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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/17/2026 has been entered.
Claims 4, 6, and 9 have been cancelled. Claims 13-22 have been newly added.
The rejection of claims 1, 5, 7-8, and 11-12 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 (U.S. Patent Application Publication 2021/0214421) is withdrawn in view of the claim amendments to debridement.
The rejection of claims 1, 5, 7-8, and 10-12 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. is withdrawn in view of the claim amendments to debridement.
Applicant's arguments filed 6/26/2026 have been fully considered but they are not persuasive.
Election/Restrictions
Claim 21 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/4/2025.
Claim 21 is directed to administering an antibody that binds IL-10R. Applicant elected methods of administering antibodies that bind IL-10 itself and not its receptor.
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.
Claims 1-3, 5, 7-8, 10-20, and 22 are 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.
Claim 1 has been amended to be directed to a method of treating a wound site in a diabetic patient comprising: debriding the wound site to form a debrided wound site; and topically administering, within about one day of debriding the wound site, a therapeutically effective amount of an antibody or antigen-binding fragment thereof that specifically binds Interleukin-10 (IL-10).
By this amendment, applicant removed the previous limitation in claim 1 that what is being administered must inhibit interleukin-10 (IL-10) signaling to the wound site. See original claim 1 and 1/6/2026 version of claim 1. Removing this limitation is considered to be new matter. The specification indicates that if the antibody does not inhibit interleukin-10 (L-10) signaling, then the method will not be operable. Note that the IL-10 antibody of claim 1 is not required to be antagonistic or neutralizing.
In addition, there is no basis for debriding the wound site to form a debrided wound site; and topically administering within about one day of debriding the wound site. Claim 4 (now cancelled) depended upon claim 1 and recited the “method according to claim 1, comprising debriding the wound site and administering the therapeutically effective amount of the agent. This does not provide a disclosure of topically administering within about one day of debriding the wound site.
Applicant pointed to various paragraphs in Patent Application Publication 2024/0092886 in support. This is not agreed with. The only paragraph in the PGPUB disclosing debridement is paragraph [0104] and it does not disclose topically administering within about one day of debriding the wound site.
Original claim 4 depended upon any one of claims 1-3 where original claim 3 recited “administering the therapeutically effective amount of the agent within about day of appearance of the wound site.” This is not in reference to the debrided wound site but the original wound site in a diabetic patient.
Applicant’s response does not point to basis for the debridement limitations in current claim 1 in the context of dependent claim 10 as amended. No basis is seen for claim 10.
Claims 13-20 and 22 are not original claims. They were added by amendment on 6/17/2026. Claims 13-20 depend upon claim 1. Claim 22 is an independent claims. There is no basis for new claims 13-20 and 22 in paragraphs [0013-0015, 0028-0034, 0039, 0093-0098, and 0104] of the PGPUB. In particular, no basis is seen for the “single topical dose” recited in claims 13-14 and 22. The experimental results presented in Figures 4-6 and 19-25 do not disclose any debridement. Again, only paragraph [0104] discloses debridement and not in the context of the claim limitations of these claims, particularly claims 13-14 and 19-20 as they depend from claim 1. Note that claim 19 as written “further comprises” some unspecified action that results in “stimulating healing of the debrided wound site.” As written, the stimulated healing is not due to or a result of the topical administration of the antibody. Note that the assessment methods of claim 20 are not generally disclosed for use in the claimed methods of treatment. They were used in the experiments of the examples which used full thickness excisional wounds on the backs of mice. These wound tissues were harvested This disclosure cannot be extrapolated to support the general method of treatment now claimed.
The claims constitute new matter.
Claims 1-3, 7-8, 10-16, 18-20, and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for methods where IL-10 signaling as inhibited or neutralized by the antagonistic IL-10 antibody (see claims 5 and 17), does not reasonably provide enablement for all methods embraced by the claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Independent claims 1 and 22 are directed to treatment with a therapeutically effective amount of an IL-10 antibody. In the absence of a specific therapeutic effect, all aspects of treatment must be enabled.
