and 4.
The method of prevention and treatment suggested by the combination of Kielian, Hayouka et al., Presta, and Forster et al. as discussed above would have been expected to increase the number of macrophages infiltrating the wound tissue as administration of the IL-10 antibody would essentially provide IL-10 deficient mice as taught by Eming et al. This increase in macrophage infiltration would increase a macrophage response at the wound site as recited in instant claim 10. One would have been motivated to do so in order to provide new methods of treating diabetic wounds.
Claims 1-5, 7-8, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kielian (U.S. Patent Application Publication 2016/0158353, of record) in view of Hayouka et al. (U.S. Patent Application Publication 2019/0038701), Presta et al. (U.S. Patent Application Publication 2005/0101770) and Forster et al. (U.S. Patent Application Publication 2021/0214421) as applied to claims 1, 5, 7-8, and 11-12 above, and further in view of Rodgers et al. (U.S. Patent Application Publication 2012/0329729) and Brem et al. (U.S. Patent Application Publication 2003/0180259).
Kielian, Hayouka et al., Presta, and Forster et al. are applied as above. These references do not disclose the limitations of instant claims 2-4.
Rodgers et al. discloses that subjects with type II diabetes or adult onset diabetes can have diabetic ulcers or wounds. Diabetic wounds can be debrided where the debridement is followed by treatment for wound healing and potential infection. See at least paragraphs [0002, 0022 and 0033].
Brem et al. discloses that debridement would have been known to convert a chronic wound into an acute wound. See at least paragraphs [0048 and 0067].
It would have been obvious to use the method of prevention and treatment suggested by the combination of Kielian, Hayouka et al., Presta, and Forster et al. as discussed above in a subject with type II or adult onset diabetes having diabetic ulcers or wounds as suggested by Rodgers et al. (See instant claim 3.) Treatment with the IL-10 antibody could have followed debridement of the wound as taught by Rodgers et al. (See instant claim 4.) Treatment with the IL-10 antibody immediately following debridement would be within one day of appearance of the acute wound site. (See instant claim 2.) One would have been motivated to do so in order to provide new methods of treating diabetic wounds.
Applicant's arguments with respect to improper hindsight reasoning are not persuasive. Applicant may argue that the examiner's conclusion of obviousness is based on improper hindsight reasoning. However, "[a]ny judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant's disclosure, such a reconstruction is proper." In re McLaughlin, 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971). The art rejection analysis does not include knowledge gleaned only from applicant's disclosure.
The prior art when taken as a whole provides ample motivation and suggests the claimed methods.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Eldridge (U.S. Patent Application Publication 2006/0228384) makes clear that chronic wounds such as diabetic foot ulcers would have been known to have been associated with biofilms. Staphylococcus infection is disclosed. The reference discloses the advantages of administering biofilm inhibitors. See at least paragraph [0055].
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 MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
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