DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-19 have been canceled.
Claims 27-39 have been added.
Claims 20-39 are currently pending.
Election/Restrictions
Applicant’s election without traverse of Group II, Claims 20-26, in the reply filed on 9/30/2025 is acknowledged.
Claims 27-39 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions and species, there being no allowable generic or linking claims.
Claims 20-26 are being examined in this application.
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 20-26 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.
Claim 20 is directed to a composition comprising fructosyl-amino acid oxidase. Fructosyl-amino acid oxidase is naturally occurring. There is no indication in the instant specification that the claimed fructosyl-amino acid oxidase has any characteristics that are different from the naturally occurring fructosyl-amino acid oxidase. Thus, fructosyl-amino acid oxidase does not have markedly different characteristics from its natural counterpart in its natural state, and is “product of nature” exception. Accordingly, claim 20 is directed to an exception. Claim 20 does not include any additional features that could add significantly more to the exception. Therefore, claim 20 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim 21 recites the composition further comprises fructosamine 3 kinase and adenosine triphosphate. Fructosamine 3 kinase and adenosine triphosphate are naturally occurring. There is no indication in the instant specification that the claimed fructosamine 3 kinase and adenosine triphosphate have any characteristics that are different from the naturally occurring fructosamine 3 kinase and adenosine triphosphate. Thus, fructosamine 3 kinase and adenosine triphosphate do not have markedly different characteristics from their natural counterparts in their natural state, and are “product of nature” exceptions. Claim 21 as a whole does not amount to significantly more than each “product of nature” by itself. Accordingly, claim 21 is directed to an exception. Therefore, claim 21 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claims 22 and 25 recite the composition further comprises flavin adenine dinucleotide. Flavin adenine dinucleotide is naturally occurring. There is no indication in the instant specification that the claimed flavin adenine dinucleotide has any characteristics that are different from the naturally occurring flavin adenine dinucleotide. Thus, flavin adenine dinucleotide does not have markedly different characteristics from its natural counterpart in its natural state, and is “product of nature” exception. Accordingly, claims 22 and 25 are directed to an exception. Claims 22 and 25 do not include any additional features that could add significantly more to the exception. Therefore, claims 22 and 25 do not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim 23 recites the composition further comprises magnesium ions. Magnesium ions are naturally occurring. There is no indication in the instant specification that the claimed magnesium ions have any characteristics that are different from the naturally occurring magnesium ions. Thus, magnesium ions do not have markedly different characteristics from their natural counterparts in their natural state, and are “product of nature” exceptions. Accordingly, claim 23 is directed to an exception. Claim 23 does not include any additional features that could add significantly more to the exception. Therefore, claim 23 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim 24 recites the composition further comprises a peroxidase. Peroxidase is naturally occurring. There is no indication in the instant specification that the claimed peroxidase has any characteristics that are different from the naturally occurring peroxidase. Thus, peroxidase does not have markedly different characteristics from its natural counterpart in its natural state, and is “product of nature” exception. Accordingly, claim 24 is directed to an exception. Claim 24 does not include any additional features that could add significantly more to the exception. Therefore, claim 24 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim 26 recites the composition is in the form of drops, and does not include any additional features that could add significantly more to the exception in claim 20. Therefore, claim 26 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 20 and 24 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Rie et al (JP2010233502A; 10/21/2010.).
The instant claims recite a composition configured for administration to a subject's eye(s), wherein the composition comprises: fructosyl-amino acid oxidase, wherein the composition reduces advanced glycation end products (AGEs)-induced fluorescence in eye tissue of the subject.
Rie teaches a composition comprising fructosyl-amino acid oxidase (p.3 para 5). The composition further comprises a peroxidase (p.10 para 9).
Limitations of “configured for administration to a subject's eye(s)” and “wherein the composition reduces advanced glycation end products (AGEs)-induced fluorescence in eye tissue of the subject” in claim 20 are regarded as intended use limitations. The claiming of a new use, function or unknown property does not necessarily make the composition patentable. The intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103. (MPEP 2112)
Therefore the reference anticipates the claimed subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 of this title, 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.
Claims 20-23 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Aken et al (WO 2019/149648 A1; 8/8/2019. Cited on IDS) in view of Lin et al (Appl Microbiol Biotechnol. 2010;86:1613-1619.).
The instant claims recite a composition configured for administration to a subject's eye(s), wherein the composition comprises: fructosyl-amino acid oxidase, wherein the composition reduces advanced glycation end products (AGEs)-induced fluorescence in eye tissue of the subject.
Aken teaches a composition comprising a fructosamine-3-kinase, adenosine tri phosphate (p.5 line 7-8), and magnesium ions for use to treat cataract (p.5 line 7-8, p.8 line 9), wherein the composition is for external application such as drops (p.7 line 31).
Aken does not teach the composition comprises fructosyl-amino acid oxidase (claim 20), and flavin adenine dinucleotide (FAD) (claims 22 and 25).
However, Aken does teach the Maillard reaction and advanced glycation end-products (AGEs), AGEs play a role in the development of cataract (p.2 para 1), and the administration of a deglycating enzyme and its cofactor(s) is used to treat cataract (p.1 line 5-6). Lin teaches the Maillard reaction and the formation of amadori products and advanced glycation end-products (AGEs) (p.1613 Introduction), where fructosyl amine oxidases (FAOXs) are a relatively new class of enzymes that cleave amadori compounds formed by the Maillard reaction (Abstract), all known FAOXs require FAD (p.1614 col right – para 3), and as amadori compounds and AGEs have been implicated in aging and several diseases, the therapeutic use of FAOXs should be worth exploring (p.1618 col left – last para).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate fructosyl-amino acid oxidase, since Aken discloses that the administration of a deglycating enzyme and its cofactor(s) is used to treat cataract, and Lin discloses that fructosyl amine oxidases are deglycating enzymes that cleave amadori compounds, which have been implicated in aging and several diseases, that fructosyl amine oxidases require FAD (cofactor), and that the therapeutic use of fructosyl amine oxidases should be worth exploring. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to incorporate fructosyl-amino acid oxidase with a reasonable expectation for successfully obtaining a composition.
Limitations of “configured for administration to a subject's eye(s)” and “wherein the composition reduces advanced glycation end products (AGEs)-induced fluorescence in eye tissue of the subject” in claim 20 are regarded as intended use limitations. The claiming of a new use, function or unknown property does not necessarily make the composition patentable. The intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103. (MPEP 2112)
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759
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