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
This office action is in response to applicant’s communication filed on 7/2/25.
Claims 1, 3-4 and 6-20 are pending in this application. Claims 4, 6, 9-10, 12 and 18-20 are withdrawn as being non-readable on applicant’s elected group and elected species. The examiner corrects the typographical error in the office action filed on 3/25/25 that left out claims 10 and 20 in the withdrawn claims, since the claims do not read on applicant’s elected species: arginine and leucine as the two amino acids 1 and 2.
As a result, claims 1, 3, 7-8, 11 and 13-17 are being examined in this Office Action.
Claim Rejections – 35 USC 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148
USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 1 03(a) are summarized as follows:
Applicant Claims
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue, and resolving the level of ordinary skill in the pertinent art.
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.
Claims 1, 3, 7-8, 11 and 13-17 remain rejected under 35 U.S.C. 103(a) as being unpatentable over Lobmann et al. (WO 2018113891, pub date 6/28/18, in applicant’s IDS filed 7/14/23; US 20200146989, pub date 5/14/20, is being used herein as the US equivalent).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Lobmann et al. teaches co-amorphous formulations with a dipeptide which include one or two different amino acids. Lobmann et al. exemplifies co-amorphous formulations of Arg/Phe, Phe/Trp, Arg/Trp, Ser/Thr, Trp/Pro, Arg/Pro. (paragraph 4, 44, claim 26)
Abbreviations are as follows: phenylalanine (Phe), arginine (Arg), proline (Pro), tryptophan (Trp), serine (Ser), threonine (Thr).
Lobmann et al. teaches “tryptophan, arginine, lysine, isoleucine, leucine, methionine, and valine are known to be good stabilizers for the co-amorphous formulation, whereas phenylalanine, arginine and proline are known to enhance the dissolution rate of the drug substance” and that arginine and leucine are preferred amino acids. (paragraphs 5, 91)
Lobmann et al. also teaches “Given a specific substance, a dipeptide for forming a co-amorphous form may be selected based on the physicochemical properties of the individual components. From our studies it is known that some amino acids such as tryptophan, arginine, lysine, isoleucine, leucine, methionine, and valine show excellent amorphization properties. However, the same amino acids do not always lead to a high increase in dissolution rate, mainly because of their low apparent solubility. On the other hand, other amino acids such as proline, phenylalanine, and arginine lead to high dissolution rate and solubility increase, but do not always show good amorphization properties or may not result in satisfactory long-term physical stability.” (paragraph 55)
Thus Lobmann et al. teaches the equivalency of tryptophan and leucine, which are both known to be good stabilizers for the co-amorphous formulation (paragraph 5).
Lobmann et al. teaches a range of molar ratios for the components in the co-amorphous composition and exemplifies a 1:1 molar ratio for two amino acid co-amorphous compositions (paragraph 130, 132, Table 2, claims 34-37).
Lobmann et al. teaches the co-amorphous formulations can be formulated into a suitable application form dependent on the specific use of the form, which can include medical and cosmetic use. The co-amorphous form may be formulated into pharmaceutical or cosmetic compositions, which include oral administration. The co-amorphous compositions include pharmaceutical, cosmetic, veterinary, food or dietary compositions. (paragraphs 1 and 53)
Lobmann et al. teaches the molar ratio of the substance (one or two amino acids) and the dipeptide can range from about 1:99 to about 99:1 (claim 34 and paragraph 51).
Lobmann et al. teaches the need for new excipients to improve the solubility properties of co-amorphous formulations. (page 2, lines 10-11)
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Lobmann et al. is deficient in the sense that it does not teach exemplify applicant’s elected species of arginine and leucine co-amorphous composition. Instead Lobmann et al. teaches a co-amorphous formulation of arginine and tryptophan.
Lobmann et al. is also deficient in that it does not teach applicant’s molar ratios of 0.1 to 10 and 6:4 to 4:4 (claims 13 and 14).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
However, it would be prima facie obvious to one of ordinary skill in the art at the time of the invention, to substitute leucine for tryptophan in Lobmann et al.’s co-amorphous composition of arginine and tryptophan to form applicant’s co-amorphous composition of arginine and leucine, since Lobmann et al. teaches the equivalency of tryptophan and leucine, which are both known to be good stabilizers for co-amorphous formulations.
Thus, at the time of instant invention, a person of ordinary skill in the art would have been motivated to substitute leucine for tryptophan with a reasonable expectation of success. Note that an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).
With regard to applicant’s limitations regarding the molar ratios of the amino acids, it is the position of the examiner that one of ordinary skill in the art, at the time of the invention, would through routine and normal experimentation determine the optimization of the molar ratios to provide the best effective variable depending on the results desired. Because Lobmann et al. teaches a range of molar ratios for the components in the co-amorphous composition, the examiner asserts that the molar ratios of the amino acids are an art recognized result-effective variable. Furthermore, in Table 2, Lobmann et al. exemplifies 1:1 molar ratios for two amino acids in a co-amorphous formulation. Thus it would be obvious in the optimization process to optimize the molar ratios of the amino acids. The applicant does not show any unusual and/or unexpected results for the limitation stated. Note that the prior art provides the same effect desired by the applicant, the formation of a co-amorphous formulations that include two amino acids with excellent stabilizing properties.
