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 .
DETAILED ACTION
STATUS OF THE CLAIMS: Claims 1-7 are pending in this application.
Election/Restrictions
Applicant's election of species in the reply filed on July 31, 2025 is acknowledged. All claims were be examined.
Claim Rejections - 35 USC § 112, 2nd paragraph
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 1-7 (including claims dependent thereon) ejected 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 pre-AIA the applicant regards as the invention.
Regarding claim 1, the phrase “branched chain amino acids or metabolites or a composition comprising branched chain amino acid metabolites” renders the claim indefinite because the claim include elements not actually disclosed (those encompassed by " branched chain amino acids or metabolites or a composition comprising branched chain amino acid metabolites"), thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05(d). Are all branched chain amino acids or metabolites or a composition comprising branched chain amino acid metabolites intended? The claim is extremely broad. Appropriate correction in required.
Claim Rejections - 35 USC § 112, 1st paragraph
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.
Claims 1-7 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claims contain 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.
The issue is concerning the meaning of “branched chain amino acids or metabolites or a composition comprising branched chain amino acid metabolites” in Claim 1 does not contain a specific compound name, generic formula or structure indicating structural makeup for Applicant’s invention.
According to the MPEP § 2163, “a question as to whether a specification provides an adequate written description may arise in the context of an original claim which is not described sufficiently (see, e.g., LizardTech, Inc. v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1345, 76USPQ2d 1724, 1733 (Fed. Cir. 2005); Enzo Biochem, 323 F.3d at 968, 63 USPQ2dat 1616 (Fed. Cir. 2002); Eli Lilly, 119 F.3d 1559, 43 USPQ2d 1398), a new or amended claim wherein a claim limitation has been added or removed, or a claim to entitlement of an earlier priority date or effective filing date under 35 U.S.C. 119, 120, or 365(c). Most typically, the issue will arise in the context of determining whether new or amended claims are supported by the description of the invention in the application as filed (see, e.g., In re Wright, 866 F.2d 422, 9 USPQ2d 1649 (Fed. Cir. 1989)), whether a claimed invention is entitled to the benefit of an earlier priority date or effective filing date under 35 U.S.C. 119, 120, or 365(c) (see, e.g., New Railhead Mfg. L.L.C. v.Vermeer Mfg. Co., 298 F.3d 1290, 63 USPQ2d 1843 (Fed. Cir. 2002); Tronzo v. Biomet, Inc., 156 F.3d 1154, 47 USPQ2d 1829 (Fed. Cir. 1998); Fiers v. Revel, 984F.2d 1164, 25 USPQ2d 1601 (Fed. Cir. 1993); In re Ziegler, 992 F.2d 1197, 1200, 26USPQ2d 1600, 1603 (Fed. Cir. 1993)), or whether a specification provides support for a claim corresponding to a count in an interference (see, e.g., Fields v. Conover, 443 F.2d1386, 170 USPQ 276 (CCPA 1971)).
Compliance with the written descriptionrequirement is a question of fact, which must be resolved on a case-by-case basis. Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116 (Fed. Cir. 1991). There is a strong presumption that an adequate written description of the claimed invention is present when the application is filed. In re Wertheim, 541 F.2d 257, 263,191 USPQ 90, 97 (CCPA 1976) (“we are of the opinion that the PTO has the initial
burden of presenting evidence or reasons why persons skilled in the art would not
recognize in the disclosure a description of the invention defined by the claims”).
However, as discussed in paragraph I., supra, the issue of a lack of adequate written
description may arise even for an original claim when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the applicant had possession of the claimed invention. The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art.
For example, consider the claim “A gene comprising SEQ ID NO:1.” A determination of what the claim as a whole covers may result in a conclusion that specific structures such as a promoter, a coding region, or other elements are included. Although all genes encompassed by this claim share the characteristic of comprising SEQ ID NO:1, there may be insufficient description of those specific structures (e.g., promoters, enhancers, coding regions, and other regulatory elements) which are also included. The claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.
For example, even though a genetic code table would correlate a known
amino acid sequence with a genus of coding nucleic acids, the same table cannot predict the native, naturally occurring nucleic acid sequence of a naturally occurring mRNA or its corresponding cDNA. Cf. In re Bell, 991 F.2d 781, 26 USPQ2d 1529 (Fed. Cir. 1993), and In re Deuel, 51 F.3d 1552, 34 USPQ2d 1210 (Fed. Cir. 1995) (holding that a process could not render the product of that process obvious under 35 U.S.C. 103). The Federal Circuit has pointed out that under United States law, a description that does not render a claimed invention obvious cannot sufficiently describe the invention for the purposes of the written description requirement of 35 U.S.C. 112. Eli Lilly, 119 F.3d at 1567, 43 USPQ2d at 1405. Compare Fonar Corp. v. General Electric Co., 107 F.3d 1543, 1549, 41 USPQ2d 1801, 1805 (Fed. Cir. 1997) (“As a general rule, where software constitutes part of a best mode of carrying out an invention, description of such a best mode is satisfied by a disclosure of the functions of the software. This is because, normally, writing code for such software is within the skill of the art, not requiring undue experimentation, once its functions have been disclosed. Thus, flow charts or source code listings are not a requirement for adequately disclosing the functions of software.”).
