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 1-9 are pending in this application and are being examined on the merits.
Priority
The instant application is a continuation application of U.S. non-provisional application no. 16/329,759, filed 02/28/2019 (abandoned), which is a national stage filing under 35 U.S.C. 371 of PCT/KR2017/004537, filed 04/28/2017, which claims foreign priority to Korean Application No. 10-2016-0111042, filed 08/30/2016.
Should the applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d), a certified English translation of the foreign priority document must be submitted. Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 05/24/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the examiner.
Foreign Patent Document 9 of the information disclosure statement filed 05/24/2024 has been lined through because there is no copy of this reference in the application file.
Objections to Specification
The disclosure is objected to because of the following informalities.
The Sequence Listing must be referenced by a statement in the specification identifying (i) the name of the file; (ii) the date of creation; and (iii) the size of the file in bytes according to 37 CFR 1.834.c.1, however the specification at [para 8] filed on 08/14/2024 states the size of the file in kilobytes.
Appropriate correction is required.
Claim Objections
Claim 7 is objected to for the phrase “wherein the strain is one or both of a Leuconostoc mesenteroides strain … and a Lactobacillus sakei strain”. In the interest of improving claim form, Applicant should consider an amendment to recite “wherein the strain comprises a Leuconostoc mesenteroides strain having the deposit accession number KCCM11827P, a Lactobacillus sakei strain having the deposit accession number KCCM11841P, or both.
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.
Claims 4-5 and 7-9 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP 2173.05(c).
In the present instance, claim 4 is confusing in the recitation of
“a concentration of 5 x 104 to 5 x 108 CFU/ml is administered 1 to 4 times, 30 ml to 100 ml each time, daily” because claim 4, which depends from claim 3, encompasses a daily dose that exceeds the daily dose recited in claim 3. For example, claim 3 recites
“a daily dose of the Leuconostoc holzapfelii Ceb-kc-003 strain is from 1.5 x 105 to 5 x 1010 CFU” and claim 4 encompasses a maximum dosage of 5 x 108 CFU/ml administered 4 times, 100 ml each time corresponding to 2 x 1011 CFU, which exceeds the daily dosage range set forth in claim 3.
Claim 5 is indefinite for the phrase “wherein the strain is further effective in ameliorating erectile dysfunction”, as it is unclear whether the limitation is intended to require that the method ameliorate erectile dysfunction in the subject or the limitation is merely reciting a characteristic of the strain. Applicant is advised that if claim 5 is intended to be interpreted as meaning the method ameliorates erectile dysfunction in the subject, it is unclear whether or not the subject is or is not required to have erectile dysfunction and if the subject does not have erectile dysfunction, how the administering of the strain achieves the result of ameliorating erectile dysfunction. It is suggested that applicant clarify the meaning of the claim.
Claim 7 is indefinite for the phrase “wherein the strain is one or both”, referring to a choice between two individual strains and the combination of the two strains. As claim 7 depends from claim 6, which recites administering the strain of the genus Leuconostoc or Lactobacillus in the alternative, the recitation of the phrase in claim 7 encompasses the administration of two strains which contradicts the limitation “the method according to claim 1, further comprising administering a strain” recited in claim 6 that corresponds to further administering a single strain.
Claim 8 is indefinite for the phrase “wherein the composition includes a culture solution, a concentrate, or a dried product of the strain”. As written, it is unclear whether the phrase “of the strain” is referring to all of the alternatives recited in the claim, i.e., the culture solution, the concentrate, and the dried product, or if the phrase “of the strain” is referring only to the dried product. For example, it is unclear whether the claim encompasses the alternatives of a culture solution of the strain and a concentrate of the strain, or if the claim encompasses any culture solution and any concentrate not derived from the strain.
Claim 9 is indefinite for the phrase “wherein administering the composition ameliorates erectile dysfunction”, as it is unclear whether or not the subject is or is not required to have erectile dysfunction and if the subject does not have erectile dysfunction, how the administering of the strain achieves the result of ameliorating erectile dysfunction. It is suggested that applicant clarify the meaning of the claim.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 USC 112(d), as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. This rejection is based on the interpretation of claim 5 as merely reciting a characteristic of the strain. Claim 5 recites “the method of claim 1, wherein the strain is further effective in ameliorating erectile dysfunction”. The recited property of “effective in ameliorating erectile dysfunction” is presumed to be inherent to the strain recited in claim 1 (see MPEP 2112.01.I). Given that the strain of claim 1 already is “effective in ameliorating erectile dysfunction”, claim 5 does not further limit claim 1.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 USC § 112(a)
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.
