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 .
Claims 14, 16-21, 24, 28-31 are pending.
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 14, 16-21, 24, and 28-31 are not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, do not recite something significantly different than a judicial exception. The rationale for this determination is explained below:
The claims are directed to naturally occurring Pedicoccus cells in one of the following forms: freeze dried, lyophilized, microencapsulated, non-viable cells or a lysate, a fraction, a ferment, a metabolite, a extract, derivative, analog or mutant of the Pedicoccus strain.
Thus, claims in the broadest embodiment are drawn to a naturally occurring bacteria or a natural product derived from the naturally occurring bacteria, i.e. Pedicoccus cell and their natural by-products (for instance extract, metabolite) are not patent eligible merely because they have been isolated.
Applicant’s specification sets forth that the Pediococcus pentosaceus LB606R (DSM 33730) was isolated from homemade sauerkraut, kimchi and healthy human donor samples. (See page 24).
Accordingly, the instant claims encompass compositions comprising naturally occurring bacteria and are thereby deemed to be a judicial exception.
The Supreme Court in Diamond v. Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980), held a claim to a genetically engineered bacterium eligible, because the claimed bacterium was not a “product of nature” exception. (Emphasis added). As the Court explained, the modified bacterium was patentable because the patent claim was not to a “hitherto unknown natural phenomenon,” but instead had “markedly different characteristics from any found in nature,” due to the additional plasmids and resultant capacity for degrading oil. 447 U.S. at 309-10, 206 USPQ at 197.
Subsequent judicial decisions have made clear that the Supreme Court’s decision in Chakrabarty is “central” to the eligibility inquiry with respect to nature-based products. See, e.g., Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. _, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972, 1979 (2013). For example, the Federal Circuit has indicated that “discoveries that possess ‘markedly different characteristics from any found in nature,’ … are eligible for patent protection.” In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1336, 110 USPQ2d 1668, 1671 (Fed. Cir. 2014) (quoting Chakrabarty, 447 U.S. at 310, 206 USPQ2d at 197). In Roslin, the claimed invention was a live-born clone of a pre-existing, non-embryonic, donor mammal selected from cattle, sheep, pigs, and goats. An embodiment of the claimed invention was the famous Dolly the Sheep, which the court stated was “the first mammal ever cloned from an adult somatic cell.” Despite acknowledging that the method used to create the claimed clones “constituted a breakthrough in scientific discovery”, the court relied on Chakrabarty in holding the claims ineligible because “Dolly herself is an exact genetic replica of another sheep and does not possess ‘markedly different characteristics from any [farm animals] found in nature.’” Roslin, 750 F.3d at 1337, 110 USPQ2d at 1671. As the Pediococcus cells remain identical to the naturally occurring bacteria, the instantly claimed compositions are deemed to be a naturally occurring judicial exception.
Response to Arguments
Applicant's arguments filed 2/13/2026 have been fully considered but they are not persuasive.
Applicant argues that that the strain LB606R is different from what is found in nature since the strain is in one of the recited forms: freeze dried form lyophilized, microencapsulated, non-viable cells, a lysate, a fraction, a ferment, a metabolite, as a extract, derivative, analog or mutant thereof.
The broadest embodiments are still directed to a judicial exception. The specification does not indicate any genetic modification to the cell per se and applicant has not provided any evidence that the claims are directed to a genetically modified cell. For instance, a metabolite or extract that are derived from the claimed strain are naturally occurring products. Isolation of the metabolite/extract, etc does not make it patent eligible. Therefore, the broadest embodiments still reads on a judicial exception. The dependent claims are directed to intended use of the composition and do not change the structure of the judicial exception to produce a markedly different product.
Claim Rejections - 35 USC § 112
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 14, 16-18, 19-21, 24, 28-31 are rejected under 35 U.S.C. 112, first paragraph, as containing subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention, this is a written description rejection.
The claims recite Pediococcus pentosacaeus “fractions, ferment, metabolites, extracts, derivatives, analogues and mutants.”
The specification and claims do not indicate what distinguishing attributes are shared by the members of the genus. Thus, the scope of the claims includes numerous structural variants, and the genus is highly variant because a significant number of structural differences between genus members is permitted. Since the disclosure fails to describe the common attributes or characteristics that identify members of the genus, and because the genus is highly variant, "fractions, ferment, metabolites, extracts, derivatives, analogues and mutants” are insufficient to describe the genus. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus. Thus, applicant was not in possession of the claimed genus.
Adequate written description requires more than a mere statement that it is part of the invention and a reference to a potential method of isolating it. The protein itself is required. See Fiers v. Revel, 25 USPQ 2d 1601 at 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Lts., 18 USPQ2d 1016.
Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 111, clearly states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed."
Applicant is reminded that Vas-Cath make clear that the written description provision of 35 USC 112 is severable from its enablement provision.
Furthermore, in The Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus by only their functional activity does not provide an adequate written description of the genus. The court indicated that while Applicants are not required to disclose every species encompassed by a genus, the description of a genus is achieved by the recitation of a representative number of DNA molecules, usually defined by a nucleotide sequence, falling within the scope of the claimed genus. At section B(1), the court states that "An adequate written description of a DNA... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention."
Response to Arguments
Applicant's arguments filed 2/13/2026 have been fully considered but they are not persuasive. Applicant argues one skilled in the art understands the distinguishing attributes shared by the genus members and that one would recognize these terms have well established meaning and are universally recognized as biologically related forms from a common material.
