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 .
Claim Status
Claims 1-20 are pending.
Claims 1-10 were withdrawn from further consideration (see below).
Claims 11-20 are under consideration.
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on 2/19/2026 is acknowledged.
Claim(s) 1-10 were/was withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 2/19/2026.
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 19-20 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 19 recites “the composition further comprises at least one of a biomimetic to C. acnes, a culture of C. acnes, or components thereof”. It is unclear (A) if Applicant intends to recite “the composition further comprises at least one of a biomimetic to C. acnes, a biomimetic to culture of C. acnes, or biomimetic to components thereof” or (B) if Applicant intends to recite “the composition further comprises at least one of a biomimetic to C. acnes, a culture of C. acnes, or components thereof”. In other words, does claim language “a biomimetic to” modify all three of C. acnes, a culture of C. acnes, and components thereof or does claim language “a biomimetic to” modify only “C. acnes”?
Claim 20 is also rejected because it depends from claim 19 and therefore contains same claim limitation.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 19 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 19 recites that the composition further comprises a culture of C. acnes or components thereof. Claim 19 depends from claim 11 and claim 11 already recites that the composition comprises a culture of C. acnes or components thereof. Therefore, claim 19 fails to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 11-20 are 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a “written description” rejection.
“[T]he purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04.
For a claim to a genus, a generic statement that defines a genus of substances by only their functional activity does not provide an adequate written description of the genus. Regents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997). The recitation of a functional property alone, which must be shared by the members of the genus, is merely descriptive of what the members of the genus must be capable of doing, not of the substance and structure of the members. The Federal Circuit has cautioned that, for claims reciting a genus of antibodies with particular functional properties (e.g., binding to antigen, high affinity, neutralization activity, competing with a reference antibody for binding), “[c]laiming antibodies with specific properties, e.g., an antibody that binds to human TNF-α with A2 specificity, can result in a claim that does not meet written description even if the human TNF-α protein is disclosed because antibodies with those properties have not been adequately described." Centocor Ortho Biotech Inc. v. Abbott Labs., 97 USPQ2d 1870, 1875, 1877-78 (Fed. Cir. 2011).
“[A] sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). A “representative number of species” means that those species that are adequately described are representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (“The ’128 and ’485 patents, however, only describe species of structurally similar antibodies that were derived from Joe-9. Although the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the genus.”). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus to provide a "representative number” of species.
The “structural features common to the members of the genus” needed for one of skill in the art to ‘visualize or recognize’ the members of the genus takes into account the state of the art at the time of the invention. For antibodies, the Federal Circuit has found that possession of a mouse antibody heavy and light chain variable regions provides a structural "stepping stone" to the corresponding chimeric antibody, but not to human antibodies. Centocor, 97 USPQ2d at 1875 (“[T]he application only provides amino acid sequence information (a molecular description of the antibody) for a single mouse variable region, i.e., the variable region that the mouse A2 antibody and the chimeric antibody have in common. However, the mouse variable region sequence does not serve as a stepping stone to identifying a human variable region within the scope of the claims.”). A chimeric antibody shares the full heavy and light chain variable regions with the corresponding mouse antibody; that is, the structure shared between a mouse and chimeric antibody would generally be expected to conserve the antigen binding activity.
Even if a selection procedure is disclosed that was, at the time of the invention, sufficient to enable the skilled artisan to identify antibodies with the recited functional properties, the written description provision of 35 U.S.C § 112 is severable from its enablement provision. Ariad, 94 USPQ2d at 1167; Centocor at 1876 (“The fact that a fully-human antibody could be made does not suffice to show that the inventors of the '775 patent possessed such an antibody.”)
Additionally, “An adequate written description must contain enough information about the actual makeup of the claimed products—“a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials,” which may be present in “functional” terminology “when the art has established a correlation between structure and function.” Ariad, 598 F.3d at 1350. But both in this case and in our previous cases, it has been, at the least, hotly disputed that knowledge of the chemical structure of an antigen gives the required kind of structure-identifying information about the corresponding antibodies.” Amgen Inc v. Sanofi 124 USPQ2d 1354, 1361 (Fed. Cir. 2017). “Further, the “newly characterized antigen” test flouts basic legal principles of the written description requirement. Section 112 requires a “written description of the invention.” But this test allows patentees to claim antibodies by describing something that is not the invention, i.e., the antigen. The test thus contradicts the statutory “quid pro quo” of the patent system where “one describes an invention, and, if the law's other requirements are met, one obtains a patent.” Ariad, 598 F.3d at 1345.” Amgen at 1362.
Claim Analysis
Instant claims are drawn to composition for use in at least one of preventing, improving, or treating a skin condition in a subject, the composition comprising: at least one of Cutibacterium acnes (C. acnes), a culture of C. acnes, or components thereof; and a pharmaceutically and/or cosmetically acceptable carrier.
