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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4-24-2026 has been entered.
The amendment filed on 4-24-2026 is acknowledged. Claims 10 and 12 have been amended. Claims 14-17 have been added. Claims 10, 12 and 14-17 are pending and currently under examination.
Claim Rejections Maintained
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
Claims 10, 12 and 14-17 are rejected 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 for the reasons set forth in the previous Office action in the rejection of claims 10 and 12. 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 claim explicitly tie the "skin improvement" to the mechanistic endpoints (increased collagen or HA) as directly supported by Example 2.
2. Example 2 shows actual fermentation of this strain and measurement of the effect by the fermented product on hyaluronic acid/collagen synthesis. With the amendment, this should be considered as constituting an actual reduction to practice of the claimed invention.
3. Examples 3 and 4 demonstrate increased HA and collagen synthesis in skin- related cells in vitro.
4. In contrast to Ariad and Centocor, the present claims recite a single deposited strain and its fermentation product, which was actually produced and tested in the examples (Examples 2-4) in the specification. The "fermentation product" tied to the identified strain, which was actually prepared and tested in the examples, does not transform the claim into a vast, undefined genus. The present specification disclosed the actual preparation of the fermented product with the specific strain Saccharomyces cerevisiae strain deposited under Accession No. KCTC 14268BP, and disclosed experimental data with the fermented product for the effect recited in the claims.
Applicant’s arguments have been fully considered and deemed non-persuasive.
With regard to Point 1, contrary to Applicant’s assertion, there is no limitation with regard to what constitutes the claimed fermentation product or the means by which they are produced. As set forth in the rejection the process steps in producing a given fermentation product can have a drastic effect on its biological and immunological characteristics.
With regard to Points 2-4, there is no limitation with regard to how the “fermentation products” encompassed by claims 10, 12, 15 and 17 are obtained. Moreover, while there are some active steps set forth in claims 14 and 16, they do not correlate to the production of fermentation product disclosed in the specification. Consequently, the fermentation products of the rejected claims are merely being described by function.
As set forth previously, the instant claims are drawn to the utilization of pharmaceutical compositions comprising a fermentation production of the Saccharomyces cerevisiae strain deposited under the Accession No. KCTC 14268BP wherein said fermentation products improve the skin (i.e. increase skin moisture, improve wrinkles, enhance elasticity, promote hyaluronic acid production, promote collagen synthesis or is anti-aging).
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 skin therapeutics, Applicant must adequately describe the specific fermentation product that give rise to the recited “skin improvements” as well as the specific culture conditions required for the production of a given fermentation product. Additionally, Applicant must describe the dosages and means administered required to achieve said improvements.
However, with the exception of the of the “fermentation product” produced by the specific steps set forth in Example 2, the specification does not disclose any composition that has any of the claimed biological characteristics (and those are limited to the in vitro increase in the production of hyaluronic acid and collagen synthesis). The specification is silent with regard to any in vivo efficacious application of any composition comprising a fermentation product of the recited Saccharomyces cerevisiae strain and is equally silent with regard to dosages and methods of application. Consequently, the specification fails to disclose distinguishing and identifying features of a representative number of members of the genus of skin therapeutics which the claims are drawn, such as a correlation between the components of the compositions (and the means to produce them) and its recited function (i.e. increasing skin moisture, improving wrinkles, enhancing elasticity, promoting hyaluronic acid production, promoting collagen synthesis and is anti-aging) so that the skilled artisan could immediately envision, or recognize at least a substantial number of members of the claimed genus of skin therapeutics. Therefore, since the specification fails to adequately describe at least a substantial number of members of the genus of skin 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
Claim Rejections - 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 10, 12 and 14 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 10 is rendered vague and indefinite by the use of the term “anti-aging”. It is unclear what is meant to be engendered by said phrase. Said term in not defined in the specification which merely states:
"aging" refers to a phenomenon in which biological structures and functions decline over time, and as used herein, the "anti-aging" is not limited to the degree of improvement, as long as aging is improved, such as prevention, suppression, or delay of aging.
This does not constitute a clear definition of said term. Moreover, it is unclear what criteria is used to determine whether a given composition is “anti-aging”. Consequently, it is impossible to determine the metes and bounds of the claimed invention.
Claim 12 is rendered vague and indefinite by the use of the term “anti-aging”. It is unclear what is meant to be engendered by said phrase. Said term in not defined in the specification which merely states:
"aging" refers to a phenomenon in which biological structures and functions decline over time, and as used herein, the "anti-aging" is not limited to the degree of improvement, as long as aging is improved, such as prevention, suppression, or delay of aging.
This does not constitute a clear definition of said term. Moreover, it is unclear what criteria is used to determine whether a given composition is “anti-aging”. Consequently, it is impossible to determine the metes and bounds of the claimed invention. Applicants are directed to MPEP 2173.05(s) “Reference to Figures or the specification where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).” Since the testing methodologies are easily presented in simple language reference to the specification does not fall under the category of "exceptional circumstance".
Claim 15 is rendered vague and indefinite by the use of the phrase “…under the test conditions described in Example 2 of the specification.”. Applicants are directed to MPEP 2173.05(s) “Reference to Figures or the specification where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).” Since the testing methodologies are easily presented in simple language reference to the specification does not fall under the category of "exceptional circumstance".
Conclusion
No claim is allowed.
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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 June 9, 2026
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