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 .
Specification
The amended title has been received and is accepted.
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 29 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.
Claim 29 has been amended to recite “applying an adhesive skin tensioning device to a lipohypertrophy Remarks document filed 12/16/2025 states “lipohypertrophy is a subcutaneous lesion, e.g. below the skin, and therefore not in the skin” (page 5 of 12/16/25 Remarks). It follows then, that a “lipohypertrophy site” would be a subcutaneous site, and not a site on/in skin. The instant disclosure appears only to support the placement of adhesive skin tensioning devices on skin, and not subcutaneously. Placement of an adhesive skin tensioning device in a subcutaneous location, which is what is implied by amended claim 29, does not appear to find support in the disclosure as originally filed.
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 29 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 29 has been amended to recite “applying an adhesive skin tensioning device to a lipohypertrophy
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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 of this title, 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. 102(a)(1) as anticipated by Jackson et al. (US 2013/0012858 A1, hereafter “Jackson”) or, in the alternative, under 35 U.S.C. 103 as obvious over Jackson in view of Johansson et al. (non-Patent Literature, see references cited, hereafter referred to as “Johansson”).
As to claim 29, Jackson discloses a method of treating subcutaneous tissue (see para 0004, 0099), comprising: applying an adhesive skin tensioning device (dressing 130, which is pre-strained by tensioning device 120 – see at least para 0144, 0156) to a lipohypertrophy site of a diabetic patient (although Jackson does not expressly mention lipohypertrophy, the instant disclosure states “diabetes patients may develop scar tissue and/or lipohypertrophy at chronic injections sites. Lipohypertrophy is an increased formation of fat tissue that is thought to be a hypertrophic effect from chronic localized insulin injections on adipose cells… Typical infusion using insulin pumps involves the placement of a cannula or needle into the delivery site (e.g., abdomen, arms, buttocks, thighs) every few days. Over time, this can induce lipodystrophic changes in the skin and subcutaneous structure” (para 0008) - Jackson does mention that its device may be applied for preventing or influencing “diabetic skin” (para 0007) – therefore the examiner maintains that there may be scenarios where the device of Jackson is applied to a lipohypertrophy site, even if not necessarily the intent, when it is applied to a chronic injection site). Further, while Jackson does not expressly recite that the applying is done to reduce the progression of lipohypertrophy, this limitation appears to merely be a result of placing the adhesive skin tensioning device on skin and does not necessarily require any specific additional steps. Therefore, it follows, by applying the adhesive skin tensioning device of Jackson to a treatment, in particular to an area of “diabetic skin”, then one would be reducing the progression of lipohypertrophy (as suggested by the instant disclosure, the only thing required for reducing the progression of hypertrophy is providing strain to the tissue, which the device of Jackson does). Therefore, as best understood by the examiner, Jackson anticipates claim 29.
However, in the event that “reduc[ing] the progression of lipohypertrophy” requires some additional step and/or treating “diabetic skin” implies something other than lipohypertrophy, there is additional prior art (see below) that specifically discuss lipohypertrophy.
Johansson, an article titled “Imparied Absorption of Insulin Aspart From Lipohypertrophic Injection Sites”, teaches “Lipohypertrophy is a common side effect of subcutaneous insulin therapy” (page 1) and discusses how tissues affected by lipohypertrophy may be less effective at absorbing insulin (see “CONCLUSIONS” section).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have used the device/method of Jackson, which is already used to treat a variety of skin conditions (see at least para 0007 of Jackson), for reducing the progression of lipohypertrophy. One would have been motivated to do so based off of Johansson, to prevent low absorption of insulin and/or insulin analogous (see “RESULTS” and “CONCLUSIONS” sections of Johansson).
Response to Arguments
Applicant's arguments filed 12/16/25 have been fully considered.
With regard the arguments under the headings “Objections to the Specification” (page 4 of Remarks) and “Rejections under 35 U.S.C. § 112” (page 4 of Remarks), the arguments are moot/persuasive as the amended title has been accepted and claims 30 and 33 have been canceled.