A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a “laundry list” disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not “reasonably lead” those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967) (“If n-
propylamine had been used in making the compound instead of n-butylamine, the
compound of claim 13 would have resulted. Appellants submit to us, as they did to the
board, an imaginary specific example patterned on specific example 6 by which the
above butyl compound is made so that we can see what a simple change would have
resulted in a specific supporting disclosure being present in the present specification. The trouble is that there is no such disclosure, easy though it is to imagine it.”) (emphasis in original); Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1328, 56 USPQ2d 1481, 1487 (Fed. Cir. 2000) (“the specification does not clearly disclose to the skilled artisan that the inventors ... considered the ratio... to be part of their invention .... There is therefore no force to Purdue’s argument that the written description requirement was satisfied because the disclosure revealed a broad invention from which the [later-filed] claims carved out a patentable portion”).”
Applicants are reminded of what the U.S. Court of Appeals Federal Circuit wrote in University of California v. Eli Lilly and Co. 43 USPQ2d 1398, “[I]n claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass. One skilled in the art can distinguish such a formula from others and can identify many of the species that the claims encompass. According, such a formula is normally an adequate description of the claimed genus.” “A definition by function, as we have previously indicated, doesn’t not suffice to define the genus because it is only an indication of what the gene does, rather than what it is. See Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen).” It is only a definition of a useful result rather than a definition of what achieves that result.” “The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”)”.
Examiner suggests amending claim 1 to include “branched chain amino acids or metabolites or a composition comprising branched chain amino acid metabolites” intended (i.e., incorporate claim 6 into claim 1), including all of the limitations.
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.
Claims 1-7 (including claims dependent thereon or relate back to other claims) are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moinard et al. (WO2015/052086).
Applicant claims a method for reducing hepatic triglycerides and/or improving glucose metabolism in an individual, comprising administering branched chain amino acids or metabolites or a composition comprising branched chain amino acid metabolites to the individual.
This reference discloses Applicant’s methods on pages 1-3 and 20-22. (See Abstract, Examples and entire document ). These methods read on the instant claim. Since this reference teaches the exact compounds, Applicant’s claims are anticipated, and thus, rejected under 35 U.S.C. 102.
Claims 1-7 (including claims dependent thereon or relate back to other claims) are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sathyavageeswaran et al. (US Pub. 2015/025143).
Applicant claims a method for reducing hepatic triglycerides and/or improving glucose metabolism in an individual, comprising administering branched chain amino acids or metabolites or a composition comprising branched chain amino acid metabolites to the individual.
This reference discloses Applicant’s methods on paragraphs [0008]-[0014], [0042]-[0046]. (See Abstract, Examples, Tables and pages 7-8). These methods read on the instant claim. Since this reference teaches the exact compounds, Applicant’s claims are anticipated, and thus, rejected under 35 U.S.C. 102.
Claims 1-7 (including claims dependent thereon or relate back to other claims) are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pakiet et al. (Obesity Surgery’2020).
Applicant claims a method for reducing hepatic triglycerides and/or improving glucose metabolism in an individual, comprising administering branched chain amino acids or metabolites or a composition comprising branched chain amino acid metabolites to the individual.
This reference discloses Applicant’s methods on pages 304, 308-310. (See Abstract, Tables and entire document ). These methods read on the instant claim. Since this reference teaches the exact compounds, Applicant’s claims are anticipated, and thus, rejected under 35 U.S.C. 102.
Claims 1-7 (including claims dependent thereon or relate back to other claims) are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mardinoglu et al. (EBioMedicine’2018).
Applicant claims a method for reducing hepatic triglycerides and/or improving glucose metabolism in an individual, comprising administering branched chain amino acids or metabolites or a composition comprising branched chain amino acid metabolites to the individual.
This reference discloses Applicant’s methods on pages 153-155. (See Abstract and entire document ). These methods read on the instant claim. Since this reference teaches the exact compounds, Applicant’s claims are anticipated, and thus, rejected under 35 U.S.C. 102.
Claims 1-7 (including claims dependent thereon or relate back to other claims) are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jang et al. (Nat Med’2016).
Applicant claims a method for reducing hepatic triglycerides and/or improving glucose metabolism in an individual, comprising administering branched chain amino acids or metabolites or a composition comprising branched chain amino acid metabolites to the individual.
This reference discloses Applicant’s methods on pages 2-6. (See Abstract and entire document ). These methods read on the instant claim. Since this reference teaches the exact compounds, Applicant’s claims are anticipated, and thus, rejected under 35 U.S.C. 102.
Claims 1-7 (including claims dependent thereon or relate back to other claims) are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shen et al. (WO2014/094279).
Applicant claims a method for reducing hepatic triglycerides and/or improving glucose metabolism in an individual, comprising administering branched chain amino acids or metabolites or a composition comprising branched chain amino acid metabolites to the individual.
This reference discloses Applicant’s methods on pages 1-6 and 12-15. (See Abstract and entire document ). These methods read on the instant claim. Since this reference teaches the exact compounds, Applicant’s claims are anticipated, and thus, rejected under 35 U.S.C. 102.
Conclusion
Claims 1-7 are pending. Claims 1-7 are rejected. No claims are allowed.
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/PAUL V WARD/ Primary Examiner, Art Unit 1622