The specification defines treatment as meaning “an alleviation of symptoms associated with a disorder or disease, or halt of further progression or worsening of those symptoms, or prevention or prophylaxis of the disease or disorder.” There is no evidence of record or reason to believe that administration of the claimed IL-10 antibodies will prevent or cure wounds or their underlying cause such as diabetes, particularly with a single topical dose as in claims 13-14 and 22.
Again, applicant removed the previous limitation in claim 1 that what is being administered must inhibit interleukin-10 (IL-10) signaling. The specification indicates that if the antibody does not inhibit interleukin-10 (L-10) signaling, then the method will not be operable. Note that the IL-10 antibody of claims 1 and 22 are not required to be antagonistic or neutralizing.
The scope of the claims is not enabled.
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 1-3, 7-8, 10-16, 18-20, and 22 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.
Claims 1, 3, and 22 recite administering a “therapeutically effective amount” but the specific therapeutic effect that must be achieved is not specified. It is noted that the limitation of “inhibiting IL-10 signaling” has been deleted from claim 1 and is not present in claim 22. See by comparison claims 5 and 17.
Claim 3 is confusing in requiring administration of the antibody within about one day of appearance of the wound site. This is considered to be the original wound site. This is in conflict with claim 1 which requires administration within about one day of debriding the wound site. If applicant intends two administrations at separate time points, the specification does not appear to disclose this. Clarification is requested.
Claim 19 is confusing in reciting a further step of stimulating healing of the debrided wound site without providing the positive, active steps that must be performed to achieve this goal.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The limitation in claim 7 is already present in claim 1. Claim 7 does not further limit the subject matter of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-3, 5, 7-8, 12-18, 20, and 22 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, of record), Eldridge (U.S. Patent Application Publication 2006/0228384, of record), Presta et al. (U.S. Patent Application Publication 2005/0101770, of record), Forster et al. (U.S. Patent Application Publication 2021/0214421, of record), Rodgers et al. (U.S. Patent Application Publication 2012/0329729, of record), and Brem et al. (U.S. Patent Application Publication 2003/0180259, of record).
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].
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].
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]. Presta et al. discloses neutralizing anti-human IL-10 antibodies. See at least Example VI at paragraph [0183]. See instant claim 17. Antibodies with high affinity and specific to IL-10 are disclosed. Binding to IL-10 at least 10 and preferably 50 times more than to an irrelevant antigen is considered to be specific. See at least paragraph [0102-0103]. See instant claim 18.
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].
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. Formulations may be applied in any suitable manner including wound dressings. See at least paragraphs [0002, 0022, 0031-0033, 0038].
Brem et al. discloses that debridement would have been known to convert a chronic wound into an acute wound. Brem et al. also discloses that wound healing can be assessed using digital photography. See at least paragraphs [0048 and 0066-0067].
It would have been obvious to topically administer an anti-IL-10 antibody (thereby decreasing IL-10 signaling, see instant claim 5) as taught by Presta et al. to a diabetic wound in a patient with type II or adult onset diabetes having diabetic ulcers or wounds as suggested by Rodgers et al. (see instant claim 2) to prevent (see instant claim 11, wound not yet infected) or treat (see instant claim 12, wound infected) a biofilm infection in diabetic wounds as taught by Kielian, Hayouka et al., and Eldridge. Rodgers et al. and Brem et al. make clear that debridement of such wounds would have been routine and that treatment of the prepared wound bed with a suitable therapeutic formulation immediately following debridement (meeting the limitations of immediately, see instant claim 14, and within about one day, see instant claims 1 and 22) and using a suitable dressing would have been routine. Presta et al. discloses antibodies meeting the limitations of claims 1, 5, 7-8, 17-18, and 22. 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. With respect to instant claims 13 and 22, the prior art discloses a single dose; however, as this claim uses “comprising” language, the claim does not exclude additional doses when dressings are changed. With respect to claim 20, Brem et al. discloses that it would have been routine to use digital photography to assess wound healing.
The prior art when taken as a whole provides ample motivation and suggests the claimed methods.
Conclusion
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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/Marianne P Allen/Primary Examiner, Art Unit 1647
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