With regard to the arguments under the heading “Rejection under 35 U.S.C. § 102” (pages 4-5 of Remarks), the arguments are not persuasive. The applicant points out how Jackson discloses general use of its tensioning device for “diabetic skin or wound conditions”, and how lipohypertrophy is a subcutaneous lesion. In response, the examiner notes several key points: 1) the claim is directed to “A method of treating subcutaneous tissue” (i.e. not specifically lipohypertrophy), 2) applicant’s own specifications states that “diabetes patients may develop scar tissue and/or lipohypertrophy at chronic injections sites. Lipohypertrophy is an increased formation of fat tissue that is thought to be a hypertrophic effect from chronic localized insulin injections on adipose cells… Typical infusion using insulin pumps involves the placement of a cannula or needle into the delivery site (e.g., abdomen, arms, buttocks, thighs) every few days. Over time, this can induce lipodystrophic changes in the skin and subcutaneous structure” (para 0008 of instant specification), and 3) based on the applicant’s disclosure and Remarks, the only thing that appears to actually be required for reducing the progression of lipohypertrophy is placement of a tensioning device on skin (in other words, even if lipohypertrophy is a subcutaneous lesion, the way the progression is reduced is by applying the device to skin). There is a possibility, as understood from the applicant’s disclosure/Remarks, that a person receiving treatment with a device like Jackson’s, may already have lipohypertrophy (for example a person receiving treatment for diabetic skin). In other words, treatment of lipohypertrophy using the device of Jackson may already be occurring, even if it is not the intent, simply because the device of Jackson is applied to skin. The claim is so generalized in terms of how the progression of lipohypertrophy is reduced that adhesive skin tensioning devices placed on skin for the purpose of treating other conditions provide the necessary steps to reduce the progression of lipohypertrophy.
With regard to the arguments under the heading “Rejection under 35 U.S.C. § 103” (pages 5-6 of Remarks), the arguments are not persuasive. The applicant argues how Jackson is directed to skin tensioning devices to facilitate healing from gross tissue trauma and “As a hormone or endocrine-based disease, it would not have been obvious to a person of skill in the art to select a hormone or endocrine-based disease for treatment via a mechanical treatment device. This is in addition to the fact that lipohypertrophy is a subcutaneous disease, not a skin disease or skin condition” (pages 5-6 of Remarks). The applicant also goes on to state how “both Jackson and Johansson are silent as to what the clinical effect of such mechanical therapy would be on a hormone/endocrine-based disease, and whether it would actually work” (page 6 of Remarks). The examiner notes that Jackson’s treatment of different conditions is not exclusive to conditions on the skin. Jackson states “The devices, dressings, kits and methods described herein may control or regulate the mechanical environment of a skin including but not limited to the mechanical environment of a wound. The devices, dressings, kits and methods described herein may also control or regulate the mechanical environment to ameliorate scar and/or keloid formation. The mechanical environment of skin may include stress, strain, or any combination of stress and strain. The control of a wound's mechanical environment may be active or passive, dynamic (e.g., by applying an oscillating stress) or static. The stresses and strains acting on the wound may involve the layers of the skin, such as the outer stratum corneum, the epidermis and dermis, as well as the underlying connective tissue layers, such as the subcutaneous fat” (para 0099 of Jackson, emphasis added). The applicant also makes Remarks concerning surprising results and “obvious to try” rationale. The arguments though, argue limitations that are narrower than the claim. The examiner reiterates that the only actual step required is application of an adhesive skin tensioning device on skin. Therefore, the examiner is still of the stance that it would have been prima facie obvious for one having ordinary skill in the art to place the known skin-tensioning device of Jackson (which is already know for treating a variety of skin and subcutaneous conditions), to treat conditions other those described by Jackson (e.g. other skin/subcutaneous conditions).
The examiner recommends amending the preamble to be specific to lipohypertrophy, amending the claim to address the rejections under 35 U.S.C. 112(a) and 35 U.S.C. 112(b) above by clarifying where the adhesive skin tensioning device is placed (e.g. is the adhesive placed on a skin surface or some other location), and adding limitations concerning how lipohypertrophy is detected and/or actually affected by the application of the adhesive skin tensioning device.
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 James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 9am-5pm.
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/James D Ponton/Primary Examiner, Art Unit 3783