DETAILED ACTION
Claims 1-2, 4-11, and 18-21 are pending and under consideration on the merits.
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/5/2024 was filed prior to the mailing date of a first Action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, it was considered by the Examiner. Three references were not considered, however, because they are not in English and no translation or concise statement of relevance was provided.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Notice of Subject Matter Free of the Prior Art
Claims 2, 8, and 10 are free of the prior art.
Claim 2 recites a Paracoccus denitrificans strain deposited under the deposit number KCCM12994P and which comprises 16S rRNA comprising a sequence having 95% or more sequence identity with SEQ ID NO: 1 as required by base claim 1. The prior art discloses a Paracoccus denitrificans strain that comprises 16S rRNA comprising a sequence having 95% or more sequence identity with SEQ ID NO: 1 (see 102 rejection, infra). The prior art does not disclose or suggest, however the Paracoccus denitrificans strain that is the biological deposit KCCM12994P.
Regarding claims 8 and 10, KR20210025317A (of record in IDS) discloses Staphylococcus epidermis deposit KCCM12559P (see paragraph 1). The inventive entity of KR20210025317A is a subset of the inventive entity of the present application, and the publication date of KR20210025317A of 3/09/21 is within the one year grace period prior to the foreign priority date of 9/14/21 of the present application. Applicant, however, has not perfected the foreign priority claim by filing an English translation of the foreign priority document. Therefore, the present application is currently assigned a filing date of 9/6/22, which is the PCT filing date. Therefore, KR20210025317A is currently treated as prior art to the present application. Nevertheless, the prior art including KR20210025317A nowhere teaches or suggests a composition comprising Staphylococcus epidermis deposit KCCM12559P in combination with a Paracoccus denitrificans strain, lysate, culture solution, or extract thereof as required by claims 8 and 10. Therefore, claims 8 and 10 are free of the prior art.
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 1-2, 4-11, and 18-21 are rejected under 35 U.S.C. 101 as being drawn to a nature-based product that is not patentable under 35 U.S.C. 101.
Claims 1-2, 4-11, and 18-21 are drawn to products, which are one of the four categories of statutory subject matter. Therefore, whether the claims lack utility is determined by whether the claims are directed to a judicial exception, and, if so, whether the claims include additional elements that are sufficient to amount to significantly more than the judicial exception, using the Step 2A Prong One, Step 2A Prong Two, and Step 2B analysis. See MPEP 2106.
Step 2A Prong One: Does the claim recite an abstract idea, law of nature or natural phenomenon?
This part of the eligibility analysis evaluates whether the claim recites a judicial exception. As explained in MPEP 2106.04(II), a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim.
Claim 1 is directed to a Paracoccus denitrificans strain which comprises 16S rRNA comprising a sequence having 95% or more sequence identity with SEQ ID NO: 1.
The Paracoccus denitrificans strain has a natural origin based upon the evidence of record. The present specification teaches that the composition of claim 1 is a natural product recovered in its natural form from nature (see, e.g., Example 1 which discloses that the Paracoccus denitrificans strain was obtained by sampling the scalp of a human subject followed by inoculation into a medium and culturing in an incubator).
Therefore, the claim is ‘directed to’ a nature-based product. Since the claims recite a nature-based product limitation, the markedly different characteristics analysis is used to determine if the nature-based product limitation is a product of nature exception. MPEP 2106.04(c)(I). 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. MPEP 2106.04(c)(II). Here, the closest natural counterpart is naturally occurring Paracoccus denitrificans. Claim 1 recites no other elements that would change the structure, function or other characteristics of the individual components in any way. Rather, it is expected that the claimed Paracoccus denitrificans would retain its naturally-occurring structure and function.
Therefore, claim 1 recites a product of nature exception. Association for Molecular Pathology v. Myriad Genetics Inc., 569 U.S. 576, 589-90 (2013) (naturally occurring things are “products of nature” which cannot be patented). Accordingly, the claim recites a judicial exception, and the analysis must proceed to Step 2A Prong Two.
