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 .
1. Claims 1 – 10 are pending.
Election/Restrictions
2. Applicant’s election without traverse of Group I (claims 1 – 9) in the reply filed on 12/02/2025 is acknowledged.
3. Claim 10 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 12/02/2025.
Priority
4. This application claims foreign priority to KR10-2020-0612867 filed 11/27/2020.
5. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
6. The information disclosure statement (IDS) submitted on 08/08/2023 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
7. The drawings are objected to because in Figure 1a, “Gruop” is misspelled
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
8. The use of the term Knockout, KGM, and iBright, 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 Objections
9. Claim 8 is objected to because of the following informalities: in line 6, “(a-Minimal essential Medium)” should read “(a-Minimal Essential Medium)”. Appropriate correction is required.
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.
10. Claim 8 contains the trademark/trade name KnockOut DMEM (GIBCO, USA). Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a basal medium and, accordingly, the identification/description is indefinite.
Claim Interpretation
11. For the purpose of applying prior art, “for establishing or culturing keratinocytes” of claim 1 is interpreted as an intended use of the claimed culture medium additive, which does not further define or limit the claimed composition. Compositions are defined by their physical, structural, and chemical properties, not by an intended use or application. See MPEP 2111.02.
12. For the purpose of applying prior art, “wherein the keratinocytes are keratinocytes derived from human skin” of claim 2 is also directed to the intended use of the claimed culture medium additive and does not further limit the claimed composition.
13. For the purpose of applying prior art, “for proliferation” of claim 6 is interpreted as an intended use of the claimed culture medium additive, which does not further define or limit the claimed composition. Compositions are defined by their physical, structural, and chemical properties, not by an intended use or application. See MPEP 2111.02.
14. For the purpose of applying prior art, “for establishing or culturing keratinocytes” of claim 7 is interpreted as an intended use of the claimed culture medium composition, which does not further define or limit the composition. Compositions are defined by their physical, structural, and chemical properties, not by an intended use or application. See MPEP 2111.02.
15. For the purpose of applying prior art, “wherein the culture medium composition suppresses the extension of population doubling time (PDT) of keratinocytes for at least 5 passages” of claim 9 is also directed to the intended use of the claimed culture medium composition and does not further limit the claimed composition.
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.
16. Claims 1 – 9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to naturally occurring composition comprising calcium, an epidermal growth factor, and albumin without significantly more. The claim(s) recite(s) calcium, an epidermal growth factor, and albumin, which are not shown to differ from that in nature.
The Office published Office's new guidance document entitled 2019 Revised Patent Subject Matter Eligibility Guidance, published January 7, 2019. Applicant is directed to the Federal Register, Volume 4, No. 4, pages 50-57 at page 74621.
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Step 1 of the USPTO' s eligibility analysis entails considering whether the claimed subject matter falls within the four statutory categories of patentable subject matter identified by 35 U.S.C. 101: Process, machine, manufacture, or composition of matter. The claims are directed to a composition of matter (step 1, Yes).
