DETAILED CORRESPONDENCE
Application Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-16 are pending and examined on the merits.
The text of those sections of Title 35 U.S. Code not included in the instant action can be found in the prior Office Action.
Drawings
The Drawings filed on 11/27/2023 are acknowledged and accepted by the examiner.
Priority
Acknowledgement is made of this continuation application of Non-provisional Application No. 18/519523, filed on 8/9/2024, which claims foreign priority under 35 U.S.C. 119(a)-(d) to Korean Patent Application No. KR10-2022-0165810, filing date 12/1/2022 and KR10-2013-0153047, filing date 11/7/2023. The certified copy has been filed in the present application on 3/18/2024.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Claim Objections
Claim 2 is objected to because of the following informalities: use of the following phrase ‘and motor function of 2.’ In the interest of improving claim form, it is suggested that applicants amend the claim to properly recite the context of the number ‘2.’ Appropriate correction is suggested.
Claims 7,8, 15, 16 are objected to because of the following informalities: use of the following phrase ‘wherein the aldehyde dehydrogenase is contained in lysate of any one or a mixture thereof selected from the group consisting of KCTC13925BP, KCTC14122BP,KCTC14123BP KCTC14983BP, KCTC 14984BP and KCTC 14985BP.’ In the interest of improving claim form, it is suggested that applicants provide the specific names of the microorganism that is connected with each of the deposit accession number listed in said claims. Appropriate correction is suggested.
Claim Rejections - 35 USC § 112(b)
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 1 - 16 are 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.
Regarding claims 1-2 (claims 3-7 dependent thereof), 9-10 (claims 11-15 dependent thereof) the term "gene" renders the claim indefinite because the term “gene” itself is overly broad and its scope is unclear because it is generally understood in the art that a “gene” includes sequences such as the promoter, introns and exons, untranslated regions and other controlling sequences. However, SEQ ID NO: 1 does not clearly show such demarcation of such regions. It is suggested Applicant amend the claims to replace ‘gene’ with ‘polynucleotide.’
Regarding claims 2 (claims 3-7 dependent thereof), 10 (claims 12-15 dependent thereof) the phrase "the gene of SEQ ID NO: 1 including SEQ ID NO: 2" renders the claim indefinite because SEQ ID NO: 2 shows that it is just an oligonucleotide of 42 nucleotides. As such, it is unclear what the phrase “by including”means. It is unclear if SEQ ID NO: 2 is included at the 5”end, 3” end or randomly within a region in SEQ ID NO: 1. Appropriate correction is suggested.
Claim 3 (claims 4-6 dependent thereof) recites the limitation 'the aldehyde' in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. There is no prior recitation of ‘aldehyde’ in independent claim 1. The term “aldehyde” recited in claim 1 is with reference to the enzyme and not the product “aldehyde.” However, claim 3 appears to be referring to the product “aldehyde” and therefore lacks antecedence. Furthermore, the claim also refers to it as “endogenous aldehyde.” There is no subject, host, or microorganism recited in claim 1 and therefore this recitation that the aldehyde is endogenous is indefinite. Appropriate correction is suggested.
Claims 5, 13 recites the limitation 'endogenous amine compound' in line 3 (claims 5, 13). There is insufficient antecedent basis for this limitation in the claim. There is no prior recitation of ‘endogenous amine compound’ in independent claims 1, 9. The phrase “endogenous amine compound” is indefinite as it is not clearly defined in the instant application claims. Appropriate correction is suggested.
Claims 7, 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. Claim 7 recites the phrase ‘…and motor function of 2.’ There is no indication what the recitation ‘2’ is referencing. Additionally, as recited, claim 16 is in dependent form due to the recitation ‘the pharmaceutical.’ It is suggested that Applicant amend claim 16 to recite ‘A pharmaceutical.’ In the interest of compact prosecution, Examiner will examine claim 16 as reciting ‘A pharmaceutical.’
Claim 11 (claims 12-14 dependent thereof) recites the limitation 'the aldehyde' in line 2. There is insufficient antecedent basis for this limitation in the claim. There is no prior recitation of ‘aldehyde’ in independent claim 9 and claim 10, upon which claim 11 depends. The term “aldehyde” recited in claim 9 is with reference to the enzyme and not the product “aldehyde.” However, claim 11 appears to be referring to the product “aldehyde” and therefore lacks antecedence. Furthermore, the claim also refers to it as “endogenous aldehyde.” There is no subject, host, or microorganism recited in claim 9, also claim 10 upon which claim 9 depends, and therefore this recitation that the aldehyde is endogenous is indefinite. Appropriate correction is suggested.