These arguments have been considered and it is not disputed that the terms are known in the art; however the instant specification lacks structure function correlation. In fact the instant specification in the background discusses the inability of lactic acid bacteria from preventing biofilm or lack of antimicrobial activity in vivo. The specification states that this inability to prevent biofilm formation is due to the prior art not being able to select the strains for their antimicrobial activity and there is a need in the art to maintain the antimicrobial activity in cocultures. See page 5. The specification teaches LB606R and LB679R is capable of inhibiting biofilm and pathogenic Candida species in terms of the Pediococcus. The specification does not describe any derivatives, mutants, analogs, fraction, extract/metabolites or what metabolites/extracts would retain this function since clearly applicant’s background discusses that not all lactic acid bacteria retain the function. The lack of description of any specific metabolites, analogs, derivatives, extracts, demonstrates applicant does not have possession of the entire genus claimed. The specification does not sufficiently describe what derivatives fall within the scope and still retain their property of inhibiting biofilm formation and pathogenic Candida species. Additionally the specification does not describe any analogues that have the functional characteristics claimed. Similarly the specification does not describe any extract(s) or metabolite(s); the strains produce varied extracts and metabolites. Thus, in light of the lack of guidance in the specification, the rejection is maintained.
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 20-21 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).
Amended claim 20 recites, “The composition according to claim 19, wherein the non-viable cells are provided as a lysate, as a fraction, as a ferment, as metabolites, as an extract, as a derivative, as analogues, or as a mutant of one of the Pediococcus strains.” Claim 19 has been amended to depend on claim 14 which recites “an isolated Pedicoccus pentosaceus LB606R.” Thus, the recitation” one of the Pediococcus strains” lacks antecedent basis. Claim 21 does not resolve the deficiency and is included in this rejection.
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.
Claim 19-20 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.
Base claim 14 is directed to a composition comprising “LB606R, deposited under the accession number DSM 33730 is stabilized in freeze dried, lyophilized or microencapsulated forms; or is non-viable cells, as a lysate, as a fraction, as a ferment, as metabolites, as an extract, as a derivative, as analogues, or as a mutant of the Pediococcus pentosaceus LB606R, deposited under the assession number DSM 33730.”
Amended claim 19 (amended to depend on claim 14) is directed to “wherein the Pediococcus pentosaceus LB606R, deposited under the deposit accession number DSM 33730 is provided as viable cells, as non-viable cells, as a lysate, or as a supernatant” and thus directed to a broader scope. The supernatant and viable cells are the broader embodiments.
Claim 20 is directed to “The composition according to claim 19, wherein the non-viable cells are provided as a lysate, as a fraction, as a ferment, as metabolites, as an extract, as a derivative, as analogues, or as a mutant of one of the Pediococcus strains.” Claim 20 depends on claim 19 which depends on claim 1. Claim 14 limits the claim to on strain, LB606R. Instant claim is directed to one of the Pediococcus strains which is the broader scope .
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.
Claim Rejections - 35 USC § 102
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.
Claim(s) 24 and 28-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olmstead et al.
The claims are directed to a medical composition comprising one or more Pediococcus strains.
Olmstead et al (US Publication 2012/0315249) disclose of pharmaceutically acceptable compositions comprising Pediococcus. (See claim 25).
If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000) (holding that the preamble phrase "which provides improved playing and handling characteristics" in a claim drawn to a head for a lacrosse stick was not a claim limitation). Compare Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333-34, 68 USPQ2d 1154, 1158 (Fed. Cir. 2003) (In a claim directed to a method of treating or preventing pernicious anemia in humans by administering a certain vitamin preparation to "a human in need thereof," the court held that the preamble is not merely a statement of effect that may or may not be desired or appreciated, but rather is a statement of the intentional purpose for which the method must be performed. Thus the claim is properly interpreted to mean that the vitamin preparation must be administered to a human with a recognized need to treat or prevent pernicious anemia.); In re Cruciferous Sprout Litig., 301 F.3d 1343, 1346-48, 64 USPQ2d 1202, 1204-05 (Fed. Cir. 2002) (A claim at issue was directed to a method of preparing a food rich in glucosinolates wherein cruciferous sprouts are harvested prior to the 2-leaf stage. The court held that the preamble phrase "rich in glucosinolates" helps define the claimed invention, as evidenced by the specification and prosecution history, and thus is a limitation of the claim (although the claim was anticipated by prior art that produced sprouts inherently "rich in glucosinolates")).
A composition and its properties are inseparable. Therefore, if the prior art teaches the identical composition (Pediococcus strains), the properties applicant discloses and/or claims (inhibition of biofilm/treatment of skin) are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Accordingly, Olmstead et al disclose of each and every limitation of the instantly filed claims.
Claim(s) 24 and 28-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Munivar et al.
The claims are directed to a medical composition comprising one or more Pediococcus strains.
Munivar et al (US Publication 2018/0161380) disclose of pharmaceutically acceptable compositions comprising Pediococcus for treating skin conditions. (See claim 1). Regarding the newly added wherein clause, a composition and its properties are inseparable. Therefore, if the prior art teaches the identical composition (Pediococcus strains), the properties applicant discloses and/or claims (inhibition of biofilm/treatment of skin) are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Accordingly, Munivar et al disclose of each and every limitation of the instantly filed claims.
Response to Arguments
Applicant's arguments filed 2/13/2026 have been fully considered but they are not persuasive.
Applicant argues that the claims have been amended to recite the ‘intended use’ limitations positively, i.e the claims are limited to treating skin and inhibiting yeast biofilm.
The claims are directed to a product, i.e. a composition comprising Pediococcus in a freeze dried, lyophilized, microencapsulated, non-viable cells or a lysate, a fraction, a ferment, a metabolite, a extract, derivative, analog or mutant of the cell. If the prior art teaches the structural limitations as claimed, then it is capable for performing the intended use. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP 2112.01.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 SHARMILA G. LANDAU whose telephone number is (571)272-0614. The examiner can normally be reached Monday-Friday 6-3:30.
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/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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