The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
The amendment filed on 4-17-2026 is acknowledged. Claim 1 has been amended. Claims 2 and 6-12 have been canceled. Claims 1-and 3-5 are pending and currently under examination.
Priority
Receipt is acknowledged of the certified English translation of the foreign application and therefore the claim for benefit based on the non-English application is deemed perfected.
Claim Objections
The objection of claim 1 for reciting claim language drawn to a non-elected invention is withdrawn in light of the amendment thereto.
Claim Rejections Withdrawn
The rejection of claims 1-5 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement (biological deposit) requirement is withdrawn.
Claim Rejections Maintained
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Written Description
The rejection of claims 1 and 3-5 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is maintained for reasons of record. The cancellation of claim 2 has rendered the rejection of that claim moot. The claim(s) contains 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 or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant argues:
1. The amended claims are now directed only to the subject matter the Office has admitted on record has written description support.
Applicant’s arguments have been fully considered and deemed non-persuasive.
With regard to Pont 1, contrary to Applicant’s assertion, the rejected claims are not drawn to subject matter that has proper written description. As clearly set forth in the rejection, “…the specification is silent with regard to any in vivo efficacious application of any composition comprising the B. longum CCFM752, a culture thereof or a fermentation product thereof to prevent any cardiovascular disease is equally silent with regard to dosages and methods of application”. Examples 2-5 are limited to the in vitro effects of Bifidobacterium longum CCFM752 culture supernatant on A7R5 rat thoracic aortic smoot muscle cells. This limited disclosure cannot be extrapolated to in vivo methods of preventing hypertension regardless of its etiology.
The instant claims are drawn to the utilization of a Bifidobacterium longum CCFM752 deposited with the Guangdong Microbial Culture Collection Center (GDMCC) with the accession number of GDMCC No. 61157 culture supernatant to prevent hypertension regardless of its etiology.
To fulfill the written description requirements set forth under 35 USC § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. To adequately describe the genus of therapeutics, Applicant must adequately describe the specific culture conditions required for the production of “the culture supernatant” as well as the dosages and means administered required to achieve said prevention.
However, with the exception of the of the specific “B. longum CCFM752 culture supernatant” utilized in Examples 2-5 and the ability of B. longum CCFM752 to reduce hypertension the specification is silent with regard to any in vivo efficacious application of any composition comprising the B. longum CCFM752 or culture supernatant thereof to prevent hypertension regardless of its etiology.
Moreover, Wang et al. (Microorganism Vol. 9, 452, pages 1-12) clearly demonstrates the unpredictability of the in vivo therapeutic effects of B. longum CCFM752 supernatants when they state:
“...the metabolites of probiotic strains CCFM752, CCFM1149, and CCFM10 exert antioxidative effects on A7R5 through different intracellular pathways. Thus, these probiotic strains have the potential of preventing cardiovascular diseases. Further studies are needed to testify their effects on animal models and human beings, and their physiological properties, such as antibiotic resistance, virulence, as well as the dose-effect relationships, should also be examined before the industrialization of these probiotic strains” (see Conclusions section on page 10).
Consequently, the specification fails to disclose distinguishing and identifying features of a representative number of members of the genus of therapeutics which the claims are drawn, such as a correlation between the components of the compositions (and the means to produce and administer them) and its recited function (i.e. preventing hypertension) so that the skilled artisan could immediately envision, or recognize at least a substantial number of members of the claimed genus of therapeutics. Therefore, since the specification fails to adequately describe at least a substantial number of members of the genus of therapeutics to which the claims refer, the written description requirement is not satisfied.
MPEP § 2163.02 states, “[a]n objective standard for determining compliance with the written description requirement is, 'does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed' ”. The courts have decided:
The purpose of the “written description” requirement is broader than to merely explain how to “make and use”; the 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.
See Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991). Furthermore, the written description provision of 35 USC § 112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
MPEP 2163.02 further states, “[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention” See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed.
Moreover, the describing of a biological entity by their functions was addressed in the Centocor decision (CENTOCOR ORTHO BIOTECH, INC. v ABBOTT LABORATORIES (Fed Cir, 2010-1144, 2/23/2011)). In said case the court stated”
To satisfy the written description requirement, "the 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,' and demonstrate that by disclosure in the specification of the patent." Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541 F.3d 1115, 1122 (Fed. Cir. 2008) (quoting Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir. 1991)). Assessing such "possession as shown in the disclosure" requires "an objective inquiry into the four corners of the specification." Ariad, 598 F.3d at 1351. Ultimately, "the specification must describe an invention understandable to [a person of ordinary skill in the art] and show that the inventor actually invented the invention claimed." Id. A "mere wish or plan" for obtaining the claimed invention is not adequate written description. Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1566 (Fed. Cir. 1997).
The court further opined that Centocor's suggestion
that our decision in Noelle and the PTO written description guidelines support the view that fully disclosing the human TNF-α protein provides adequate written description for any antibody that binds to human TNF-α. That suggestion is based on an unduly broad characterization of the guidelines and our precedent.
The court concluded that
While our precedent suggests that written description for certain antibody claims can be satisfied by disclosing a well-characterized antigen, that reasoning applies to disclosure of newly characterized antigens where creation of the claimed antibodies is routine. Claiming antibodies with specific properties, e.g., an antibody that binds to human TNF-α with A2 specificity, can result in a claim that does not meet written description even if the human TNF-α protein is disclosed because antibodies with those properties have not been adequately described.
New Grounds of Rejection
35 USC § 112
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 3-5 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.
Claim 3 recites the limitation "the product" in 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the product" in 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 is rendered vague and indefinite by the use of the phrase “…wherein in the product, the viable count of the B. longum CCFM752 is not less than 1 x 106 CFU/mL or 1 x 106 CFU/g.”. It is unclear how a supernatant (which by definition is clarified) can contain any viable cells. As written, it is impossible to determine the metes and bounds of the claimed invention.
Claim 5 recites the limitation "the product" in 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 is rendered vague and indefinite by the use of the phrase “… the B. longum CCFM752 is added to the food or the B. longum CCFM752 is used as a fermentation strain for food fermentation. It is unclear what is meant to be engendered by said phrase as the independent claim is limited the administration of a supernatant. As written, it is impossible to determine the metes and bounds of the claimed invention.
Conclusion
No claim is allowed.
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.
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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 April 28, 2026
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