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 .
DETAILED ACTION
Claims 14, 18-21, 23, and 39-43 are pending.
Response to Amendment
Applicant amended independent claim 14 and added new limitation “mix” and deleted the names of the enzymes. Applicant added new claims 42-43.
The objection to claim 14 is withdrawn in view of the amendment.
The rejection of claims 14, 23 and 40-41 under 35 U.S.C. 112(a) is withdrawn in view of the amendment.
The rejection of claims 14, 23, and 40-41under 35 U.S.C. 112(b) is withdrawn in view of the amendment.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 11/04/2025 is acknowledged and has been considered.
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 18 and 21 remain rejected and new claim 42 is 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 reducing the amount of malodorous fatty acids in a subject's sweat comprising applying all 32 functional enzymes purified from Staphylococcus, does not reasonably provide enablement for reducing the amount of malodorous fatty acids in a subject's sweat comprising applying any one functional enzyme selected from the group consisting of the recited enzymes. 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 commensurate in scope with these claims.
In making a determination that a disclosure does not satisfy the enablement requirement, the factors that may be considered include: (A) the breadth of the claims, (B) the nature of the invention, (C) the state of the prior art, (D) the level of one of ordinary skill, (E) the level of predictability in the art, (F) the amount of direction provided by the inventor, (G) the existence of working examples, and (H) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. While it is not essential that every factor be examined in detail, those factors deemed most relevant should be considered.
Nature of the invention. The claims are drawn to a method of reducing the amount of malodorous fatty acids in a subject's sweat comprising obtaining by purification a mix of functional enzymes from a bacterial Staphylococcus species and applying the mix of purified functional enzymes topically. Claim 18 limits the mix of functional enzymes to comprises one or more enzymes selected from the group consisting of facyl CoA dehydrogenase FadE, fenoyl CoA hydratase FadB, 3-hydroxyacyl-CoA dehydrogenase FadJ, and β-ketothiolase FadA. Claim 21 limits the mix of functional enzymes to comprises one or more enzymes selected from the group consisting of farnesyl-diphosphate farnesyltransferase, farnesyl diphosphate synthase, diphosphomevalonate decarboxylase, phosphomevalonate kinase, mevalonate kinase, hydroxymethylglutaryl-CoA reductase, hydroxymethylglutaryl-CoA synthase, and acetyl-CoA C-acetyltransferase. Claim 42 limits the mix of functional enzymes to comprises one or more enzymes selected from the group consisting of acyl CoA dehydrogenase FadE, enoyl CoA hydratase FadB, 3-hydroxyacyl-CoA dehydrogenase FadJ, β ketothiolase FadA, acetyl-CoA carboxylase AccA, acetyl-CoA carboxylase AccB, acetyl-CoA carboxylase AccC, acetyl-CoA carboxylase AccD, malonyl-CoA:ACP transacylase FabD, β-ketoacyl-ACP synthases FabH, NADPH-dependent β-ketoacyl-ACP reductase FabG, 3-hydroxyacyl-ACP dehydratase FabZ, β-hydroxydecanoyl-ACP dehydrase FabA, 3-ketoacyl-ACP synthases I FabB, β-ketoacyl-ACP synthase FabF, enoyl-ACP reductase Fabl, enoyl-ACP reductase FabL, enoylACP reductase FabK, acetyl-CoA C-acetyltransferase, hydroxymethylglutaryl-CoA synthase, hydroxymethylglutaryl-CoA lyase, 3-oxoacid CoA-transferase, acetoacetate decarboxylase, 3-hydroxybutyrate dehydrogenase, farnesyl-diphosphate farnesyltransferase, farnesyl diphosphate synthase, diphosphomevalonate decarboxylase, phosphomevalonate kinase, mevalonate kinase, hydroxymethylglutaryl-CoA reductase, hydroxymethylglutaryl-CoA synthase, and acetyl-CoA C-acetyltransferase.
