DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office Action is in response to the paper filed 25 February 2026. Claim 52 has been amended. Claims 54-56 have been cancelled. Claims 52, 53, and 57-60 are currently pending and under examination.
This application is a U.S. National Phase Application of PCT International Application No. PCT/US2019/050655, filed September 11, 2019, and claims benefit of priority to U.S. Provisional Application No. 62/738253, filed September 28, 2018.
New/Modified Rejections Necessitated by Amendment:
Claim Rejections - 35 USC § 112
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 52, 53, and 57-60 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 52 recites the limitation "the scaffold" in line 5. There is insufficient antecedent basis for this limitation in the claim. No scaffold is previously recited.
Further regarding claim 52, as amended this claim recites the limitation “wherein the isolation of the ECM or ECM protein is performed such that the scaffold maintains its structural and chemical integrity”; this limitation is indefinite, because it is unclear what “the scaffold” is intended to refer to. Further, if this limitation is intended to indicate that the ECM maintains its structural/chemical integrity, it is unclear how this is intended to be done when filtration, centrifugation, immune conjugation, or scrapping the ECM proteins are also intended to be performed. For the purposes of examination, performance of filtration, centrifugation, immune conjugation, or scrapping the ECM proteins as claimed is deemed to be performing isolation of the ECM/ECM proteins such that the scaffold maintains its structural and chemical integrity.
Lastly regarding claim 52, as amended, this claim recites in relevant part:
wherein the wound is a partial thickness wound, a full thickness wound, a surface wound, or an internal wound;
wherein the wound is skin damage, an abrasion, a contusion, a burn, an incision, a laceration, a penetration wound, a puncture wound, a sore, or an ulcer; and
wherein the ulcer is a diabetic ulcer, a venous ulcer, a chronic ulcer, or a pressure ulcer.
As currently written, these limitations are indefinite, because it is unclear which, if any, of these conditions are required to be met, as they can be mutually exclusive. For example, partial and full thickness wounds usually refer to burns, skin damage would not be an internal wound, and skin damage, an abrasion, a contusion, a burn, an incision, a laceration, a penetration wound, a puncture wound, or a sore, do not have to be a diabetic ulcer, a venous ulcer, a chronic ulcer, or a pressure ulcer. For the purposes of examination, this limitation is interpreted as requiring at least one of the noted conditions to be met.
Claims 53 and 57-60 are included in this rejection, as these claims depend from above rejected claim 52, and fail to remedy the noted deficiencies.
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.
Claims 52, 53, and 57-60 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (IDS; US 2015/0337261, Published 2015), and further in view of Rahmo (US 2016/0122708, Published 2016 – Previously Presented).
With regard to claims 52 and 53, Li et al. teach a method of treating a wound by contacting the wound with a composition comprising stem cell extracellular matrix (ECM) (Abs.; Para. 28; claim 29). The composition is administered to treat tissues including skin (Para. 33; claim 29, 35), wherein application to skin is topical application. The composition may also be applied by injection into a person for wound healing (Para. 28), which indicates that the wound is an internal wound. The ECM is isolated or purified using standard methods, including centrifugation (Para. 29), wherein centrifugation is an isolation method claimed by applicant, and is deemed to be performing isolation the ECM/ECM proteins such that a/the scaffold maintains its structural and chemical integrity.
Li et al. do not specifically teach that the stem cell ECM is small mobile stem (SMS) cell ECM.
Rahmo teaches the treatment of tissue and organ damage in a subject using SMS cell products, wherein SMS cells have an extraordinary ability to form complex multicellular macrostructures, and also heavily excrete ECM, which makes these cells amenable for medical applications (Abs.; Para. 20-21, 29).
It would have been obvious to one of ordinary skill in the art to combine the teachings of Li et al. and Rahmo, because both teach the treatment of tissues using stem cells and their produced components. The use of SMS cells for the production of ECM and treatment of tissues and organs is known in the art as taught by Rahmo. The use of SMS cell ECM as taught by Rahmo, as the stem cell ECM in the method of Li et al., amounts to the simple substitution of one known stem cell ECM for another, and would have been expected to predictably and successfully provide an alternative know stem cell ECM. Further, the use of SMS cells to provide the stem cell ECM would have also been expected to predictably improve the method of Li et al., as it is known from the teachings of Rahmo, that SMS cells have an extraordinary ability to form complex multicellular macrostructures, and also heavily excrete ECM, which makes these cell amenable for medical applications, such as would healing as desired by Li et al.
