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 .
Election/Restrictions
Applicant’s election of Group III in the reply filed on 09/22/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-4, 6, 27, 32-33, 39-40, 42-44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 09/22/2025.
Claims 8, 10, 12, 14, 18-19 are being examined on the merits.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 8, 10, 12, 14, 18-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claims recite a hydrogel composition comprising of collagen, dermatan sulphate, agarose, hyaluronic acid, sphingolipids, keratin, epidermal keratinocytes, mesenchymal stem cells and dermal fibroblasts. The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since the claim is directed to a composition comprising components found within humans the claims are a composition of matter. Step 2A prong one of the analyses evaluates whether the claim is a judicial exception (see MPEP 2106.04). Because the claim states the nature-based products collagen, dermatan sulphate, agarose, hyaluronic acid, sphingolipids, keratin, epidermal keratinocytes, mesenchymal stem cells and dermal fibroblasts, the markedly different characteristics is performed by comparing the nature-based product limitation to its natural counterpart.
The claim recites the naturally occurring components found within humans except for the agarose which is naturally existing polysaccharide found in seaweed. In this case the applicant merely claims a combination of the naturally existing judicial exceptions which are the components recited above. Claiming cells no matter the cell type and components secreted from cells such as complex sugar molecules and types of collagens is still claiming those judicial exceptions. The closest naturally occurring counterparts are those same molecules, compounds, cells found already existing in nature and these are chemically identical to those being compared to. All of these are naturally occurring in nature and are not markedly different from its naturally occurring counterpart in its natural state. The properties of the nature-based product as claimed are not markedly different than the properties of these naturally occurring counterparts found in nature as these activities would inherently be found stemming from those components. The components which would give the activities claimed in the instant invention would inherently do the same in nature as there has been nothing done in the instant invention that would make them act in any different way.
Step 2A prong two evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a) identifying whether there are any additional recited elements in the claim beyond the judicial exception and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. This judicial exception is not integrated into a practical application because the applicant is merely claiming the judicial exceptions together without reciting some practical application and the other limitations are only to the amounts of those judicial exceptions. Doing so would be implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b).
The claims do not integrate the judicial exceptions into a practical application because in this context, such integration for a claimed product would be a physical form of the specific practical application instead of a more general composition that is not so limited.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these components and their activity are already found naturally occurring in nature and the addition of an intended use does not impart any added benefit to the compounds or integrate the composition into a practical application.
Step 2 B evaluates whether the claim as a whole, amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (see MPEP § 2106.05(b)).
Since the naturally-occurring components (e.g. agarose) as-claimed are not found together in nature, admixing the ingredients into a single formulation is considered an ‘additional element’ which must be analyzed for eligibility. Admixing naturally-occurring cells and cellular components in a manner similar to what the applicant claims is routine practice in the art as evidence by at least the following documents: US20040170615A1, US20050058629A1, US20040078090A1, US7211648B2, US20080031962A1.
Please also note, the mere modifying the concentration and proportions of the product/composition is not sufficient to remove the claimed composition from a judicial exception.
Therefore, admixing the claimed naturally-occurring ingredients at such a high degree of generality merely involves applying the natural principal and appears to be no more than a drafting effort to claim the judicial exception itself; a mixture of naturally-occurring components that is not markedly different from its’ closest-occurring natural counterpart and which does not offer significantly more than the judicial exception.
Although the applicant provides data showing that the cells and cellular components when combined together can support the growth of new cells to treat skin regeneration, these components (the cells and cellular components being claimed) are already known to do so in nature. Combining agarose which is not found within the human skin to the composition would act in a similar manner as it does in nature as it is a polysaccharide known for forming hydro(gels). Combining collagen, keratin, hyaluronic acids, dermatan sulfate, sphingolipids etc. together with an expectation that they will support the growth of new tissues is expected as these proteins and glycosaminoglycans and sphingolipids do the same in the human skin naturally.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 8, 10, 12, 14, 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Burkhard Mathies (EP2827914B1), Suchitra SumirtWO2017076782A1) and Sonia Borodzicz et. al. (The role of epidermal sphingolipids in dermatological diseases, Lipids in Health and Disease (2016) 15:13).
Mathies teaches compositions which include collagen and hyaluronic acid for use in a method for repair of a ligament or tendon in a subject and teaches the collagen can be type I (see claim 1 and 0038). The composition comprises of three layers which comprises of collagen and being cell porous, a matrix layer comprising of hyaluronic acid and a third layer which is disposed on the matrix layer such that the matrix later is sandwiched between the support and third layer (see claim 1). Mathies teaches wherein the matrix can comprise of dermatan sulfate (see 0087 and 0089) and agarose (see 0168).
Mathies teaches wherein collagen-glycosaminoglycan (CG) copolymers have been used successfully in the regeneration of dermis (see 0084).
Mathies teaches wherein in various embodiments the matrix comprises of hydrogels (see 0065, 0067-0068).