Breadth of the claims. The breadth of the claims is exceedingly large and fails to receive adequate support in the specification. Claims 18, 21, and 42 encompass reducing the amount of malodorous fatty acids in a subject's sweat comprising any of the recited enzymes.
Guidance in the specification and working examples. The specification discloses purifying enzymes from Staphylococcus by precipitation of proteins (enzymes) and crystallization ([0066]). The activity of the enzymes of the bacterial lysates was tested ([0067]), and a spray was prepared containing the live bacteria or the bacterial lysates/purified enzymes and applied topically ([0068]). A spray solution containing lyophilized S. epidermidis bacteria was used on subjects ([0069]), as well as a spray containing the non-viable S. epidermidis bacterial lysates, containing active enzymes and other enzymes, such as lipases, amylases, proteases, cellulases, farnesyl-diphosphate that were purchased ([0078]). The specification further discloses Staphylococcus is correlated with better underarm odors and recites some of its enzymes and their function ([0088]-[0161]). The specification discloses subjects used the lyophilized bacterial spray and reported a significant decrease in odor, and subjects used the bacterial enzyme spray which has bacterial lysates with active enzymatic activity and no viable bacterial cells and reported a decreased body on clothing and elsewhere on the skin when the enzymes were applied. The specification provides limited guidance because it only demonstrates using the entire mix of enzymes including the enzymes recited in claims 18, 21, and 42 and does not disclose a single experiment or working embodiment showing reducing the amount of malodorous fatty acids using a single type of enzyme from the group consisting of FadE (acyl CoA dehydrogenase), FadB (enoyl CoA hydratase), FadJ (3-hydroxyacyl-CoA dehydrogenase), FadA (β -ketothiolase), AccA (acetyl-CoA carboxylase), AccB (acetyl-CoA carboxylase), AccC (acetyl-CoA carboxylase), AccD (acetyl-CoA carboxylase), FabD (malonyl-CoA:ACP transacylase),FabH (β-ketoacyl-ACP synthases), FabG (NADPH-dependent β-ketoacyl-ACP reductase), FabZ (3-hydroxyacyl-ACP dehydratase), FabA (β-hydroxydecanoyl-ACP dehydrase), FabB (3-ketoacyl-ACP synthases I), FabF (β-ketoacyl-ACP synthase (chain elongation)), FabI (enoyl-ACP reductase), FabL (enoyl-ACP reductase), FabK (enoyl- ACP reductase), acetyl-CoA C-acetyltransferase, hydroxymethylglutaryl-CoA synthase,hydroxymethylglutaryl-CoA lyase, 3-oxoacid CoA-transferase, acetoacetate decarboxylase, 3-hydroxybutyrate dehydrogenase, farnesyl-diphosphate farnesyltransferase, farnesyl diphosphate synthase, diphosphomevalonate decarboxylase,phosphomevalonate kinase, mevalonate kinase, hydroxymethylglutaryl-CoA reductase,hydroxymethylglutaryl-CoA synthase, and acetyl-CoA C-acetyltransferase. The examples disclose using bacterial lysates or protein precipitate from the lysate which is understood to contain all the recited enzymes in the recited group as well as other functional proteins from the bacteria.
State of the prior art and Unpredictability. Reference Callewaert (Experimental dermatology 26.5 (2017): 388-391, of record in IDS filed 09/27/2021) reports volatile fatty acids cause malodor (page 399 para. 1) and reports Staphylococcus epidermidis which correlated with a better underarm odor can be applied as living bacteria or as lysate (page 390 left column para. 2). Reference Barzantany (International journal of cosmetic science 34.1 (2012): 2-11) reports the partial degradation of long-chain fatty acids (LCFAs) into volatile short-chain fatty acids causes malodor and reports bacterial enzymes potentially contributing to human body odor formation and involved in the fatty acid metabolism include FadD, FadE, enoyl CoA hydratase, FadB, FadA, and FadH (page 5 “Biotransformation of long-chain fatty acids (LCFAs)” and Figure 3).
