DETAILED CORRESPONDENCE
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1, 6, 8-11, 17-21, 23, 26, 27, and 31 are pending in the application.
Applicant’s amendment to the claims, filed April 17, 2026, is acknowledged. This listing of the claims replaces all prior versions and listings of the claims.
Applicant’s amendment to the specification, filed April 17, 2026, is acknowledged.
Applicant’s submission of corrected drawings, filed April 17, 2026, is acknowledged.
Applicant’s remarks filed April 17, 2026 in response to the non-final rejection filed February 3, 2026 are acknowledged and have been fully considered.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Restriction/Election
In response to a requirement for restriction/election filed December 29, 2025, applicant elected without traverse the invention of Group I, claims 1, 26, 27, and 31, in the reply filed January 13, 2026.
Claims 6, 8-11, 17-21, and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Drawings
The objection to the drawings is withdrawn in view of applicant’s submission of corrected drawings that precede the view numbers with the abbreviation "FIG." and delete Figure 4.
Claim Objections
The objection to claim 1 is withdrawn in view of applicant’s amendment to claim 1 to recite “isolated polypeptide having lysozyme activity or an enzymatically active fragment thereof.”
Claim Rejections - 35 USC § 112(b)
The rejection of claims 27 and 31 under 35 U.S.C. 112(b) is withdrawn in view of applicant’s amendment to claim 27 to recite “(ii) a surfactant; and (iii) optionally, at least one additional polypeptide…”
Claim Rejections - 35 USC § 112(a)
The rejection of claims 1, 26, 27, and 31 under 35 U.S.C. 112(a) as failing to comply with the written description requirement is withdrawn in view of applicant’s amendment to claim 1 to limit the recited polypeptide to having at least 95% sequence identity with the amino acid sequence of SEQ ID NO: 1.
Claim Rejections - 35 USC § 101
Claims 1, 26, 27, and 31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Applicant’s attention is directed to the "Guidance for Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products”, released on December 16, 2014. This rejection has been modified from its previous version in order to address applicant’s amendment to the claims.
Claim 26
Claim Interpretation: As amended, claim 26 is drawn to a detergent composition comprising a polypeptide having an amino acid sequence having at least 95% sequence identity with the amino acid sequence of SEQ ID NO: 1 and having lysozyme activity.
The specification describes “detergent composition” as a composition intended for use in a wash medium (e.g. a wash liquor) for the cleaning of soiled or dirty objects, including particular textile or non-textile objects or items (paragraph [0087]).
The recitation of “detergent” in the preamble of claim 26 is interpreted as an intended use or purpose of the claimed composition and does not further limit the structure and/or function of the claimed composition.
The only required component of the composition of claim 26 is a polypeptide having an amino acid sequence having at least 95% sequence identity with the amino acid sequence of SEQ ID NO: 1 and having lysozyme activity.
UniProt Database Accession Number A4Z8Q1 (December 11, 2019, 2 pages; cited on Form PTO-892 filed February 3, 2026) discloses a lysozyme from Bubalus bubalis, i.e., water buffalo, with an amino acid sequence that is identical to instant SEQ ID NO: 1 (see Appendix A at pp. 19-20 of the Office action filed February 3, 2026 for sequence alignment).
Given a broadest reasonable interpretation, the polypeptide of the composition of claim 26 encompasses a naturally-occurring lysozyme and the detergent composition of claim 26 encompasses a naturally-occurring composition.
Patent Eligibility Analysis Step 1: The claim is drawn to a composition of matter, which is one of the statutory categories of invention.
Patent Eligibility Analysis Step 2A Prong 1: The claim recites a naturally-occurring composition, which is considered to be a law of nature or a natural phenomenon (a natural product). The composition of claim 26 is not considered to have markedly different characteristics from what occurs in nature, and is considered to be a “product of nature” exception. Accordingly, the composition of claim 26 is directed to a judicial exception.
Patent Eligibility Analysis Step 2A Prong 2: There are no additional elements recited in the claims beyond the judicial exception.
Patent Eligibility Analysis Step 2B: The claim only recites the product of nature, without more and does not include any additional elements that could add significantly more to the judicial exception.
