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 .
Claim Status
The amended claim set filed 20 March 2023 is acknowledged. Claims 1-7 are currently pending. Of those, no claims are currently amended, and claims 6-7 are new. No claims are cancelled. Claims 1-7 will be examined on the merits herein.
Priority
The application claims priority to KR10-2020-0122716 and is a 371 of PCT/KR2020/014460. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, a English translation of the priority document has not been filed, so for the sake of searching the art, the effective filing date being used for claims 1-7 is 22 Oct 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 20 March 2023 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. A signed copy of the statement is attached with this action.
Claim Objections
Applicant is advised that should claim 3 be found allowable, claim 5 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Applicant has not provided a special definition to differentiate between a “food composition” and a “feed composition”, so the two terms appear to have the same meaning.
Claim 7 is objected to because of the following informalities: the species name Lactobacillus sakei should be italicized to match conventions in the art and the other claims. Appropriate correction is required.
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.
Claim 6 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.
The parenthetical phrase in “MRS broth (Difco laboratories, USA)” renders the phrase indefinite, because the parentheses performs a similar function as the phrase “for example” and it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). One of ordinary skill in the art would not be able to determine whether MRS broth obtained from other sources is claimed. Also, claim 6 contains the trademark/trade name Difco. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe MRS broth and, accordingly, the identification/description is indefinite.
The term “improve the physiological activity” in claim 6 is a relative term which renders the claim indefinite. The terms “improve” and “physiological activity” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. One of ordinary skill in the art would not be able to determine what types of “physiological activities” must be improved and to what degree. Also, one of ordinary skill in the art would not be able to determine whether this claim requires evolutionary modifications to the bacterial strain, in which case it would no longer be the parental L. sakei Probio-65 strain and would instead be a different, improved strain, or whether the claim only requires “improvements” to the culture as a whole such as increasing the ratio of live-to-dead cells and converting the live cells to an actively growing, non-dormant state, in which case the bacteria would still be live bacteria from the parental L. sakei Probio-65 strain.
In the interest of compact prosecution, in this action, claim 6 will be interpreted as using any MRS broth from any source, and interpreted as “improving the physiological activity” by converting the cell culture to a live, actively growing state. Applicant is warned that claiming an evolutionary improvement to the L. sakei Probio-65 strain would raise issues under 35 U.S.C. 112(d) for broadening the parent claim by claiming a strain other than the L. sakei Probio-65 strain in claim 1 and 35 U.S.C. 112(a) by requiring a deposit of the evolved, improved strain.
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Claims 2 and 7 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Regarding claim 2, the claim requires that “the Lactobacillus sakei Probio-65 is a Lactobacillus sakei Probio-65 culture medium”. The specification does not provide a special definition of the term “Lactobacillus sakei Probio-65” as referring both to a bacteria and a culture media, so one of ordinary skill in the art would read claim 1 as requiring the composition to comprise a bacteria as an active ingredient. The re-definition of the probiotic strain as being not a bacterial strain but instead being a culture medium improperly broadens claim 2 and fails to include the limitation of the parent claim requiring that a bacteria be in the composition.
Regarding claim 7, the claim requires that “the Lactobacillus sakei Probio-65 is isolated from Kimchi, a traditional Korean fermented food.” However, the instant specification teaches that this is the source of the Lactobacillus sakei Probio-65 [0002]. Claim 7 does not limit the L. sakei Probio-65 strain of claim 1 because it only recites the inherent characteristic of the strain’s source.
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 1-2 and 6-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
Regarding claims 1 and 7, the claims recite a composition comprising: Lactobacillus sakei Probio-65 as an active ingredient. This strain is a strain that was isolated from kimchi, claim 7 and [0002]. Therefore, the strain is a natural isolate (i.e. a product of nature). The process of formulating this strain into a generic composition, whose only structural feature is comprising the bacteria as an active ingredient, does not give the strain markedly different products relative to the natural bacterial product. The specification does not disclose that the bacteria are changed or that the composition has properties that are not due to the bacteria. See MPEP 2106.04(c).II.C.2: In Myriad, the Supreme Court made clear that not all changes in characteristics will rise to the level of a marked difference, e.g., the incidental changes resulting from isolation of a gene sequence are not enough to make the isolated gene markedly different. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. This judicial exception is not integrated into a practical application because the intended use in the preamble results from the properties of the natural isolate rather than being a markedly different property resulting from formulation into a non-natural composition. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because no additional elements are claimed; the natural bacteria is the only structural element.