Amount of experimentation necessary. The above-mentioned details establish that one skilled in the art would not be able to make or use the full scope of claimed invention with a reasonable expectation of success and without undue experimentation.
Taking these factors into account, undue experimentation would be required by one of ordinary skill in the art to practice the full scope of the claimed invention. Thus, the claims are not fully enabled by the disclosure.
Applicant may consider amending claims 18, 21, and 42 to delete “one or more enzymes selected from the group consisting of” in order to obviate the rejection.
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 18 and 21 remain rejected and new claim 42 is 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.
Claims 18, 21, and 42 recite “mix of functional enzymes comprises one or more enzymes”. The claim is indefinite because a mix requires at least two components, thus the mix of enzymes cannot comprise only one enzyme.
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.
Claims 14, 18, 21, 23 and 39-41 remain rejected and new claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Callewaert (Experimental dermatology 26.5 (2017): 388-391, hereinafter “Callewaert”, of record in IDS filed 09/27/2021) in view of Toala (Trends in food science & technology 75 (2018): 105-114).
Regarding claims 14, 18, 21, and 42, the limitation “functional enzyme” is interpreted as “active enzyme”. Callewaert teaches volatile fatty acids cause malodor (page 399 para. 1) and teaches a method of direct application of probiotics/non-odor-causing bacteria to treat malodor (Abstract). Callewaert teaches Staphylococcus epidermidis correlated with a better underarm odor (page 390 left column para. 1). Callewaert teaches the bacteria can be applied as living bacteria or as lysate (page 390 left column para. 2). Applicant discloses the functional enzymes recited in claims 18, 21 and 42 are inherently found in Staphylococcus epidermidis (Specification [0016], pages 19-23). Callewaert’s enzyme mix in the Staphylococcus epidermidis lysate inherently comprises the instantly recited functional enzymes.
Callewaert does not specify the lysate is purified.
However, Toala teaches postbiotics, which are soluble factors secreted by live bacteria or released after bacterial lysis such as enzymes, can be purified (Abstract, page 108 para. Methods used to obtain and identify postbiotics). Advantageously, postbiotics are supposed to be more stable than the living bacteria with favorable safety profile, as there is no need for the uptake of billions of living microbes (page 110 right column last para.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Callewaert by purifying the postbiotics of Staphylococcus epidermidis such as the enzymes as suggested by Toala. One of ordinary skill in the art would be motivated to do so in order to control the application of the composition without the need for living microbes. Since Callewaert suggests the application of Staphylococcus epidermidis, the enzymes contained in the organism and/or lysate would necessarily be present in the application when the method of Callewaert is employed. Since Callewaert and Toala teach a desire to apply bacterial lysates for their physiological benefits, there is a reasonable expectation of success.
Regarding claim 23, Callewaert teaches the sweat is present on skin (Figures 1 and 2).
Regarding claims 39 and 41, Toala teaches usage of probiotics extracts for developing personal care products including deodorants and antiperspirants.
Regarding claim 40, the limitation of “wherein the functional enzymes reduce body odor of the subject” does not limit the method. Whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. See MPEP 2111.04
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Callewaert and Toala as applied to claim 14 above, and further in view of Duong-Ly (Methods Enzymol. 2014; 541 :85-94), Jakoby (Methods in enzymology. Vol. 22. Academic Press, 1971. 248-252), and Zhang (Structural Biology and Crystallization Communications 69.7 (2013): 821-826).
Regarding claim 43, Toalo teaches sonication as cell disruption technique and centrifugation as extraction and clean-up step (page 108 left column last para.).
Callewaert and Toala do not teach bringing the functional enzymes into solution, and purification and precipitation of the functional enzymes using ammonium sulfate and crystallization by changing the pH.
However, Duong-Ly teaches lysing the cells, harvesting the cell lysate through centrifugation, separating the pellet (para. 4.1), adding ammonium sulfate (NH4)2SO4 and precipitating the proteins (Figure 7.2).