Mathies teaches that “hyaluronic acid, also called hyaluronan or hyaluronate, is a glycosaminoglycan. It is a naturally occurring biopolymer having biological functions from bacteria up to higher animals including humans. In animals, it is one of the chief components of the extracellular matrix. It contributes significantly to cell proliferation and migration”. (see 0069).
Mathies teaches adding MSCs and in the presence of collagen will differentiate into fibroblasts (see 0159) and specifically teaches culturing the composition with fibroblasts (see 0185-0189).
Mathies does not specifically teach wherein the composition contains sphingolipids in the top layer of the hydrogel or teach adding epidermal keratinocytes.
Borodzicz teaches that “Sphingolipids have both structural and biological functions in human epidermis [1, 2]. The barrier between the environment and the human body is maintained by the stratum corneum (SC), the most external layer of the epidermis. The stratum corneum is composed of terminally differentiated keratinocytes and extracellular lipids, such as ceramides (CER), cholesterol and free fatty acids in almost equimolar quantities. The main function of these lipids in the stratum corneum is the formation of the skin barrier and the prevention of transepidermal water loss (TEWL) [1, 3]. Ceramides are among the most important epidermal sphingolipids and compose about 50 % of intercellular stratum corneum lipids by mass [3]” (see page 1 background 1st para.).
“Other than the structural function in the epidermis, sphingolipids also play an important role in epidermal signaling. Ceramides regulate such processes as proliferation, differentiation and apoptosis [31]” (see page 2, 2nd para.).
“In vitro investigation revealed that sphingosylphosphorylcholine added to the cultures of human keratinocytes enhanced their proliferation and promoted wound repair by stimulating migration and/or proliferation of the keratinocytes to the denuded areas of keratinocytes monolayers” (see page 2, 3rd para.).
Borodzicz teaches human dermal fibroblasts being cultivated on the bio-compatible repair patch composition (see 0186) and teach also using MSCs (see 0024, 0133 and 0159).
Regarding claim 14, Borodzicz teaches the matrix layer to be lyophilized (see 0081-0082).
Sumirtan-Holgersson’s general disclosure is to compositions and methods for healing wounds.
Sumirtan-Holgersson teaches of similar components for skin healing. Sumirtan-Holgersson teaches “the higher amounts of collagen in the composition (e.g., an engineered biomaterial (e.g., gel composition)) of the present disclosure may promote more rapid infiltration of host cells to the wound and more prompt wound stabilization” (see 0054). Sumirtan-Holgersson teaches that the biomaterial may contain agarose (see 0049) and the biomaterial of the present disclosure may be in a gel form, sponge form, foam form, patch form, or a semi-liquid/fluid form. The biomaterial may be in gel form (see 0050).
Sumirtan-Holgersson teaches keratinocytes regulate fibroblast behavior through the production of pro- and anti-fibrotic soluble factors, and that the production of those factors is dependent on the hydration state of the keratinocytes (see 0038) and teaches wherein keratin is produced from the keratinocytes migrating to the composition (see figure 4d and 0015). Sumirtan-Holgersson teaches
Therefore it would have been obvious to persons having ordinary skill in the art before the effective fling date to use sphingolipids in a top layer because as discussed by Borodzicz, sphingolipids play important structural and functional roles in skin epidermal signaling and proliferation of keratinocytes which can ultimately promote wound repair. Additionally, it would have been obvious to create a trilaminar hydrogel comprising of two laminar layers comprising of Type I collagen, dermatan sulfate, hyaluronic acid, keratin and agarose as these components are known for being compiled into layers for creating a matrix and to act as copolymers and structural proteins for successfully regenerating the dermis. Mathies teaches creating three layers comprising of matrices and support layers to heal skin and teaches including the same beneficial skin cells and cell components as claimed. Furthermore, Sumirtan-Holgersson teaches how biocompatible compositions with hyaluronic acid and collagen can help to recruit keratinocytes which deposit keratin into the biocompatible matrix composition and keratin is a known fibrous structural component which provides support and protection in skin. Hyaluronic acid is a glycosaminoglycan which is known to support cell proliferation and migration. Agarose is a supportive polysaccharide which helps to form the hydrogel composition because it is known to form a gel when cooled after being dissolved in water. Dermatan sulfate is a glycosaminoglycan (GAG) found in the extracellular matrix, essential for tissue development and function and collagen type I provides structure and strength to connective tissues. Each of these components have a known particular effect in assisting with the development of skin and connective tissues and extracellular matrices. Each would be an optimizable parameter because one would need to optimize each to be within an effective amount that would contribute to wound repair and tissue healing dependent upon which tissue is targeted and so it would have been obvious to optimize the components to be within the instantly claimed range. This would have been an optimization well within the purview of the skilled artisan unless shown some unexpected results from the applicant. Thus combining the active components claimed into compositions which would be three layers for healing skin would have been obvious given the prior art.
Conclusion
Currently no claims are allowed.
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JACOB A BOECKELMAN Examiner, Art Unit 1655
/TERRY A MCKELVEY/ Supervisory Patent Examiner, Art Unit 1655