Base claim 9 recites a composition for improving a hair or scalp condition comprising a Paracoccus denitrificans strain, a lysate or a culture solution thereof, or an extract of the culture solution. As noted above, Paracoccus denitrificans has a natural origin. The present specification teaches that the composition administered by claim 2 is a natural product produced by Euglena and recovered in its natural form using a natural fermentation process (see, e.g., paragraphs 4, 27, 92-93, 98, 117). Thus, claim 9 is drawn to naturally occurring components.
The present specification teaches that the composition of claim 1 is a natural product recovered in its natural form from nature (see, e.g., Example 1 which discloses that the Paracoccus denitrificans strain was obtained by sampling the scalp of a human subject followed by inoculation into a medium and culturing in an incubator).
Therefore, the claim is ‘directed to’ a nature-based product. Since the claims recite a nature-based product limitation, the markedly different characteristics analysis is used to determine if the nature-based product limitation is a product of nature exception. MPEP 2106.04(c)(I). 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. MPEP 2106.04(c)(II). Here, the closest natural counterpart is naturally occurring Paracoccus denitrificans. Claim 1 recites no other elements that would change the structure, function or other characteristics of the individual components in any way. Rather, it is expected that claimed Paracoccus denitrificans would retain its naturally-occurring structure and function.
Therefore, claim 1 recites a product of nature exception. Association for Molecular Pathology v. Myriad Genetics Inc., 569 U.S. 576, 589-90 (2013) (naturally occurring things are “products of nature” which cannot be patented). Accordingly, the claim recites a judicial exception, and the analysis proceeds to Step 2A Prong Two.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d)II.
Claim 1 does not include any additional elements beyond the recited Paracoccus denitrificans strain that would impart any distinct qualities or characteristics to the components. Therefore, claim 1 does not recite any elements that would integrate the product of nature exception into a practical application and the claim is therefore directed to the judicial exception.
Claim 9 does not include any additional elements beyond the recited Paracoccus denitrificans strain that would impart any distinct qualities or characteristics to the components. The claim preamble of “improving a hair or scalp condition” merely indicates the intended use of the product and does not provide any further limit on the structure of the product. Therefore, claim 9 does not recite any elements that would integrate the product of nature exception into a practical application and the claim is therefore directed to the judicial exception.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
This part of 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 to the claim. MPEP 2106.05. As discussed with respect to Step 2A Prong Two, claims 1 and 9 merely recite a natural product and not any elements that result in an alteration of the natural product. Therefore, claims 1 and 9 do not include any additional element which would amount to ‘significantly more’ than the judicial exception itself such that the claims as a whole do not amount to significantly more than the judicial exception.
Conclusion: Claim 1 which is directed toward a naturally occurring product, is not markedly different in structure or function as compared to the closest naturally-occurring counterpart. As a result, claim 1 is directed toward a judicial exception under 35 USC 101. Dependent claims 2, 4-7, and 18-19 do not recite the presence of any additional structural elements that would be considered to provide ‘significantly more’ than the judicial exception.’ Dependent claim 8 recites that the composition further comprises staphylococcus epidermidis depositing under the deposit number KCCM112559P. The specification discloses at paragraph 86 as published that this bacterial strain was obtained in the same manner as the Paracoccus denitrificans, i.e., by sampling the scalp of the human subject followed by inoculation into a medium and culturing in an incubator, such that it also has a natural origin. Therefore, the evidence of record indicates that a mixture of Paracoccus denitrificans and staphylococcus epidermidis exists in nature on the human scalp. Therefore, claim 8 also does not include any structural element that would provide significantly more than the judicial exception, because it is drawn to a mixture that exists in nature.