Claims 1, 27, and 31
Claim Interpretation: As amended, claim 1 is drawn to a composition comprising:
a surfactant; and
an isolated polypeptide having lysozyme activity or an enzymatically active fragment thereof, wherein the polypeptide has at least 95% sequence identity with the amino acid sequence of SEQ ID NO: 1.
The required components of the composition of claim 1 are a surfactant and an isolated polypeptide having lysozyme activity or an enzymatically active fragment thereof, wherein the polypeptide has at least 95% sequence identity with the amino acid sequence of SEQ ID NO: 1.
As stated above, UniProt Database Accession Number A4Z8Q1 (supra) discloses a lysozyme from Bubalus bubalis, i.e., water buffalo with an amino acid sequence that is identical to instant SEQ ID NO: 1. Given a broadest reasonable interpretation, the isolated polypeptide recited in claim 1 encompasses a naturally-occurring lysozyme.
Given a broadest reasonable interpretation, the surfactant recited in claim 1 encompasses a naturally-occurring surfactant.
Given a broadest reasonable interpretation, the composition of claim 1 encompasses a combination of a naturally-occurring surfactant and a naturally-occurring lysozyme.
Claims 27 and 31 are drawn to a detergent composition comprising a polypeptide having an amino acid sequence having at least 95% sequence identity with the amino acid sequence of SEQ ID NO: 1 and having lysozyme activity, a polypeptide having protease activity, and a surfactant.
The required components of the detergent composition of claims 27 and 31 are a polypeptide having lysozyme activity or an enzymatically active fragment thereof, wherein the polypeptide has at least 95% sequence identity with the amino acid sequence of SEQ ID NO: 1, a polypeptide having protease activity, and a surfactant.
As stated above, UniProt Database Accession Number A4Z8Q1 (supra) discloses a lysozyme from Bubalus bubalis, i.e., water buffalo with an amino acid sequence that is identical to instant SEQ ID NO: 1. Given a broadest reasonable interpretation, the isolated polypeptide recited in claims 27 and 31 encompasses a naturally-occurring lysozyme.
Given a broadest reasonable interpretation, the polypeptide having protease activity recited in claims 27 and 31 encompasses a naturally-occurring polypeptide having protease activity.
Given a broadest reasonable interpretation, the surfactant recited in claims 27 and 31 encompasses a naturally-occurring surfactant.
Given a broadest reasonable interpretation, the detergent composition of claims 27 and 31 encompasses a naturally-occurring lysozyme, a naturally-occurring polypeptide having protease activity, and a naturally-occurring surfactant.
Patent Eligibility Analysis Step 1: The claims are drawn to a composition of matter, which is one of the statutory categories of invention.
Patent Eligibility Analysis Step 2A Prong 1: The claims recite a composition comprising a combination of naturally occurring components, which is considered to be a law of nature or a natural phenomenon (a natural product). There is no evidence of record of a naturally occurring counterpart to the claimed compositions, so the compositions are compared to the individual components as they occur in nature (see MPEP 2106.04(c).II.A). There is no indication in the specification or evidence of record that the individual components have any characteristics (structural, functional, or otherwise) that are different from the corresponding individual components as each occurs in nature. Furthermore, there is no indication in the specification or evidence of record that combining these components changes the structure, function, or other properties of the naturally occurring components. In other words, the overall combination of components does not render the resulting compositions different from each of the individual components. Thus, the composition of claim 1 and the detergent composition of claims 27 and 31 are not considered to have markedly different characteristics from what occurs in nature, and are considered to be “product of nature” exceptions. Accordingly, the composition of claim 1 and the detergent composition of claims 27 and 31 are each directed to a judicial exception.
Patent Eligibility Analysis Step 2A Prong 2: There are no additional elements recited in the claims beyond the judicial exceptions.
Patent Eligibility Analysis Step 2B: The claims only recite the products of nature, without more and do not include any additional elements that could add significantly more to the judicial exception.
As such, the claims do not qualify as eligible subject matter. For these reasons the claims are rejected under section 101 as being directed to non-statutory subject matter.
RESPONSE TO REMARKS: Regarding claim 1, applicant argues the amendment to claim 1 transforms the claim to a man-made composition that constitutes a practical application to achieve the new and useful end of effective cleaning, and according to applicant, since the claim is not “directed to” a product of nature exception, the analysis should conclude here.
