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 .
Status of the Claims
Claims 1-11 are currently pending.
Claims 1-11 have been considered on the merits.
Specification
The use of the term StrataGraft™ on pg. 10-12, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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.
Claim 8 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 8 contains the phrase “clinically safe to a patient in need thereof” which is indefinite. It is unclear what limitation the phrase “clinically safe” imparts on the claims. The concept of a composition being “clinically safe” is relative to the standards of the country in which the composition would be applied clinically. Additionally, the specification provides a definition of “clinically safe” to mean “refer[ing] to a level of safety regarding use of a medical device/composition in which the potential benefits of using the device/composition outweigh the risks of using the device/composition” ([0026]). This definition is relative and does not remedy the indefiniteness of “clinically safe”. Appropriate clarification is required. Claim 9 is included in this rejection for being dependent on claim 8.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 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.
Claims 1-11 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Koepsel et al (US20200128815A1), as evidenced by FDA (FDA product entry for: StrataGraft, 2024).
Claim Interpretation: Claim 6 requires that the method further comprises cutting or trimming the allogeneic cultured keratinocyte composition. Claim 5 requires the allogeneic cultured keratinocyte composition be meshed. Meshing is a form of cutting in a specific pattern, therefore claim 6 is being interpreted to be met if the method contains a step of meshing, cutting or trimming.
Regarding claim 1, Koepsel teaches a method of priming allogeneic cultured keratinocytes (termed skin equivalent by Koepsel, [0032]) comprising removing the allogenic cultured keratinocyte composition from sterile packaging ([0049]/[0051]/[0053]), and contacting the allogeneic cultured keratinocyte composition with a hold solution comprising a source of nutrients and osmotic regulators, which can be HEPES and/or F-12 ([0051]) as required by claims 1-3. Koepsel teaches that the allogeneic cultured keratinocyte composition is thawed as required by claim 4 ([0051]). Koepsel teaches that the skin can be meshed as required by claims 5 and 6 ([0057]). Koespel teaches that the method further comprises warming the hold solution to 35-39°C as required by claim 10 (see table between [0069]-[0070] and [0072]). Koepsel also teaches wherein the step of contacting is at least 15 min as required by claim 11 ([0072]).
Koepsel meets the limitations of claim 7, because Koepsel teaches the use of StrataGraft™ as the allogeneic cultured keratinocyte composition ([0057] and Example 1). Koepsel meets the limitation “wherein the allogeneic cultured keratinocyte composition comprises an allogeneic cellularized scaffold, wherein the scaffold further comprises dermal fibroblasts and murine collagen” as evidenced by FDA. FDA teaches that the composition defined by the tradename StrataGraft™ has the proper name of “Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat” (pg. 1, “Proper Name”). Therefore, Koepsel as evidenced by FDA meets the limitation of claim 7.
Claim 8 contains the phrase “clinically safe”, which has been rejected above for being indefinite. The method of Koepsel is being interpreted to be “clinically safe” because the methods of Koepsel further comprise applying the composition to a burn or a wound on a patient in need thereof which meets the limitations of claim 8 ([0010]). Additionally, the Federal Circuit has recently held that a limitation such as “clinically proven effective” does not impart patentability where it lacks a functional relationship with the claimed method (See Bayer Pharma AG v. Mylan Pharm. Inc., Fed. Cir. Sept. 23, 2025).
Claim 9 contains the phrase “wherein the hold solution and the allogeneic cultured keratinocyte composition produce no immunological responses or adverse events to a patient in need of thermal burn treatment”. The method of Koepsel is being interpreted to “produce no immunological responses or adverse events” because the methods of Koepsel further comprise applying the composition to a burn or a wound on a patient in need thereof which meets the limitations of claim 9 ([0010]).
Claims 8-9 contain a wherein clause that recites the intended result of the method rather than requiring an additional step be performed. Claim 8 recites “wherein the hold solution and the allogeneic cultured keratinocyte composition are clinically safe to a patient in need thereof”. Claim 9 recites “wherein the hold solution and the allogeneic cultured keratinocyte composition produce no immunological responses or adverse events to a patient in need of thermal burn treatment”. MPEP 2111.04 states “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed” and that a such a clause ‘"in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Therefore since these claims only recite the results of the steps, then art reading on claim 1 will also read on these results since performing the same steps will inherently lead to the same results in the absence of evidence to the contrary including unexpected results.
Therefore, the claims are anticipated by Koepsel as evidenced by FDA.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONSTANTINA E STAVROU whose telephone number is (571)272-9899. The examiner can normally be reached M-F 8:00-5:00.
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CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/DAVID A MONTANARI/Examiner, Art Unit 1632