Claim 9, which is directed toward a naturally occurring product, is not markedly different in structure or function as compared to the closest naturally-occurring counterpart. As a result, claim 9 is directed toward a judicial exception under 35 USC 101. Dependent claims 20-21 do not recite the presence of any additional structural elements that would be considered to provide ‘significantly more’ than the judicial exception.’ Dependent claim 10 recites that the composition further comprises staphylococcus epidermidis depositing under the deposit number KCCM112559P. The specification discloses at paragraph 86 as published that this bacterial strain was obtained in the same manner as the Paracoccus denitrificans, i.e., by sampling the scalp of the human subject followed by inoculation into a medium and culturing in an incubator, such that it also has a natural origin. Therefore, the evidence of record indicates that a mixture of Paracoccus denitrificans and staphylococcus epidermidis exists in nature on the human scalp. Therefore, claim 10 also does not include any structural element that would provide significantly more than the judicial exception, because it is drawn to a mixture that exists in nature.
Claim Rejections - 35 USC § 112, first paragraph
The following is a quotation of the first paragraph of 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 1-2, 4-11, and 18-21 are rejected under 35 U.S.C. § 112, first paragraph, because the specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention, because the specification does not provide evidence that the claimed biological materials are (1) known and readily available to the public; (2) reproducible from the written description.
It is unclear if Paracoccus denitrificans as recited by claim 9 and which comprises 16S rRNA having 95% or more sequence identify with SEQ ID NO: 1 as recited by claim 1, and which is deposited under the deposit number KCCM12994P as recited by claim 2, or Staphylococcus epidermidis deposited under the deposit number KCCM12559P as recited by claims 8 and 10, can be reproducibly isolated without undue experimentation. Therefore, a suitable deposit for patent purposes is suggested. Without a publicly available deposit of the above bacteria, one of ordinary skill in the art could not be assured of the ability to practice the invention as claimed. Exact replication of the claimed bacterial strains as claimed is an unpredictable event.
Further, it is unclear that one of skill in the art could produce a composition comprising these strains that would improve hair or scalp condition or proliferate human follicular dermal papilla cells or increase expression of VEGF or FGF7 as recited by claims 5-7 and 9. Undue experimentation would be required to screen all of the possible bacterial species to obtain the claimed product having the functionality recited by these claims.
Because one of ordinary skill in the art could not be assured of the ability to practice the invention as claimed in the absence of the availability of the claimed Paracoccus denitrificans (KCCM12994P) and Staphylococcus epidermidis (KCCM12559P), a suitable deposit is required for patent purposes, and evidence of public availability of the claimed strains or evidence of the reproducibility without undue experimentation of the claimed strains is required.
Applicant's referral to the deposit of Paracoccus denitrificans and Staphylococcus epidermidis at paragraphs 20 and 51 of the specification as published is by itself not sufficient assurance that the required deposit has been made and all the conditions of 37 CFR 1.801-1.809 met. The Office notes that the file history contains a document submitted 2/5/2024 acknowledging receipt of a biological deposit under the Budapest treaty. If the deposit is made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of deposit over his or her signature and registration number stating that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty and that all restrictions upon public access to the deposited material will be irrevocably removed upon the grant of a patent on this application would address the deficiencies discussed above. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State.
If the deposit is not made under the provisions of the Budapest Treaty, then in order to certify that the deposit complies with the criteria set forth in 37 CFR 1.801-1.809 regarding availability and permanency of deposits, assurance of compliance is required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring:
(a) during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request:
(b) all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application:
(c) the deposits will be maintained in a public depository for a period of at least thirty years from the date of deposit or for the enforceable life of the patent of or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest; and
(d) the deposits will be replaced if they should become nonviable or non-replicable.
As an additional means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
If a deposit is made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the biological material described in the specification as filed is the same as that deposited in the depository, stating that the deposited material is identical to the biological material described in the specification and was in the applicant's possession at the time the application was filed. See MPEP 2406 and 37 CFR 1.804(b).