Step 2A of the 2019 Revised Patent Subject Matter Eligibility Guidance is a two-prong inquiry. In Step 2A Prong One, examiners evaluate whether the claim recites a judicial exception. The composition of matter (calcium, an epidermal growth factor, and albumin) is directed to a natural phenomenon (Step 2A, prong 1, Yes). Because the claims recite a nature-based product limitation (calcium, an epidermal growth factor, and albumin), the markedly different characteristics analysis is used to determine if the nature-based product limitation is a product of nature exception. As Applicant’s specification teaches that calcium is a biological factor involved in cell survival, proliferation, and differentiation, and the concentration of calcium increases nearing the upper side of epidermis (page 1, lines 20 – 22; page 2, lines 2 – 5), epidermal growth factor (EGF) is a protein that binds to receptors on the surface of the skin and promotes the growth of new cells (page 2, lines 8 – 10), and albumin is known in the art as a naturally occurring protein that is found in the skin (Rabilloud, Thierry, et. al. Molecular biology reports 13.4 (1988): 213-219 at page 215, right col.; page 218, left col. para. 2 – 4 and right col. para. 2), the claim recites products of nature that are calcium, EGF, and albumin. The markedly different characteristics analysis is performed by comparing the nature-based product limitation in the claim to its naturally occurring counterpart to determine if it has markedly different characteristics from the counterpart. Here, the closest natural counterpart is naturally occurring blood. Buzanovskii (Buzanovskii, V. A. "Determination of calcium in blood." Review Journal of Chemistry 9.1 (2019): 12-70.) teaches blood contains calcium and albumin (page 12, para. 1) and Idania (Idania, G., et al. J Mol Biomark Diagn 8.3 (2017): 1000335.) teaches blood contains EGF (page 1, left col.). When the claimed calcium, an epidermal growth factor, and albumin is compared to this counterpart, the comparison indicates that there are no differences in structure, function or other characteristics. Therefore, the claimed calcium, an epidermal growth factor, and albumin is a product of nature exception and recites a judicial exception.
In Step 2A Prong Two, examiners evaluate whether the claim recites additional elements that integrate the exception into a practical application of that exception. This evaluation is performed by (a) identifying whether there are any additional elements recited 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. Besides the judicial exception, claims 1 and 7 recite an intended use of the claimed composition “for establishing or culturing keratinocytes” and claim 7 recites “a basal medium”. An evaluation of whether this limitation is insignificant extra-solution activity is then performed. Note that because Step 2A Prong Two analysis excludes consideration of whether a limitation is well-understood, routine, conventional activity, this evaluation does not take into account whether or not the limitation is well-known. When so evaluated, this additional element is insignificant extra-solution activity because the intended use or “a basal medium” containing the claimed calcium, an epidermal growth factor, and albumin composition does not limit the claimed composition in such a way that is markedly different in structure or biological function from the natural counterpart. Additionally, Applicant’s specification teaches that the calcium, an epidermal growth factor, and albumin are components for skin cell growth (page 1, lines 20 – 22; page 2, lines 2 – 5; page 2, lines 8 – 10). Therefore, the intended use recitation and “a basal medium” fails to meaningfully limit the claims because it is at best the equivalent of merely adding the words “apply it” to the judicial exception. Accordingly, the intended use recitation and “a basal medium” does not integrate the recited judicial exception into a practical application and the claim is therefore directed to the judicial exception (Step 2A, prong 2, No).
In Step 2B, the eligibility analysis 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 into the claim. As discussed with respect to Step 2A Prong Two, the claim recites an intended use recitation and “a basal medium”, which is at best the equivalent of merely adding the words “apply it” to the judicial exception. Mere instructions to apply an exception cannot provide an inventive concept. At Step 2B, the evaluation of the insignificant extra-solution activity consideration takes into account whether or not the extra-solution activity is well-known. Here, recitation of the claimed calcium, an epidermal growth factor, and albumin with a basal medium is recited at a high level of generality and the combination of the claimed composition and basal media does not change in any way the natural functioning of the claimed composition. Thus, recitation of “in the form of a dressing material” does not amount to significantly more and does not provide an inventive concept (Step 2B: No).
In the instant case, the limitations of the claims do not impose limits on the claim scope such that they are not markedly different in structure from a naturally occurring product.
Markedly different characteristics can be expressed as the product' s structure, function, and/or other properties. In accordance with this analysis, a product that is purified or isolated, for example, will be eligible when there is a resultant change in characteristics sufficient to show a marked difference from the product' s naturally occurring counterpart. If the claim recites a nature-based product limitation that does not exhibit markedly different characteristics, the claim is directed to a ‘‘product of nature” exception (a law of nature or naturally occurring phenomenon), and the claim will require further analysis to determine eligibility based on whether additional elements add significantly more to the exception.
Limitations that were found not to be enough to qualify as ‘‘significantly more” when recited in a claim with a judicial exception include: Adding the words ‘‘apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer; simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry; adding insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea; or generally linking the use of the judicial exception to a particular technological environment or field of use.