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 (i.e., changing from AIA to pre-AIA ) 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)(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 8, 16 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kwon et al (Patent No. US 11,618,889 B2, Date Filed: Feb 16, 2021, Examiner cited) {herein Kwon}.
Claim 8 is drawn to a food composition for improving behavior and motor function, further comprising aldehyde dehydrogenase contained in lysate of any one or a mixture thereof selected from the lysates of group of microorganisms consisting of KCTC13925BP, KCTC14122BP,KCTC14123BP KCTC14983BP, KCTC 14984BP and KCTC 14985BP.
Claim 16 is drawn to the pharmaceutical composition for suppressing and preventing Parkinson's disease, comprising aldehyde dehydrogenase contained in lysate of any one or a mixture thereof selected from the group consisting of KCTC13925BP, KCTC14122BP, KCTC14123BP KCTC14983BP, KCTC14984BP and KCTC14985BP. Applicant is reminded that claim 16 is being interpreted as reciting a ‘pharmaceutical composition for suppressing and preventing Parkinson's disease, comprising aldehyde dehydrogenase contained in lysate of any one or a mixture thereof selected from the group consisting of KCTC13925BP, KCTC14122BP, KCTC14123BP KCTC14983BP, KCTC14984BP and KCTC14985BP’ to facilitate prosecution.
With respect to claim 8, Kwon teaches mutant strains of Saccharomyces cerevisiae, KCTC13925BP, KCTC14122BP, KCTC14123BP, with high levels of aldehyde dehydrogenase (column 5, lines 21-26; lines 30-32) and glutathione to reduce ROS, improve cognitive function and disease prevention (column 1, lines 31-34, 41-42). Absent evidence otherwise, it is the Examiner’s position that the treatment of cognitive disorders, taught by Kwon, includes the recited Parkinson’s disease (instant application claim 8) as it is known by those of ordinary skill in the art that Parkinson’s disease is a cognitive disorder that affects behavioral and motor functioning. Kwon further teaches that KCTC13925BP, KCTC14122BP, KCTC14123BP are utilized in food and medicines for the treatment of glutathione deficiencies (column 1, lines 55-59). In addition, Kwon teaches the aldehyde dehydrogenase is located within the lysate of the microorganism (column 12, lines 15).
With respect to claim 16, Kwon teaches strains of Saccharomyces cerevisiae, KCTC13925BP, KCTC14122BP, KCTC14123BP, with high amount of aldehyde dehydrogenase (column 5, lines 21-26; lines 30-32) and glutathione to reduce ROS and improve cognitive function (column 1, lines 31-34, 41-42). Absent evidence otherwise, it is the Examiner’s position that the treatment of cognitive disorders, taught by Kwon, includes the recited Parkinson’s disease (claim 16) as it is known by those of ordinary skill in the art that Parkinson’s disease is a cognitive disorder that affects behavioral and motor functioning. Kwon further teaches that KCTC13925BP, KCTC14122BP, KCTC14123BP are utilized in food and medicines for the treatment of glutathione deficiencies (column 1, lines 55-59). It is the Examiner’s position that the recitation of “medicines” is the same as a pharmaceutical composition.
For the reasons stated herein, the teachings of Kwon anticipate claims 8 and 16.
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.
Claims 1-7, 9-15 are rejected under 35 U.S.C. 103 as being unpatentable over Kwon et al (Patent No. US 11,618,889 B2, Date Filed: Feb 16, 2021, Examiner cited) {herein Kwon} in view of Pigeau et al (2005, Journal of Applied Microbiology, Examiner cited) {herein Pigeau}.
Claims 1-7 are drawn to a food composition for improving behavioral and motor function, containing aldehyde dehydrogenase encoded by a gene having more than 98% homology to the gene of SEQ ID NO: 1.
Claims 9-15 are drawn to a pharmaceutical composition for suppressing and preventing Parkinson's disease, containing aldehyde dehydrogenase encoded by a gene with more than 98% homology to the gene of SEQ ID NO: 1.