Applicant’s arguments are not found persuasive. There is no dispute that there is no naturally occurring counterpart to the composition of claim 1. However, as noted above, the composition is compared to the individual components as they occur in nature (see MPEP 2106.04(c).II.A) and there is no indication in the specification or evidence of record that the individual components have any characteristics (structural, functional, or otherwise) that are different from the corresponding individual components as each occurs in nature. Moreover, there is no indication in the specification or evidence of record that combining these components changes the structure, function, or other properties of the naturally occurring components. As such, the composition of claim 1 is not considered to have markedly different characteristics from what occurs in nature, and is considered to be a “product of nature” judicial exception, and for the reasons stated above, the composition of claim 1 does not qualify as patent eligible subject matter.
Applicant further argues the combination of lysozyme and surfactant creates a new composition with characteristics distinct from the enzyme in its natural state and amounts to “significantly more” than the judicial exception itself. Applicant cites to Example 4 and Figure 3 of the specification, which, according to applicant, provide evidence of the efficacy of the BbuLys1 lysozyme within various surfactant-based commercial detergents.
Applicant’s arguments are not found persuasive. There is no evidence of record that the commercial detergent solutions in Example 4 are surfactant-based commercial detergent solutions. Even if the commercial detergents disclosed in Example 4 are surfactant-based, the claims are not limited to BbuLys1 lysozyme within the disclosed commercial detergents disclosed in Example 4. Contrary to applicant’s position, there is no indication in the specification or evidence of record that combining the recited generic surfactant and isolated polypeptide changes the structure, function, or other properties of the naturally occurring components.
Regarding claim 26, applicant argues the recitation of “detergent composition” is a man-made formulation containing a surfactant and thus, claim 26 is directed to a practical non-natural application of the recited polypeptide and is patent-eligible subject matter.
Applicant’s arguments are not found persuasive. There is no evidence of record that a “detergent composition” as recited in claim 26 requires a surfactant. Rather, according to the instant specification, “detergent composition” is described as a composition intended for use in a wash medium (e.g. a wash liquor) for the cleaning of soiled or dirty objects, including particular textile or non-textile objects or items (paragraph [0087]). There is no mention of a “surfactant” in the description of “detergent composition” and given a broadest reasonable interpretation in light of the specification, the recitation of “detergent” in the preamble of claim 26 is interpreted as an intended use or purpose of the claimed composition and does not further limit the structure and/or function of the claimed composition. The only required component of the composition of claim 26 is a polypeptide having an amino acid sequence having at least 95% sequence identity with the amino acid sequence of SEQ ID NO: 1 and having lysozyme activity, and for the reasons set forth above, the detergent composition of claim 26 does not qualify as patent eligible subject matter.
Regarding claims 27 and 31, applicant argues the combination of recited components is a man-made detergent composition that constitutes a practical application formulated for the technical purpose of attacking complex soils containing bacteria and protein within a surfactant matrix. Thus, according to applicant, claims 27 and 31 are patent-eligible subject matter.
Applicant’s arguments are not found persuasive. Similar to claim 1 above, it is undisputed that there is no naturally occurring counterpart to the composition of claims 27 and 31. However, as noted above, the composition is compared to the individual components as they occur in nature (see MPEP 2106.04(c).II.A) and there is no indication in the specification or evidence of record that the individual components have any characteristics (structural, functional, or otherwise) that are different from the corresponding individual components as each occurs in nature. Moreover, there is no indication in the specification or evidence of record that combining these components changes the structure, function, or other properties of the naturally occurring components. As such, the detergent composition of claims 27 and 31 is not considered to have markedly different characteristics from what occurs in nature, and is considered to be a “product of nature” judicial exception, and for the reasons stated above, the detergent composition of claims 27 and 31 does not qualify as patent eligible subject matter.
For these reasons the claims are rejected under section 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
The rejection of claim 1 under 35 U.S.C. 103 as being unpatentable over UniProt Database Accession Number A4Z8Q1 (December 11, 2019, 2 pages; cited on Form PTO-892 filed February 3, 2026; hereafter “UniProt A4Z8Q1”) in view of Hussain et al. (International Journal of Food Properties 18:1288-1297, 2015; cited on Form PTO-892 filed February 3, 2026; hereafter “Hussain”) is withdrawn in view of applicant’s amendment to claim 1 to recite “composition comprising: (a) a surfactant; and (b) an isolated polypeptide…” The combination of UniProt A4Z8Q1 and Hussain does not teach or suggest a surfactant.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over UniProt A4Z8Q1 in view of Hussain and Sharma, R. K. (PharmaTutor 2:17-29, 2014; cited on the attached Form PTO-892; hereafter “Sharma”). This rejection is necessitated by applicant’s amendment to claim 1.