Jakoby teaches crystallizing an enzyme in order to purify it (page 248 last para.) and teaches that, following ammonium sulfate extraction, the enzymes are crystallized (page 249 first para.)
Zhang teaches a method to enhance protein crystallization by diverging the pH from the pI of the protein (title, Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method taught by Callewaert by sonicating the cells, separating the pellet from the lysate by centrifugation, precipitating the protein using ammonium sulfate extraction and crystallization by changing the pH, as suggested by Toala, Duong-Ly, Jakoby, and Zhang. One of ordinary skill in the art would be motivated to do so in order to purify the postbiotics including enzymes from Staphylococcus epidermidis.
Response to Arguments
Applicant's arguments filed 11/04/2025 have been fully considered but they are not persuasive.
Applicant argues that by reciting mix of enzymes purified from Staphylococcus, the use of individual enzymes is not encompassed and argues the 35 U.S.C. 112(a) rejections of claims 14, 18, 21, 23, and 39-41.
In response to the argument, claims 18, 21, and 42 recite mix of functional enzymes comprising one enzyme. The use of individual enzyme is encompassed in these claims.
Applicant argues Callewaert teaches away from applying a purified mix of functional bacterial enzymes because the only reference that Callewaert makes to "enzymes" is the sentence bridging pages 389 and 390, which advocates reducing the enzyme load present on skin.
In response to the argument, Callewaert teaches Staphylococcus epidermidis correlated with a better underarm odour and teaches non(or good-)-odourous living bacteria or lysate can be applied as treatment (page 390 left column para. 1-2, Figure 2). Applicant discloses the enzymes recited in claims 18, 21 and 42 are found in Staphylococcus epidermidis (Specification [0016], pages 19-23). Thus, Callewaert’s teaching of applying non(or good-)-odourous living bacteria or lysate such as Staphylococcus epidermidis comprises mix of enzymes.
Applicant argues Callewaert does not teach administration of a purified mix of functional enzymes from a bacterial Staphylococcus species and argues Callewaert provides a clear motivation to use intact Staphylococcus. Applicant argues Callewaert does not provide any teaching or suggestion that Staphylococcus enzymes alone are responsible for less odour formation.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). See MPEP 2145 IV. The rational for the obviousness relies on the combination of Callewaert and Toala. Callewaert teaches Staphylococcus epidermidis correlated with a better underarm odour and teaches reversing the malodour formation using bacterial treatment (page 390 left column para. 1, Figure 2). Callewaert teaches the topical or oral application of living bacteria (or as lysate) can form a valuable and durable alternative for the existing treatments (page 390 left column para.2). Toala is relied upon for teachings the purification of postbiotics which include enzymes. Claim 14 recites the method comprising obtaining by purification a mix of functional enzymes. The claim does not limit the method to Staphylococcus enzymes alone. The claim does not exclude the presence of lysate or whole bacteria of Staphylococcus.
Applicant argues that Callewaert teaches inhibition of malodour-causing species to control body odor and that the term "postbiotics" as taught by Toala does not encompass purified enzymes.
In response to the argument, the claim does not limit the method to Staphylococcus enzymes alone. The method does not exclude the presence of lysate or whole bacteria of Staphylococcus. Toala teaches postbiotics released after bacterial lysis comprise enzymes and offer physiological benefits to the host (Abstract). New reference Duong-Ly teaches enzymes from bacterial lysate can be purified. One of ordinary skill in the art would have a reasonable expectation of success in combining the teachings of Callewaert, Toala and Duong-Ly by applying Staphylococcus lysate and/or purified enzymes on the skin.
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 MARY A CRUM whose telephone number is (571)272-1661. The examiner can normally be reached M-F 8:00-5:00 CT with alternate Fridays off.
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/MARY A CRUM/ Examiner, Art Unit 1657
/THANE UNDERDAHL/ Primary Examiner, Art Unit 1699