With respect to claims 1, 3, 4, 6, 7, 9, 11-12, 14, 15, Kwon teaches strains of Saccharomyces cerevisiae, KCTC13925BP, KCTC14122BP, KCTC14123BP, with high amount of aldehyde dehydrogenase (column 5, lines 21-26; lines 30-32) and glutathione to reduce ROS and improve cognitive function (column 1, lines 31-34, 41-42). Absent evidence otherwise, it is the Examiner’s position that the treatment of cognitive disorders, taught by Kwon, includes the recited Parkinson’s disease (claims 9-16) as it is known by those of ordinary skill in the art that Parkinson’s disease is a cognitive disorder that affects behavioral and motor functioning. Kwon further teaches that KCTC13925BP, KCTC14122BP, KCTC14123BP are utilized in food and medicines for the treatment of glutathione deficiencies (column 1, lines 55-59). It is the Examiner’s position that the recitation of “medicines” is the same as a pharmaceutical composition. Kwon further teaches acetaldehyde is a hangover causing substance that is produced by human cells via ethanol metabolism (column 3, lines 8-12). As such, absent evidence otherwise, it is the Examiner’s position that said acetaldehyde is an endogenous acetaldehyde.
However, Kwon does not teach the product of claims 1, 2, wherein aldehyde dehydrogenase encoded by a gene having more than 98% homology to the gene of SEQ ID NO: 1 (claims 1, 9). Kwon does not teach the product of claims 2, 10, wherein the aldehyde dehydrogenase is an aldehyde dehydrogenase encoded by the gene of SEQ ID NO:1 including SEQ ID NO: 2 (claims 2, 10). Kwon does not teach the product of claims 5, 13, wherein the endogenous amine compound is selected from the group consisting of dopamine, norepinephrine, serotonin, and gamma-aminobutyric acid (GABA) (claims 5, 13).
With respect to claims 1-2, 5, 9-10, 13, Pigeau teaches ALD3 (Aldehyde dehydrogenase [NAD(P)+] 2) from Saccharomyces cerevisiae exhibits an increase in glutamate dehydrogenase production and is upregulated in the presence of additional sugar (abstract). Absent evidence otherwise, it is the Examiner’s position that the instant application SEQ ID NO: 1 is the same as ALD3 taught by Pigeau as said sequences are 100% identical (Appendix A). Pigeau further teaches the utilization of Saccharomyces cerevisiae in the production of Canadian Icewine and the role of ALD3 in acetic acid production (abstract). Additionally, since the art teaches the structure of a food composition (Canadian Icewine) containing ALD3 from Saccharomyces cerevisiae, absent evidence otherwise, it is the Examiner’s position that the Canadian Icewine fermented with Saccharomyces cerevisiae containing ALD3, taught by Pigeau, would necessarily/ inherently have the same function and capability of improving behavioral and motor function as the claimed food composition. Furthermore, since SEQ ID NO: 2 of the instant application is 100% identical to SEQ ID NO: 1 of the instant application, it is the Examiner’s position that the ALD3 taught by Pigeau is the same as the claimed SEQ ID NO: 1 including SEQ ID NO: 2 (appendix B). Pigeau further teaches the production of succinate through the oxidation of glutamate that forms GABA (page 123, column 2, para 2), of which glutamate is an amine.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to apply the teachings of Kwon et al of strains of Saccharomyces cerevisiae, KCTC13925BP, KCTC14122BP, KCTC14123BP, with high amount of aldehyde dehydrogenase (column 5, lines 21-26; lines 30-32) and glutathione to reduce ROS and improve cognitive function (column 1, lines 31-34, 41-42) or combine the teachings of Pigeau because Pigeau teaches ALD3 from Saccharomyces cerevisiae exhibits an increase in glutamate dehydrogenase production and is upregulated in the presence of additional sugar (abstract).
One of ordinary skill in the art would be motivated to either use the teachings of Kwon et al. by itself or combine the teachings of Pigeau because Pigeau provides the motivation for Kwon to use ALD3 (instant application SEQ ID NO: 1), as said enzyme is not glucose repressed (abstract) and is upregulated in the presence of additional sugar (abstract). Said property would be advantageous as it does not require genetic manipulations to increase the synthesis of ALD3. One of ordinary skill in the art knowing the benefit of aldehyde dehydrogenase based on the teachings of Kwon and Pigeau would have a reasonable expectation of success to combine the aldehyde dehydrogenase ,ALD3, taught by Pigeau with the teachings of Kwon because one of ordinary skill in the art would expect them both to increase cognitive and behavioral functioning. One of ordinary skill in the art would have a reasonable expectation that the synthesis of ALD3 would be more cost and time effective for the production of food and pharmaceutical compositions as Pigeau teaches the simple additional of sugar to the fermentation medium caused a 7-fold upregulation of ALD3 (abstract). Thereby, not requiring additional genetic modifications. Additionally, Pigeau teaches ALD3 is not repressed by glucose (abstract), which makes it easier to cultivate.