In the instant case, the limitations of the claim does not impose limits on the claim scope such that they are not markedly different in structure from a naturally occurring product.
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.
17. Claim(s) 1 – 3 and 6 – 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oku (Oku H, et. al. In Vitro Cell Dev Biol Anim. 1994 Aug;30(8):496-503), hereinafter Oku.
Claim 1 is directed to a culture medium additive for establishing or culturing keratinocytes,
comprising calcium, an epidermal growth factor, and albumin.
Claim 8 is directed to a culture medium composition for establishing or culturing keratinocytes, comprising the culture medium additive of claim 1 and a basal medium.
Regarding claims 1, 2, and 6, Oku teaches a culture medium additive comprising calcium, epidermal growth factor (EGF), and albumin (page 497, right col. para. 5) for culturing keratinocytes for proliferation.
Regarding claim 3, Oku teaches the additive comprises 0.1 mM CaCl2 (page 497, right col. para. 5).
Regarding claim 7 – 9, Oku teaches the calcium, EGF, and albumin are present in a basal media (claim 7 and 9) that is MCDB (claim 8) (page 497, right col. para. 5).
Therefore, Oku anticipates claims 1 – 3 and 6 – 9.
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.
18. Claim(s) 1 – 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oku (Oku H, et. al. In Vitro Cell Dev Biol Anim. 1994 Aug;30(8):496-503), hereinafter Oku in view of Kim (US-20170355952-A1; Filed 11/17/2015; Published 12/14/2017), hereinafter Kim in view of Yu (US-20160102289-A1; Filed 10/13/2015; Published 04/14/2016), hereinafter Yu.
Oku anticipates claims 1 – 3 and 6 – 9 as set forth above. Oku teaches an EGF concentration of 10 ng/mL (page 497, right col. para. 5) but does not teach EGF at a concentration of 0.001 to 1 ng/ml of claim 4. Oku teaches an albumin concentration of 2 mg/mL (page 497, right col. para. 5) but does not teach an albumin concentration of less than 1 mg/mL and more that 0.001 mg/mL of claim 5. However, Oku teaches calcium, EGF, and albumin were essential for the growth of rat keratinocytes and stimulation of rat keratinocyte proliferation at 5 ng/mL EGF that reached saturation at 25 ng/mL EGF (page 497, right col. last para.; page 499, left col.; Figure 2C). Oku teaches culture of keratinocytes is a useful model for the study of lipid metabolism as well as for the investigation of differentiation (page 496, left col. para. 1). Oku teaches it has been suggested that each type of cell has a unique set of quantitative growth requirements that must be satisfied to obtain satisfactory multiplication (page 496, right col. para. 2). Oku teaches the additives were adjusted for the best growth of rat keratinocytes (page 496, right col. para. 3). Oku teaches that one approach to develop a serum-free medium is to begin with a previously developed medium, and then to refine it for the cell type of interest (page 497, right col. para. 6). Oku teaches culture conditions established for human keratinocytes did not support the rapid growth of rat keratinocytes even with supplementation of bovine pituitary extract (page 502, left col. para. 1).
Regarding claims 4 and 5, Kim teaches an additive composition comprising 0.8 ng/mL or 0.4 ng/mL or 0.6 ng/mL of EGF and 100 µg/mL (0.1 mg/mL) of BSA that is added to DMEM/F12 medium in Examples 1 – 3 and 6 – 7 (page 4, 0084 – 0086; page 5, para. 0089 – 0090). Kim teaches 0.8 ng/mL EGF and 10 µg/mL BSA added to DMEM/F12 in Example 4 (page 4, para. 0087). Kim teaches in Figure 1 that Example 1 comprising 0.8 ng/mL of EGF and 100 µg/mL of BSA increased human fibroblast cell proliferation rates (Figure 1). Kim teaches the cell culture medium may be a medium capable of culturing keratinocytes or fibroblasts (page 2, para. 0040). Kim teaches the cells constituting skin cells comprise keratinocytes and fibroblasts (page 1, para. 0003). Kim teaches the composition relates to a cosmetic composition for improving the condition of the skin (page 1, para. 0001). Kim teaches EGF promotes collagen synthesis thereby showing the effect of wrinkle improvement but excessive usage is restricted for safety purposes and therefore a composition capable of maximizing its effect even with a small amount is needed (page 1, para. 0002). Kim teaches there is a continuous need to develop a composition that is safe to a living body and exhibits excellent effects of improving skin conditions, e.g., wrinkle improvement, skin regeneration, and wound healing without containing fetal bovine serum (page 1, para. 0006).