Applicant's attention is directed to In re Lundak, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR 1.801-1.809 for further information concerning deposit practice.
Claims 5-7, 9-11, and 20-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for compositions comprising the recited bacterial strain or lysate or culture solution thereof for improving a hair or scalp condition or that proliferates human follicular dermal papilla cells or increases expression of VEGF or FGF7, does not reasonably provide enablement for compositions comprising an extract of the culture solution that improves a hair or scalp condition or that proliferates human follicular dermal papilla cells or increases expression of VEGF or FGF7. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: 1) scope or breadth of the claims; 2) nature of the invention; 3) relative level of skill possessed by one of ordinary skill in the art; 4) state of, or the amount of knowledge in, the prior art; 5) level or degree of predictability, or a lack thereof, in the art; 6) amount of guidance or direction provided by the inventor; 7) presence or absence of working examples; and 8) quantity of experimentation required to make and use the claimed invention based upon the content of the supporting disclosure. When the above factors are weighed, it is the Examiner’s position that one skilled in the art could not practice the invention without undue experimentation.
While all of the factors have been considered, only those required for a prima facie case are set forth below.
Breadth of the Claims
Claim 4 (from which claims 5-8 depend) and claim 9 (from which claims 10-11 and 20-21 depend) recite a composition comprising a Paracoccus denitrificans strain, a lysate or a culture solution thereof, or an extract of the culture solution. The term “extract” broadly reads on a composition comprising any component of the Paracoccus denitrificans strain, whether alone or in any combination.
Claim 10 recites a composition comprising Staphylococcus epidermidis, a lysate or a culture solution thereof, or an extract of the culture solution. The term “extract” broadly reads on a composition comprising any component of the Staphylococcus epidermidis strain, whether alone or in any combination.
Claim 5 and claim 9 further recite that the composition is for improving a hair or scalp condition, and claim 6 further recites that the improved hair or scalp condition is hair growth promotion, alopecia prevention, and hair root strengthening, and claim 7 recites that the composition proliferates human follicular dermal papilla cells or increases expression of VEGF or FGF7.
Therefore, all of claims 5-7, 9-11, and 20-21 that are subject to this rejection require that the composition has specific biological effects and all of these claims also read on compositions comprising an extract of the recited bacterial strain as opposed to the strain itself.
Guidance Provided by Specification/Working Examples
Examples 1-4 disclose the preparation of inventive compositions comprising culture solutions of Paracoccus denitrificans, Staphylococcus epidermidis, or a combination of culture solutions both Paracoccus denitrificans and Staphylococcus epidermidis. The specification teaches that the inventive compositions all increased the proliferation of dermal papilla cells (Experimental Example 1), and increased the expression of VEGF and FGF7 (Experimental Example 2).
None of the working examples, however, disclose the preparation or testing of inventive compositions comprising an extract of culture solutions of Paracoccus denitrificans, Staphylococcus epidermidis, or a combination of culture solutions of both Paracoccus denitrificans and Staphylococcus epidermidis. Nor does the specification provide any information as to which of the compounds present in Paracoccus denitrificans or Staphylococcus epidermidis are responsible for the ability to provide the functionality recited by claims 5-7, 9-11, and 20-21 and which would provide guidance to the skilled artisan in determining which extracts of Paracoccus denitrificans or Staphylococcus epidermidis would possess said functionality.
Degree of Predictability
The skilled artisan would recognize that there is a correlation between the structure of a compound and its biological activity, but would also recognize that Paracoccus denitrificans and Staphylococcus epidermidis both comprise many thousands of compounds having widely differing structures. Therefore, the skilled artisan could not have predicted that an extract of Paracoccus denitrificans or Staphylococcus epidermidis comprising a selected compound would have the functional properties recited by the claims, merely because it was obtained from a bacterial strain comprising another compound of differing structure which is known to possess the claimed functionality. Therefore, the degree of unpredictability regarding which extracts of Paracoccus denitrificans or Staphylococcus epidermidis would produce the functionality recited by the claims is very high.
