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
Claims 1, 3 and 11 are currently pending.
Claim Rejections – Withdrawn – Overcome by Amendment
The rejection of claims 1-2 under 35 U.S.C. 102(a)(1) as being anticipated by Maddocks et al. (Nature, volume 544, pages 372–376 (2017)) is withdrawn.
The rejection of claims 1-3 and 10 under 35 U.S.C. 102(a)(1) as being anticipated by Maddocks (US20220117943A1, published April 21, 2022) is withdrawn.
The above rejections were overcome by Applicant’s amendment to the claims.
Claim Rejections – 35 USC § 112(a) – New Matter
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, 3 and 11 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. 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. This is a new matter rejection.
The Applicant amended claim 1 to specify that the composition comprises 8-20% alanine. The Applicant amended claim 11 to specify that the composition comprises 10-20% alanine. Claim 3 is a method that depends on claim 1. These ranges are new matter. The specification does not provide support for these ranges. The specification gives support for 4-20% alanine (Specification, p. 2, 3) and > 6% alanine (Specification, p. 14, 16). The specification gives specific examples with 4, 6, 8 and 10% alanine out of total amino acids (Specification, p. 14-15). The Applicant demonstrates that compositions comprising 6, 8 and 10% alanine are superior to 4% alanine (Fig. 4). However, the specification does not specifically mention 8-20% alanine or 10-20% alanine.
The Applicant alleges that the newly claimed ranges (8-20% and 10-20%) are different inventions than the originally disclosed range of 4-20% which overlaps the previously cited prior art ranges. The Applicant argues that the composition comprising 8% alanine provides unexpectedly improved palatability and that 8-20% alanine shows higher tumor growth suppression than the control group (Remarks, p. 4). Therefore, the claimed ranges are new matter.
Claim Rejections – 35 USC § 102 – New grounds of Rejection Necessitated by Amendment
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.”
Claim 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abe et al. (US2007/0276029 A1, published Nov. 29, 2007).
Claim 1 is directed towards an amino acid composition that affects tumor growth, characterized in that the amino acid composition is devoid of serine and glycine and comprises proline and 8-20 wt% alanine.
Abe teaches amino acid compositions devoid of serine and glycine, comprising proline and comprising 8.7% and 9.9% alanine, falling within the claimed range:
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541
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Specification, p. 4, paragraph [0047].
A conversion to weight percent is shown below. The mole percent is multiplied to the molar mass to get total grams and then normalized to the total mass to obtain the weight percent:
Example 1 (V10):
Amino Acid
mole %
molar mass (g/mol)
mole%*molar mass
wt%
Proline
37.5
115.1
4317.4
35.1
Alanine
12.0
89.1
1069.1
8.7
Valine
11.5
117.2
1347.2
11.0
Isoleucine
8.9
131.2
1167.4
9.5
Lysine
21.1
146.2
3084.6
25.1
Glutamine
9.0
146.1
1315.3
10.7
Total Mass
12301.0
Comparative example 1 (V9):
Amino Acid
mole %
molar mass (G/MOL)
mole%*molar mass
wt%
Proline
41.2
115.1
4743.4
39.8
Alanine
13.2
89.1
1176.1
9.9
Valine
12.6
117.2
1476.1
12.4
Isoleucine
8.6
131.2
1128.1
9.5
Lysine
23.2
146.2
3391.6
28.5
Glutamine
0.0
146.1
0.0
0.0
Total Mass
11915.2
Abe teaches that the compositions impart energy and promote motor function (Abe, Specification, p. 1, paragraphs [0013] and [0016]), and does not mention the effect on tumor growth. The intended use of the composition, however, is not further limiting to the composition (MPEP 2111.02.II).
Therefore, claim 1 is anticipated.
Claim Rejections – 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
“A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.”
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abe et al. (US2007/0276029 A1, published Nov. 29, 2007).
The rejection of claim 1 is incorporated herein by reference. Given the teachings of Abe, claim 1 was prima facie obvious at the time of filing.
Claim 11 is directed towards the amino acid composition according to claim 1, wherein the amino acid composition comprises 10-20 wt% alanine. As shown above, Abe teaches amino acid compositions comprising 8.7 wt% and 9.9 wt% alanine. A prima facie case of obviousness exists when claimed ranges or amounts are very close to the prior art (MPEP § 2144.05). Abe discloses 9.9 wt% which is very close to 10%. These values are so similar that one of ordinary skill in the art would have a reasonable expectation that similar results could be achieved from the claimed composition and the prior art composition. Therefore, claim 11 was prima facie obvious at the time of filing.
Conclusion
No claim is found to be allowable.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HEATHER DAHLIN whose telephone number is (571)270-0436. The examiner can normally be reached 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached on (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HEATHER DAHLIN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629