As amended, claim 1 is drawn to a composition comprising:
a surfactant; and
an isolated polypeptide having lysozyme activity or an enzymatically active fragment thereof, wherein the polypeptide has at least 95% sequence identity with the amino acid sequence of SEQ ID NO: 1.
UniProt A4Z8Q1 teaches a buffalo (Bubalus bubalis) lysozyme from mammary gland tissue (p. 1, top). The amino acid sequence disclosed by UniProt A4Z8Q1 is identical to instant SEQ ID NO: 1 (see Appendix A sequence alignment at pp. 19-20 of the Office action filed February 3, 2026).
UniProt A4Z8Q1 does not teach isolating the buffalo lysozyme and including it in a composition with a surfactant.
Hussain teaches lysozyme is a commercially valuable enzyme applied in foods (p. 1288, Abstract; p. 1289, bottom). Hussain teaches there has been increasing demand for lysozyme due to its potent antimicrobial activity against a wide range of microorganisms and hence, in food preservation and safety (p. 1289, bottom). Hussain teaches a method for isolating buffalo milk lysozyme (p. 1288, Abstract; p. 1291, top).
Sharma teaches biocompatible, biodegradable, and/or nontoxic emulsion-based formulations of surfactants have great potential for applications in the food preparation and processing (p. 17, Abstract), teaches surfactants are involved in the production of many common food items (p. 26, column 1, top), and teaches surfactant molecules, which are an important part of the food emulsions, play a key role in determining the microstructure of the product and in affecting its structural and textural stability in the food (p. 28, column 2). Sharma discusses at length surfactants in food industries (pp. 20-25) and applications of food emulsifiers/surfactants in food industries (pp. 26-28).
In view of the combined teachings of UniProt A4Z8Q1, Hussain, and Sharma, it would have been obvious to one of ordinary skill in the art before the effective filing date to include isolated buffalo lysozyme of UniProt A4Z8Q1 in a food composition with a surfactant. One would have been motivated to do this because UniProt A4Z8Q1 teaches a lysozyme, Hussain taught lysozyme is a commercially valuable enzyme applied in foods and teaches there has been increasing demand for lysozyme due to its potent antimicrobial activity against a wide range of microorganisms, and Sharma taught surfactants are involved in the production of many common food items. One would have expected success because UniProt A4Z8Q1 taught a buffalo lysozyme from mammary gland tissue and Hussain taught a method for isolating a buffalo milk lysozyme.
Therefore, the composition of claim 1 would have been obvious to one of ordinary skill in the art before the effective filing date.
RESPONSE TO REMARKS: Applicant argues that the composition of claim 1 is not directed to antimicrobial use in food preservation but is rather for preventing, reducing, or removing microbial growth on a textile after a wash cycle. Applicant cites to Figures 1 and 2 for evidence of this utility. Applicant argues Hussain does not teach or suggest reducing microbial growth following a cleaning process and one of ordinary skill would have recognized that an enzyme useful for food preservation would not necessarily be effective in a cleaning composition to reduce microbial load on a textile.
Applicant’s arguments are not found persuasive. The claims do not recite and are not limited to using the claimed composition for preventing, reducing, or removing microbial growth on a textile after a wash cycle. Given a broadest reasonable interpretation, the claims encompass a food composition comprising the isolated buffalo lysozyme of UniProt A4Z8Q1 and a surfactant and for the reasons set forth above, the composition of claim 1 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date.
Claims 26, 27, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Carpenter in view of UniProt Database Accession Number A0A0C5AGQ3 (December 11, 2019, 2 pages; cited on Form PTO-892 mailed February 3, 2026; hereafter “UniProt A0A0C5AGQ3”). This rejection has been modified from its previous version in order to address applicant’s amendment to the claims.