With regard to applicant’s claim recitation of “consisting essentially of the amino acid 1 and the amino acid 2” in claim 2, the examiner responds by stating that the transitional phrase “consisting essentially of” limits the scope of a claim to the specified materials or steps “and those that do not materially affect the basic and novel characteristic(s)” of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976) (emphasis in original).
Thus for the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising.” See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355 (“PPG could have defined the scope of the phrase ‘consisting essentially of’ for purposes of its patent by making clear in its specification what it regarded as constituting a material change in the basic and novel characteristics of the invention.”).
If an applicant contends that additional steps or materials in the prior art are excluded by the recitation of “consisting essentially of,” applicant has the burden of showing that the introduction of additional steps or components would materially change the characteristics of applicant’s invention. In re De Lajarte, 337 F.2d 870, 143 USPQ 256 (CCPA 1964). See also Ex parte Hoffman, 12 USPQ2d 1061, 1063-64 (Bd. Pat. App. & Inter. 1989) (“Although ‘consisting essentially of’ is typically used and defined in the context of compositions of matter, we find nothing intrinsically wrong with the use of such language as a modifier of method steps. . . [rendering] the claim open only for the inclusion of steps which do not materially affect the basic and novel characteristics of the claimed method. To determine the steps included versus excluded the claim must be read in light of the specification… [I]t is an applicant’s burden to establish that a step practiced in a prior art method is excluded from his claims by ‘consisting essentially of’ language.”). (See MPEP 2111.03)
Furthermore, it would be reasonable to expect that since Lobmann et al. teaches the molar ratio of the substance (the two amino acids) and the dipeptide can be 99:1, this small dipeptide addition would not materially affect the basic and novel characteristics of the claimed co-amorphous composition, absent evidence to the contrary.
Response to Arguments
Applicant’s arguments have been considered but are not persuasive for the following reasons:
The examiner acknowledges applicant’s amendment of claim 1 to “consisting essentially of” instead of “comprising”. Applicant argues that since the Lobmann compositions require the presence of a drug and because applicant’s invention is to increase the solubility of the amino acids whereas Lobmann is directed the increase of the solubility of the drug, that Lobmann does not render the claimed compositions obvious.
The examiner does not agree with the applicant. Lobmann et al.’s “drug” is merely a dipeptide, a combination of two amino acids. Furthermore Lobmann et al. teaches the molar ratio of the substance (the two amino acids) and the dipeptide “drug” can be 99:1. Thus a 1% dipeptide addition would not materially affect the basic and novel characteristics of the claimed co-amorphous amino acid composition, absent evidence to the contrary. Furthermore, both Lobmann et al. and applicant’s invention are directed to excipients that improve solubilities, and both Lobmann et al. and applicant’s invention recognize that amino acids are the excipient that can impart solubility to less soluble compounds.
The examiner repeats by stating that the transitional phrase “consisting essentially of” limits the scope of a claim to the specified materials or steps “and those that do not materially affect the basic and novel characteristic(s)” of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976) (emphasis in original).
The examiner acknowledges applicant’s argument that the examiner’s reference to the PPG case law does not support the examiner’s argument that applicant’s “consisting essentially of” amended claim language can be read as “comprising”.
The examiner does not agree with the applicant’s argument. The examiner responds by stating that in the PPG case law, the court pointed out that the claim language must give appropriate notice as to what is covered. Using ambiguous transitional phrases or misdefining them undermines that.
Applicant’s claim language does not give clear notice, does not address this ambiguity, nor whether unrecited features could blur the claimed scope. Furthermore, applicant’s argue the particular fact pattern of the PPG case law, which is not the relevant issue. The PPG case law relates to transparent glass compositions used for architectural and automotive purposes, whereas applicant’s amino acid compositions are used for solubility purposes in the food and beverage industry.
Furthermore, applicant’s specification does not address if a small addition, such as Lobmann et al.’s teaching of 1% addition of a drug, would materially affect applicant’s claimed properties, such as the solubility, of the amino acid composition. In other words, applicant has not addressed the percentages and particular compounds that would materially affect applicant’s claimed compositions and thus be excluded in applicant’s “consisting essentially of” amended claim language. Again the court wants this to be clear, which the applicant has failed to do at this time.
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 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 Jennifer Cho Sawyer whose telephone number is (571) 270 1690. The examiner can normally be reached on Monday-Friday 9 AM - 6 PM PST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Renee Claytor can be reached on (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-274-1690.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Jennifer Cho Sawyer
Patent Examiner
Art Unit: 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691