DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/12/26 has been entered.
Claim Rejections - 35 USC § 103
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.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fielder et al. (US 2017/0028141 A1, hereafter “Fielder”) in view of Jackson et al. (US 2013/0012858 A1, cited previously and hereafter “Jackson”).
As to claim 29, Fiedler discloses a method of treating diabetes-associated lipohypertrophy, comprising: encouraging injection site rotation by a diabetic patient implemented in a medicament delivery device or a separate device to reduce lipohypertrophy (see at least para 0005, 0020-0021, 0044, 0050, as well as Figs. 3-42 depicting various embodiments/means of encouraging patients to use different injection areas which can reduce lipohypertrohpy).
Fiedler is silent to applying an adhesive skin tensioning device to a skin location over a palpable lipohypertrophy site of a diabetic patient to reduce the progression of lipohypertrophy.
Jackson discloses applying an adhesive skin tensioning device (dressing 130, which is pre-strained by tensioning device 120 – see at least para 0144, 0156) to a skin location of a patient (abstract, para 0005) to reduce progression of various conditions found on/in skin (see para 0007), as well in underlying connective tissue layers, such as subcutaneous fat (see para 0099).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Fiedler, which already discusses concerns over lipohypertrophy and inducing lipodystrophic changes in a patient’s skin structure (e.g. in fatty tissue – see para 0006, 0085), by adding skin tensioning between/after injections. One would have been motivated to do so for the purpose of decreasing injection irritation and decrease complications (e.g. something that would likely result in less irritation and accumulation of fat due to the injection). The result of adding skin tensioning to the method of injection would help reduce the progression of lipohypertrophy by reducing irritation and/or changes in fatty tissue.
Response to Arguments
Applicant’s Remarks submitted 5/13/26 have been considered.
Applicant’s arguments regarding the previous Rejections under 35 U.S.C. § 112 are persuasive/moot based on the claim amendments. The previous rejections under 35 U.S.C. § 112 have been withdrawn,
Applicant’s arguments regarding the previous rejections under 35 U.S.C. § 103 were considered and while not necessarily persuasive, have been withdrawn in view of the claim amendments. The amendments though have prompted the new rejections above. The examiner makes a general argument that the instant claim 1 is merely using a known device/structure (i.e. a skin tensioning device such as that of Jackson) for a new use (i.e. treating of a known condition - lipohypertrophy). New uses of an old structure (e.g. a skin tensioning device) can be patentable (e.g. see MPEP 2112.02), but these are typically only allowed when the new use is unexpected. If the prior art of record suggests that skin tensioning has a benefit of improving the patient’s reaction to an injection that would logically apply to lipohypertrophy, then the rejection made above holds because that isn’t a discovery of a new property of skin tensioning during an injection absent unexpected results. The applicant notes in their Remarks that “the cited post-filing evidence of surprising results published in the Diabetes journal entitled A Weekly Tension Off-Loading Patch for Lipohypertrophy by DeVries et al., (Diabetes 2025;74(Supplement_1):817-P) the patient population was also patients with diabetes and palpable lipohypertrophy lesions“. However, the cited journal article does not explicitly discuss how results of the study are unexpected, nor does the applicant expand on why the results were unexpected, and therefore the claim is not allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/James D Ponton/Primary Examiner, Art Unit 3783
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