One of skill in the art would have a reasonable expectation of success to make and use the claimed fusion protein because Kwon provides the basic teaching of improving cognitive functioning with the utilization of aldehyde dehydrogenase, while Pigeau provides the teaching of an aldehyde dehydrogenase (ALD3) that is not repressed by glucose, but is in-fact upregulated by glucose. Therefore there would be a reasonable expectation of success to arrive at the above invention. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
Status of Claims
Claims 1-16 are pending.
Claims 1-16 are rejected.
No claims are in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at 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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/ERICA NICOLE JONES-FOSTER/Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
Appendix A
Translation of the instant application SEQ ID NO: 1 vs Accession No. NP_013892
Best Local Similarity 100.0%;
Matches 506; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 512 MPTLYTDIEIPQLKISLKQPLGLFINNEFCPSSDGKTIETVNPATGEPITSFQAANEKDV 571
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MPTLYTDIEIPQLKISLKQPLGLFINNEFCPSSDGKTIETVNPATGEPITSFQAANEKDV 60
Qy 572 DKAVKAARAAFDNVWSKTSSEQRGIYLSNLLKLIEEEQDTLAALETLDAGKPFHSNAKQD 631
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 DKAVKAARAAFDNVWSKTSSEQRGIYLSNLLKLIEEEQDTLAALETLDAGKPFHSNAKQD 120
Qy 632 LAQIIELTRYYAGAVDKFNMGETIPLTFNKFAYTLKVPFGVVAQIVPWNYPLAMACRKMQ 691
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 LAQIIELTRYYAGAVDKFNMGETIPLTFNKFAYTLKVPFGVVAQIVPWNYPLAMACRKMQ 180
Qy 692 GALAAGNTVIIKPAENTSLSLLYFATLIKKAGFPPGVVNVIPGYGSVVGKALGTHMDIDK 751
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 GALAAGNTVIIKPAENTSLSLLYFATLIKKAGFPPGVVNVIPGYGSVVGKALGTHMDIDK 240
Qy 752 ISFTGSTKVGGSVLEASGQSNLKDITLECGGKSPALVFEDADLDKAIEWVANGIFFNSGQ 811
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 ISFTGSTKVGGSVLEASGQSNLKDITLECGGKSPALVFEDADLDKAIEWVANGIFFNSGQ 300
Qy 812 ICTANSRVYVQSSIYDKFVEKFKETAKKEWDVAGKFDPFDEKCIVGPVISSTQYDRIKSY 871
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 ICTANSRVYVQSSIYDKFVEKFKETAKKEWDVAGKFDPFDEKCIVGPVISSTQYDRIKSY 360
Qy 872 IERGKKEEKLDMFQTSEFPIGGAKGYFIPPTIFTDVPETSKLLRDEIFGPVVVVSKFTNY 931
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 IERGKKEEKLDMFQTSEFPIGGAKGYFIPPTIFTDVPETSKLLRDEIFGPVVVVSKFTNY 420
Qy 932 DDALKLANDTCYGLASAVFTKDVKKAHMFARDIKAGTVWINQTNQEEAKVPFGGFKMSGI 991
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 DDALKLANDTCYGLASAVFTKDVKKAHMFARDIKAGTVWINQTNQEEAKVPFGGFKMSGI 480
Qy 992 GRESGDTGVDNYLQIKSVHVDLSLDK 1017
||||||||||||||||||||||||||
Db 481 GRESGDTGVDNYLQIKSVHVDLSLDK 506
Appendix B
Instant Application SEQ ID NO: 1 vs Instant Application SEQ ID NO: 2
Query Match 1.4%; Score 42; DB 1; Length 42;
Best Local Similarity 100.0%;
Matches 42; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1492 AGATATAGATTATACACATTTAGAAAATTAGCCAAAAGAAAA 1533
||||||||||||||||||||||||||||||||||||||||||
Db 1 AGATATAGATTATACACATTTAGAAAATTAGCCAAAAGAAAA 42
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512
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380
932
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370
916
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