Instant specification disclosed that Cutibacterium acnes was cultivated in RCM broth and RCM broth was centrifuged to prepare conditioned media/conditioned broth for further testing on Normal Human Epidermal Keratinocytes (NHEK) [0058]. Instant specification disclosed effect of pure media and C. acnes-conditioned media on NHEK (Figures 1-2). Instant specification disclosed gene set enrichment analysis for C. acnes-conditioned media at 5%, 10%, and 20% (Figure 4A-4C). Instant specification disclosed fluorescence microscopy image showing the effect of C. acnes-conditioned media at 0.1%, 0.5%, and 1.0% on NHEK total lipids after 6 days of treatment (Figure 6C-6E).
All the experimental data presented by instant application was performed by C. acnes-conditioned media. In contrast, instant claim 11 recites “components thereof” and therefore claim 11 encompasses a composition comprising components thereof and a pharmaceutically acceptable carrier. Component of Cutibacterium acnes encompasses any and all possible metabolites of Cutibacterium acnes. For example, amino acid alanine is present in C. acnes and therefore alanine is one species of “components thereof” recited by instant claim 11. Although instant specification showed effect of C. acnes-conditioned media on NHEK, instant specification did not show that composition comprising any possible metabolite of Cutibacterium acnes has same effect on NHEK as C. acnes-conditioned media. For example, one of ordinary skill in the art would not be able to predict that composition comprising alanine will have same effect on NHEK as C. acnes-conditioned media.
Claim 19 recites “biomimetic to C. acnes”. Instant specification defined biomimetic as follows: “Biomimetics” are substances that (1) are synthesized by artificial means; and (2) mimic natural substances having known biological function [0049]. However, instant specification did not disclose any substance that is synthesized by artificial means; and (2) mimic the function of Cutibacterium acnes. Furthermore, this biomimetic to C. acnes is not well known in the art. One of ordinary skill in the art would not be able to predict what type of substance synthesized by artificial means will have same function as Cutibacterium acnes. Therefore, instant specification does not provide adequate written description for biomimetic to C. acnes recited by instant claim 19-20.
The disclosure therefore does not show that applicant was in possession of the necessary common attributes or features possessed by the members of the claimed genus. Accordingly, the skilled artisan would not recognize that applicants were in possession of the invention as broadly claimed at the time the application was filed.
Claim Rejections - 35 USC § 102
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.
Claim(s) 11-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vergalito et al (WO2021/165434; published 8/26/2021; 8/21/2024 IDS).
Regarding claim 11, 14 and 17, Vergalito teaches “The present invention relates to a selected bacterial strain of Cutibacterium acnes and/or a cell wall therefrom or a postbiotic of the strain and to medical or nutritional uses thereof. The invention also concerns with pharmaceutical or nutritional compositions containing the strain, cell wall or postbiotic therefrom for the prevention or treatment of inflammatory diseases such as dermatitis or psoriasis or infections, especially skin or mucosal fungal or bacterial infections” (abstract). Vergalito teaches “A composition comprising an effective amount of Cutibacterium acnes deposited under deposit Accession No. DSMZ 28251 according to claim 1, or a postbiotic product (corresponds to postbiotic composition of claim 17) thereof according to claim 2 or a fragment of the cell wall thereof according to claim 4 and a physiologically acceptable carrier” (claim 7). It is well known in the art that pharmaceutically acceptable carrier and physiologically acceptable carrier are alternative names. Vergalito teaches “Typically, postbiotics are produced by the metabolic activity or fermentative processes (corresponds to “derived from a liquid fermentation medium” of claim 17) of bacteria such as probiotics”.
Regarding claim 12, Vergalito teaches “The carrier may take a wide variety of forms depending on the form of preparation desired for administration, e.g. oral or parenteral, including intravenous. In preparing the compositions for oral dosage form, any of the usual pharmaceutical media may be employed, such as, for example, water, glycols, oils, alcohols, flavouring agents, preservatives …”.
Regarding claims 13 and 15, Vergalito teaches that the composition is a topical composition (corresponds to “cosmetic composition of instant claim 15”) preferably in the form of cream, foam, ointment, paste, powder, gel, solution, ovum, douche or emulsion (claim 8). Vergalito teaches “In an aspect the invention provided for the cosmetic use of a topical composition as defined in claims 7, 8 especially for the cosmetic treatment or prevention of sensitive skin, red skin, couperose, dry ski, in particular of the face of a human being.”
Regarding claim 16, Vergalito teaches that the skin disease is atopic dermatitis (claim 13).
Regarding claim 18, wherein-clause of claim 18 describes the process of the product-by-process format claim. Applicant is reminded that even though the process of producing the product is limited by and defined by the process, determination of patentability is based on the claimed structure of the product. If a product that is linked in product-by-process format is the same as the product in the prior art, a claim reciting that product-by-process is unpatentable even though the prior art was made by a different process. In re Thorpe, 227 USPQ 964, 966 (FED. CIR. 1985). See also MPEP 2113. In this case, the products disclosed in the prior art are structurally and materially indistinguishable from the claimed product absent a showing otherwise.
Conclusion
No claim is allowed.
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/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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