Quantity of Experimentation/Conclusion
One of ordinary skill in the art would have to engage in extensive and undue experimentation, conducting a myriad number of experiments to determine which extract comprising which compounds of Paracoccus denitrificans and/or Staphylococcus epidermidis when used by themselves, as opposed to Paracoccus denitrificans and/or Staphylococcus epidermidis in its entirety, would result in the functional properties required by the rejected claims.
In light of the foregoing factors, the evidence as a whole suggests that the specification, in light of the level of knowledge in the art, does not enable one of ordinary skill to make or use the invention as claimed without undue experimentation. Therefore, the claims are prima facie not enabled over their full scope.
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 1 is rejected under 35 U.S.C. 102(a)(1) as anticipated by GenBank Accession No. MK134869 dated 7.31.2019; of record in IDS; hereinafter “GenBank”).
As to claim 1, the entry for GenBank Accession No. MK134869 discloses a Paracoccus denitrificans strain which comprises 16S rRNA comprising a sequence having 100% sequence identity with SEQ ID NO: 1 of claim 1.
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.
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 1, 4-7, 9, and 18-21 are rejected under 35 U.S.C. 103 as unpatentable over GenBank Accession No. MK134869 dated 7.31.2019; of record in IDS; hereinafter “GenBank”).
The teachings of GenBank are relied upon as discussed above, but this reference does not further expressly disclose a composition comprising the Paracoccus denitrificans strain as recited by claim 9, and which is for improving a hair or scalp condition (claims 5 and 9) such as one of the conditions recited by claim 6, wherein the composition
Claims 1, 4-7, 9, 11, and 18-21 are rejected under 35 U.S.C. 103 as unpatentable over GenBank Accession No. MK134869 dated 7.31.2019; of record in IDS; hereinafter “GenBank”) in view of Shearer et al. (Journal of Bacteriology, Nov. 1999, p. 6907-6913).
The teachings of GenBank are relied upon as discussed above, but they do not further expressly disclose a composition comprising the Paracoccus denitrificans strain as recited by claims 4-7 and 9 that is a cosmetic or pharmaceutical (claims 18 and 20) or a health functional food (claims 19 and 21), nor that the composition improves the hair or scalp conditions recited by claim 6 or proliferates human follicular dermal papilla cells or increases expression of VEGF or FGF7 (claim 7), nor that the composition further comprises a yeast extract (claim 11).
Shearer discloses that Paracoccus denitrificans can be grown as part of a composition comprising a medium comprising L broth, yeast extract, and sodium chloride (1st paragraph of Materials and Methods section on page 6907).
As to claims 1, 4-7, 9, 11, and 18-21, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention wishing to produce Paracoccus denitrificans to modify the teachings of Genbank by growing the Paracoccus denitrificans in a solution comprising L broth, yeast extract, and sodium chloride so as to form a composition of the present claims, because Shearer teaches that Paracoccus denitrificans can be grown using such a liquid medium. The resulting composition reads on claims 18-21 because it is capable of being used as a cosmetic, pharmaceutical, or health functional food. The recitations of claims 18-21 that the composition is a “cosmetic,” “pharmaceutical,” or “health functional food” do not place any additional structural limitations on the composition that would exclude the composition of Genbank and Shearer as combined above.
The resulting composition also will be capable of improving a hair or scalp condition (claim 5) such as those recited by claim 6 as well as proliferate human follicular dermal papilla cells or increase expression of VEGF or FGF7 (claim 7) because it comprises the same bacterial strain active ingredient that is recited by the claims and disclosed by the present specification as having these functionalities. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAREN GOTFREDSON whose telephone number is (571)270-3468. The examiner can normally be reached on M-F 9AM-6PM.
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/ Primary Examiner, Art Unit 1600