Claims 1-9 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claims recite a Leuconostoc holzapfelii strain Ceb-kc-003 deposited under the Budapest treaty on August 11, 2016 at the Korean Culture Center of Microorganism under an accession number KCCM11830P, a Leuconostoc mesenteroides strain deposited under the Budapest treaty on April 06, 2016 at the Korean Culture Center of Microorganism under an accession number KCCM11827P, and a Lactobacillus sakei strain deposited under the Budapest treaty on June 01, 2016 at the Korean Culture Center of Microorganism under an accession number KCCM11841P. It is apparent that the recited bacterial strains are required to practice the claimed invention. Since the biological material is required for the claimed invention, it must be obtainable by a reproducible method set forth in the specification or otherwise be readily available to the public. If the biological material is not so obtainable or available, the requirements of 35 U.S.C. 112 may be satisfied by a deposit of the biological materials.
The recited Leuconostoc holzapfelii strain Ceb-kc-003 is disclosed in the specification [para 48] as having been deposited at Korean Culture Center of Microorganisms under an accession number KCCM11830P since April 11, 2016 in accordance with the Budapest Treaty. The recited Leuconostoc mesenteroides strain is disclosed in a letter filed 05/24/2024 as having been deposited under the Budapest treaty on April 06, 2016 at the Korean Culture Center of Microorganism under an accession number KCCM11827P, and the recited Lactobacillus sakei is disclosed in a letter filed 05/24/2024 as being deposited under the Budapest treaty on June 01, 2016 at the Korean Culture Center of Microorganism under an accession number KCCM11841P
However, it is unclear if the deposits meet all the criteria set forth in 37 CFR 1.801-1.809. For example, the Applicant has not stated that restrictions on the availability to the public of the materials so deposited will be irrevocably removed upon the granting of a patent. If the deposit was made under the Budapest treaty, then an affidavit or declaration by Applicant or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature and registration number, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirement made herein.
Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number in the following manner:
SUGGESTION FOR DEPOSIT OF BIOLOGICAL MATERIAL
A declaration by applicant, assignee, or applicant's agent identifying a deposit of biological material and stating the following may be sufficient to overcome an objection and rejection based on a lack of availability of biological material:
Identifies declarant.
States that a deposit of the material has been made in a depository affording permanence of the deposit and ready accessibility thereto by the public if a patent is granted. The depository is to be identified by name and address.
States that the deposited material has been accorded a specific (recited) accession number.
States that all restriction on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
States that the material has been deposited under conditions that access to the material will be available during the pendency of the patent application to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C § 122.
States that the deposited material will be maintained with all the care necessary to keep it viable and uncontaminated for a period of at least five years after the most recent request for the furnishing of a sample of the deposited microorganism, and in any case, for a period of at least thirty (30) years after the date of deposit for the enforceable life of the patent, whichever period is longer.
That he/she declares further that all statements made therein of his/her own knowledge are true and that all statements made on information and belief are believed to be true, and further that these statements were made with knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under section 1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of the instant patent application or any patent issuing thereon.
Alternatively, it may be averred that deposited material has been accepted for deposit under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the purpose of Patent Procedure (e.g., see 961 OG 21, 1977) and that all restrictions on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
Additionally, the deposit must be referred to in the body of the specification and be identified by deposit (accession) number, date of deposit, name and address of the depository and the complete taxonomic description.
Citation of Relevant Prior Art
Wolf et al. (J Mol Med, 2003, 81:110; cited on the attached Form PTO-892) relates to nitric oxide in the human hair follicle [title], and discusses that nitric oxide (NO) is an important mediator in processes such as blood flow and wound healing [abstract]. Wolf further discloses that human hair follicles produce NO, wherein basal NO level is enhanced when stimulated with 5-alpha-dihydroxytestosterone (DHT), indicating NO to play a role in the regulation of hair follicle activity [abstract].
Burnett et al. (J Clin Hypertension, 2006, 8:53; cited on the attached Form PTO-892) relates to the role of NO in erectile dysfunction [title], and discusses the role of NO as a main vasoactive nonadrenergic, noncholinergic neurotransmitter and mediator of penile erection [abstract].
Sobko et al. (Nitric Oxide, 2005, 13:272; cited on the attached Form PTO-892) relates to the generation of NO by gastrointestinal bacteria [title], and discusses that bacteria from the genera Lactobacillus and Bifidobacterium generate NO from nitrite, and NO generation in the gut lumen has been correlated with microbiota comprising these bacteria [abstract].
Conclusion
Status of the Application:
Claims 1-9 are pending.
Claims 1-9 are rejected.
No claim is in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH SPANGLER whose telephone number is (571)270-0314. The examiner can normally be reached M-F 7:30 am - 4:30 pm.
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/JOSEPH R SPANGLER/
Examiner
Art Unit 1656
/David Steadman/Primary Examiner, Art Unit 1656