Carpenter teaches an antimicrobial composition comprising a ruminant stomach lysozyme (column 6, lines 52-53) with ruminant stomach lysozyme C being preferred for use (column 5, lines 41-42). Carpenter teaches ruminant stomach lysozyme is a lysozyme characteristic of the stomach mucosa of mammals with foreguts (column 1, lines 24-25) and teaches “rumen (foregut)” (column 5, line 21), which one of ordinary skill in the art would recognize that Carpenter is teaching “rumen” as another name for “foregut.” Carpenter teaches the antimicrobial composition can be formulated as a laundry detergent (column 7, lines 24-25; column 10, lines 41-46).
The difference between claim 26 and Carpenter is that Carpenter does not teach a polypeptide having an amino acid sequence having at least 95% sequence identity with the amino acid sequence of SEQ ID NO: 1 and having lysozyme activity.
UniProt A0A0C5AGQ3 teaches a buffalo (Bubalus bubalis) lysozyme C from rumen tissue (see p. 1, top and middle). The amino acid sequence disclosed by UniProt A0A0C5AGQ3 is identical to instant SEQ ID NO: 1 (see Appendix B sequence alignment at pp. 21-22 of the Office action filed February 3, 2026).
In view of the combined teachings of Carpenter and UniProt A0A0C5AGQ3, it would have been obvious to one of ordinary skill in the art before the effective filing date to use the buffalo lysozyme of UniProt A0A0C5AGQ3 in the detergent composition of Carpenter. One would have been motivated and would have expected success to use the buffalo lysozyme of UniProt A0A0C5AGQ3 in the detergent composition of Carpenter because Carpenter taught the composition comprises a ruminant stomach lysozyme, preferably a ruminant stomach lysozyme C, Carpenter taught ruminant stomach lysozyme is a lysozyme characteristic of the stomach mucosa of mammals with rumens, and UniProt A0A0C5AGQ3 taught a lysozyme C from rumen tissue of a buffalo, which is a mammal.
Regarding claim 27, Carpenter teaches the antimicrobial composition comprises a detergent surfactant (column 7, lines 17-19) and teaches detergent composition components including proteases (column 8, lines 45-46).
Regarding claim 31, since the “at least one additional polypeptide” including nuclease in claim 27 is optional, the prior art need not teach the nuclease of claim 31. See MPEP 2111.04.
Therefore, the detergent composition of claims 26, 27, and 31 would have been obvious to one of ordinary skill in the art before the effective filing date.
RESPONSE TO REMARKS: Applicant argues that while the instant specification provides evidence that the claimed detergent composition has the superior and surprising technical effect of preventing, reducing, or removing microbial growth on a textile after a wash cycle, the combination of cited prior art fails to teach or suggest such a technical effect and therefore, according to applicant, the examiner’s obviousness rationale is based on improper hindsight analysis.
Applicant’s arguments are not found persuasive. Regarding applicant’s argument that the combination of cited prior art fails to teach or suggest the technical effect of preventing, reducing, or removing microbial growth on a textile after a wash cycle, the claims do not recite preventing, reducing, or removing microbial growth on a textile after a wash cycle. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See MPEP 2145.VI. Even assuming arguendo the claims had been amended to recite preventing, reducing, or removing microbial growth on a textile after a wash cycle, such an effect would not have been surprising given Carpenter’s teachings that compositions comprising lysozyme exhibit antimicrobial activity. For example, Carpenter teaches “[t]he compositions herein can also be used periodically for removal and prevention of microbial growth” (column 10, lines 56-57).
Regarding applicant’s argument that the examiner’s obviousness rationale is based on improper hindsight analysis, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See MPEP 2145.X.A. In this case, the obviousness rationale is based only on knowledge that was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure. As such, contrary to applicant’s position, the obviousness rationale is not based on improper hindsight analysis.
Conclusion
Status of the claims:
Claims 1, 6, 8-11, 17-21, 23, 26, 27, and 31 are pending.
Claims 6, 8-11, 17-21, and 23 are withdrawn from consideration.
Claims 1, 26, 27, and 31 are rejected.
No claim is in condition for allowance.
THIS ACTION IS MADE FINAL. 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 DAVID J STEADMAN whose telephone number is (571)272-0942. The examiner can normally be reached Monday to Friday, 7:30 AM to 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MANJUNATH N RAO can be reached on 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/David Steadman/Primary Examiner, Art Unit 1656
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