With regard to claim 57, taken together, Li et al. and Rahmo render obvious the method as claimed, including the components as claimed. As these components cannot be separated from their functions, treating a wound as taught by Li et al. and Rahmo would necessarily provide the results of promoting full thickness or partial thickness repair, accelerating wound healing, promoting wound closure, causing wound regression, increasing epithelialization, increasing epithelial layer thickness, increasing granulation, increasing granular layer thickness, increasing collagen deposition, increasing capillarization, enhancing vascularization, enhancing immune modulation, enhancing cell migration, enhancing cell growth, or any combination thereof.
With regard to claims 58 and 59, Li et al. teach that the ECM is cross-linked, including by the use of a chemical crosslinking agent (Para. 35).
With regard to claim 60, Li et al. teach that the ECM can be applied or implanted so that it directly contacts existing tissue adjacent to or defining the site of tissue damage, or the ECM can directly contact another implant (Para. 35). As the ECM may be applied by contacting another implant, it would have been obvious to one of ordinary skill in the art that an implant, which is a wound dressing, can be contacted by the ECM, and then used to place the ECM in contact with the wound of the subject.
Response to Arguments
Applicant urges that Li utilizes an altered ECM with numerous steps and not ECM where the structural and chemical integrity have been maintained. Additionally, Rahmo does not teach that the SMS cell ECM is suitable for the treatment of a wound, including the specific skin ulcers as claimed.
Applicant’s arguments have been fully considered, but have not been found persuasive.
With regard to Applicant’s argument that the structural and chemical integrity of the ECM of Li is not maintained as claimed; as discussed in the indefiniteness rejection above, as amended, claim 52 recites the limitation “wherein the isolation of the ECM or ECM protein is performed such that the scaffold maintains its structural and chemical integrity”; this limitation is indefinite, because it is unclear what “the scaffold” is intended to refer to. Further, if this limitation is intended to indicate that the ECM maintains its structural/chemical integrity, it is unclear how this is intended to be done when filtration, centrifugation, immune conjugation, or scrapping the ECM proteins is also intended to be performed. For the purposes of examination, performance of filtration, centrifugation, immune conjugation, or scrapping the ECM proteins as claimed is deemed to be performing isolation of the ECM/ECM proteins such that the scaffold maintains its structural and chemical integrity.
As Li et al. teach production of ECM using centrifugation, this limitation is deemed to be met.
With regard to Applicant’s argument that Rahmo does not teach that the SMS cell ECM is suitable for the treatment of a wound, including the specific skin ulcers as claimed; as noted in the rejections above, skin ulcers are not interpreted to be required in the claims as amended. Further, it is noted that Li et al. teach a method of treating a wound by contacting the wound with a composition comprising stem cell extracellular matrix (ECM) (Abs.; Para. 28; claim 29); and Rahmo teaches the treatment of tissue and organ damage in a subject using SMS cell products, wherein SMS cells have an extraordinary ability to form complex multicellular macrostructures, and also heavily excrete ECM, which makes these cells amenable for medical applications (Abs.; Para. 20-21, 29).
It would have been obvious to one of ordinary skill in the art to combine the teachings of Li et al. and Rahmo, because both teach the treatment of tissues using stem cells and their produced components. The use of SMS cells for the production of ECM and treatment of tissues and organs is known in the art as taught by Rahmo. The use of SMS cell ECM as taught by Rahmo, as the stem cell ECM in the method of Li et al., amounts to the simple substitution of one known stem cell ECM for another, and would have been expected to predictably and successfully provide an alternative know stem cell ECM. Further, the use of SMS cells to provide the stem cell ECM would have also been expected to predictably improve the method of Li et al., as it is known from the teachings of Rahmo, that SMS cells have an extraordinary ability to form complex multicellular macrostructures, and also heavily excrete ECM, which makes these cell amenable for medical applications, such as would healing as desired by Li et al.
Conclusion
No claims are allowable.
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 JENNIFER M.H. TICHY whose telephone number is (571)272-3274. The examiner can normally be reached Monday-Thursday, 9:00am-7:00pm ET.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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