Yu teaches EGF at 0.5 ng/mL and calcium at 80 µM for supplementing MCDB media for the expansion and maintenance of primary human keratinocytes in Example 2 (page 16, para. 0158; Table 7). Yu teaches KCM4 media containing EGF at 0.5 ng/mL and calcium at 80 µM performed similarly to commercially available chemically defined media (page 17 – 18, para. 0165). Yu teaches the medium may contain alternatives to serum where albumin is an alternative to serum (page 8, para. 0104). Yu teaches primary human keratinocytes are used to generate epithelial sheets to apply to damaged skin epithelium and corneal epithelium and are in demand for cosmetic testing and drug development (page 3, para. 0037). Yu teaches the responses of donor-derived keratinocytes to individual compounds provide invaluable insights to how a donor would react under both physiological and pathological conditions, thus opening the gate to personalized cosmetics and skin treatments (page 3, para. 0037).
It would have been obvious prior to the effective filing date of the invention as claimed for the person of ordinary skill in the art to combine the teachings of Oku regarding a composition comprising calcium, epidermal growth factor, and albumin for culturing rat keratinocytes with the teachings of Kim regarding a composition comprising 0.8 ng/mL of EGF and 100 µg/mL of BSA and media for culturing human fibroblasts and keratinocytes with the teachings of Yu regarding a composition comprising 0.5 ng/mL and calcium at 80 µM for supplementing MCDB media that may contain albumin for the expansion and maintenance of primary human keratinocytes to arrive at the claimed composition wherein the epidermal growth factor is contained at a concentration of 0.001 to 1 ng/ml and wherein
the albumin is contained at a concentration of 0.001 mg/ml or more and less than 1 mg/ml. One would have been motivated to combine the teachings of Oku, Kim, and Yu in a composition for culturing human keratinocytes for cosmetic purposes, drug development, and wound healing as Oku teaches the culture of keratinocytes is a useful model for the study of lipid metabolism, Kim teaches there is a continuous need to develop a composition that is safe to a living body and exhibits excellent effects of improving skin conditions, e.g., wrinkle improvement, skin regeneration, and wound healing without containing fetal bovine serum, and Yu teaches the responses of donor-derived keratinocytes to individual compounds provide invaluable insights to how a donor would react under both physiological and pathological conditions, thus opening the gate to personalized cosmetics and skin treatments. One would have a reasonable expectation of success in combining the teachings as Oku teaches calcium, EGF, and albumin were essential for the growth of rat keratinocytes but culture conditions established for human keratinocytes did not support he rapid growth of rat keratinocytes suggesting each type of cell has a unique set of quantitative growth requirements that must be satisfied to obtain satisfactory multiplication, Kim teaches 0.8 ng/mL of EGF and 100 µg/mL of BSA in a medium increased human fibroblast cell proliferation rates and the medium may be used for culturing keratinocytes, and Yu teaches KCM4 media containing EGF at 0.5 ng/mL and calcium at 80 µM performed similarly to commercially available chemically defined media and may contain albumin for culturing keratinocytes.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZANNA M BEHARRY whose telephone number is (571)270-0411. The examiner can normally be reached Monday - Friday 8:45 am - 5:45 pm.
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/Z.M.B./Examiner, Art Unit 1632
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632