Regarding claims 2 and 6, the product-by-process is defined based on how the L. sakei Probio-65 is cultured, but there is no evidence of record that the culture conditions affect the properties of the naturally occurring bacterial strain. See MPEP 2106.04(c).I.B and 2113. Therefore, the strain produced by the claimed method appears to be the same as the natural isolate. The composition would not have markedly different characteristics, is not integrated into a practical application, and does not include additional elements for the same reasons as for claims 1 and 7 above.
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)(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.
Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park et al. (US-20090214497-A1; hereafter Park; PTO-892).
Regarding claims 1 and 7, Park teaches L. sakei Probio-65 strain isolated from kimchi [0034-0036], as well as a composition comprising the L. sakei Probio-65 [0039].
Regarding claim 2, Park also teaches compositions comprising cultures of L. sakei Probio-65 [0039], and teaches cultures of the bacteria [0062, 0065].
Regarding claims 3 and 5, Park teaches “a feed composition comprising Lactobacillus sakei Probio-65 or a culture thereof” [0051]. Park also teaches “a food (or heath functional food) composition comprising Lactobacillus sakei Probio-65 or a culture thereof” [0053]. Also, Park teaches that L. sakei Probio-65 strain was isolated from kimchi [0034-0036], so kimchi is a food/feed composition that must comprise components that can be considered a culture medium for L. sakei Probio-65, because the strain was alive in the food.
Regarding claim 4, Park teaches “a cosmetic composition comprising a culture of Lactobacillus sakei Probio-65” [0056].
Regarding claim 6, Park teaches “The Probio-65 strain isolated in Example 1 was cultured in MRS medium (Difco) at 37°C” [0062]. Instant claim 6 is a product-by-process claim. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113. The strain with “improved physiological activity” is interpreted in this action as being an actively-growing culture with a good ratio of live-to-dead cells. In view of this interpretation, the Park actively growing L. sakei Probio-65 strain in the MRS culture appears to be the same as the claimed actively growing L. sakei Probio-65 strain following one additional subculture. The instant specification does not disclose any differences in the actively growing strains chosen after subculturing different numbers of times. Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983). See also MPEP 2113.
Regarding the preamble of claims 1-2 and 6-7, Park does not teach that the composition has the intended use of “prevention or treatment of Alzheimer's disease”. However, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112. Park teaches all structural properties of the claimed invention, so the previously unappreciated use does not make the old composition patentably new.
Other Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Park (WO-2019078558-A1; PTO-892) has been reviewed, but the reference is not prior art under 102(a)(2) because it does not name another inventor and it is eligible for the exception 102(b)(1)(A) because the instant inventor is the only author of the ‘558 reference.
Park et al. (WO-2020105894-A1; PTO-892) teaches compositions comprising live L. sakei Probio-65 cells (pg. 3 par. 3-4). This reference shares author Park with the instant application, so it appears likely to be eligible for 102(b)(1)(A) and 102(b)(2)(A) exceptions. It would be appreciated if applicant confirmed whether the reference is eligible for the exceptions.
Liu et al. (first published 8 July 2020; made of record IDS 20 Mar 2023) teaches a composition comprising live L. sakei Probio-65 cells and teaches the use of the probiotic to reverse the malformed eye in transgenic GMR-Aβ42 Drosophila (Abstract). This reference shares author Liong with the instant application, so it appears likely to be eligible for 102(b)(1)(A) exception. It would be appreciated if applicant confirmed whether the reference is eligible for the exception.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIA NICOLE DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-R 8:30-4:30, and every other F 8:30-4:30 (EDT/EST).
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/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/GARY B NICKOL/Supervisory Patent Examiner, Art Unit 1645