DETAILED ACTION
Claims 4-8, 18-19, and 22-24 are pending. Of these, claim 24 is withdrawn as directed to a nonelected invention. Therefore, claims 4-8, 18-19, and 22-23 are 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 2/13/26 and 4/16/26 was filed prior to the mailing date of a Final Office Action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, it was considered by the Examiner.
Election by Original Presentation
Applicant originally presented composition claims but has now added method of use claim 24. Claim 24 is patentably distinct from the composition claims, because the supernatant composition of base claim 4 could be used in a materially different use than the method of improving a hair or scalp condition of a subject as recited by claim 24. For example, the supernatant is rich in enzymes and metabolites such that it could be used in a method of harvesting those enzymes and metabolites. Since Applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 24 is withdrawn from consideration as being directed to a non-elected invention. See 37 C.F.R. 1.142(b) and MPEP 821.03.
To reserve a right to petition the Restriction by Original Presentation, Applicant must timely traverse the requirement or lose the right to petition under 37 CFR 1.144. If Applicant adds any additional claims, Applicant must indicate which of these claims are readable upon the elected invention.
Should Applicant traverse on the ground that the inventions are not patentably distinct, Applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the Examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103(a) of the other invention.
Status of the Rejections
The 112(a) enablement and written description rejections are withdrawn in view of the amendment and filing of a declaration regarding the biological deposit.
The 101 rejection is revised in view of the amendment.
The 102 and 103 rejections are withdrawn in view of the amendment, but new 103 rejections are applied and were necessitated by the amendment.
A new claim objection is added in view of the amendment.
Claim Objections
Claim 8 is objected to because of the following informalities: in line 5, “epidermidis” is misspelled. Correction is required.
Notice of Subject Matter Free of the Prior Art
Claim 8 remains free of the prior art as discussed in the previous Office Action.
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 4-8 and 18-19 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 4-8 and 18-19 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.
Base claim 4 is directed to a culture supernatant of Paracoccus denitrificans deposited under deposit number KCCM12994P, from which the P. denitrificans cells have been removed.
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). The culture supernatant will comprise the components of the bacteria that are water soluble and therefore collected in the supernatant. Therefore, the supernatant is a mixture of naturally occurring compounds that are found together in nature in the Paracoccus denitrificans strain.
As a result, 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 4 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 components of the claimed Paracoccus denitrificans culture supernatant would retain its naturally-occurring structure and function.
Therefore, claim 4 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.
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 4 does not include any additional elements beyond the recited culture supernatant of Paracoccus denitrificans strain that would impart any distinct qualities or characteristics to the components. Therefore, claim 4 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, claim 4 merely recites a nature-based product and not any elements that result in an alteration of the natural product. Therefore, claim 4 does 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 4 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 4 is directed toward a judicial exception under 35 USC 101. Dependent claims 5-7 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 a culture supernatant of staphylococcus epidermidis deposited 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, such that a mixture of culture supernatants of these two strains also will comprise components that exist 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.
Response to Applicant’s Arguments
Applicant argues that the claims have been amended to be directed to a culture supernatant which is not naturally occurring, and therefore are not drawn to a nature-based product.
In response, and as discussed in the revised rejection, supra, the culture supernatant will comprise the components of the bacteria that are water soluble and therefore collected in the supernatant. Consequently, the supernatant is a mixture of naturally occurring compounds that are found together in nature in the Paracoccus denitrificans strain, and therefore is still a nature-based product.
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 4-7 and 18-19 are rejected under 35 U.S.C. 103 as unpatentable over Hahnke et al. (Frontiers in Microbiology (January 2014 Volume 5 Article 18).
As to claims 4-7 and 18-19, Hahnke is directed to an improved medium for the anaerobic growth of Paracoccus denitrificans Pd1222 and which comprises nutrients for the strain to grow (Title, Abstract, and pages 2-3), and teaches that the bacteria were cultured in solution and centrifuged to obtain a supernatant in which the P. denitrificans cells have been removed (last full paragraph of page 3 and paragraph bridging pages 3-4). The Hahnke composition reads on claims 18-19 because it is capable of being used as a cosmetic, pharmaceutical, or health functional food. The recitations of claims 18-19 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 Hahnke composition.
As to claims 4-7 and 18-19, Hahnke does not further expressly disclose that the bacteria are the strain deposited under the deposit number KCCM12994P as recited by claim 4, 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),
As to claim 4, the claim language does not in fact require the presence of the strain deposited under the deposit number KCCM12994P because the last clause of the claim expressly states that the P. denitrificans cells have been removed from the culture supernatant. Therefore, the Hahnke supernatant, which is obtained from a Paracoccus denitricans culture solution, is treated as being the same as the claimed composition based upon the evidence of record. 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.
The Hahnke 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.
Claim 23 is rejected under 35 U.S.C. 103 as unpatentable over Hahnke et al. (Frontiers in Microbiology (January 2014 Volume 5 Article 18) as applied to claims 4-7 and 18-19 above, and further in view of Shearer et al. (Journal of Bacteriology, Nov. 1999, p. 6907-6913; of record).
The teachings of Hahnke are relied upon as discussed above, but they do not further expressly disclose that the composition further comprises a yeast extract.
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 claim 23, 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 modify the teachings of Hahnke by growing the Paracoccus denitrificans in a solution comprising L broth, yeast extract, and sodium chloride because Shearer teaches that Paracoccus denitrificans can be grown using such a liquid medium such that the skilled artisan reasonably would have expected that it could be used to grow the Paracoccus denitrificans taught by Hankne. Such a modification is merely the simple substitution of one known element for another according to known methods to yield predictable results, which is prima facie obvious. MPEP 2143.
Claim 23 is rejected under 35 U.S.C. 103 as unpatentable over Hahnke et al. (Frontiers in Microbiology (January 2014 Volume 5 Article 18) as applied to claims 4-7 and 18-19 above, and further in view of Vujanovic et al. (US Pat. Pub. 2015/0230478).
The teachings of Hahnke are relied upon as discussed above, but they do not further expressly disclose that the culture medium is R2A liquid medium.
Vajanovic discloses culturing endophytes including bacteria using Reasoner’s 2A medium (paragraphs 4, 436).
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 culture Paracoccus denitrificans to use Reasoner’s 2A medium because Vajanovic teaches that bacteria can be grown using such a liquid medium such that the skilled artisan reasonably would have expected that it could be used to grow the Paracoccus denitrificans taught by Hankne. Such a modification is merely the simple substitution of one known element for another according to known methods to yield predictable results, which is prima facie obvious. MPEP 2143.
Response to Applicant’s Arguments
Applicant’s arguments will be addressed to the extent they may be relevant to the new grounds of rejection. Applicant argues that claim 4 has been amended to incorporate the subject matter of non-cancelled claim 2, which was not rejected under 35 USC 103.
In response, this argument is not persuasive because while claim 4 has been amended to incorporate a reference to a strain having the deposit number KCCM12994P as formerly recited by claim 2, claim 4 also has been further amended to recite a supernatant wherein the cells of the strain having the deposit number KCCM12994P have been removed from the supernatant. Therefore, claim 4 does not in fact require the presence of a strain having the deposit number KCCM12994P and is therefore prima facie obvious over the prior art as discussed in the new grounds of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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