DETAILED ACTION
A non-final Office action was mailed 26 February 2026 (“Office Action”).
Applicant’s reply to the Office Action was received 18 May 2026 (“Reply”).
Status of the Claims
The listing of claims filed with the Reply has been examined.
New claims 41–60 are pending.
Claims 1–40 are canceled.
Status of Rejections and Objections
The text of those sections of Title 35, U.S. Code and/or text providing the basis for non-statutory double patenting rejections not included in this action are set forth in the Office Action.
Unless repeated herein, any objection or rejection in the Office Action is withdrawn.
Examiner acknowledges the approval of an electronic terminal disclaimer (TD) filed with the Reply. The TD covers U.S. Pat. Nos. 11,779,559 and 11,382,885.
Objections to the Abstract
The abstract of the disclosure is objected to because it recites phrases that can be implied (“The disclosure provides”) and legal phraseology (“comprising”).
Appropriate correction is required.
For guidelines for the preparation of patent abstracts, see MPEP § 608.01(b) (Explaining: The abstract should be in narrative form and avoid legal phraseology (e.g., means, said), terms referring to purported merits of the invention (e.g., new, novel), and phrases that can be implied (e.g., The disclosure concerns, The disclosure defined by this invention). The language should be clear and concise, and not repeat information given in the title. It should not compare the invention with the prior art. The abstract is generally limited to a single paragraph within the range of 50 to 150 words in length.).
Reply to Arguments
Applicant did not address the objection to the abstract in the Reply.
Claim Rejections - 35 U.S.C. § 103
Claims 57–60 are rejected under 35 U.S.C. § 103 as being unpatentable over US 2015/0126571 (“Bryan”) [IDS] as evidenced by Aminosyn 10% label in view of WO 2015/038339 (“Hancock”).
The Graham factors are addressed in turn below.
Determining the scope and contents of the prior art
Bryan discloses a method of treating a bacterial infection, comprising administering a composition comprising Aminosyn 10% and L-cysteine. (Bryan, ¶¶7, 13). Aminosyn 10% contains aspartic acid and glutamic acid. (Id., ¶13).
The L-cysteine was added to the solution of Aminosyn 10% for testing. (Id.).
Thus, Bryan discloses a method of administering a composition comprising aspartic acid, glutamic acid, and L-cysteine to treat a bacterial infection.
Bryan discloses liquid solution compositions such as oral, intravenous, and topical administrations, as well as nasal irrigation. (Id., ¶¶10,22–24; claims 3, 4, 7, 9, 12, 14).
Regarding the concentrations in claims 23, 24, 32, and 33, Aminosyn 10% label discloses 700 mg of L-aspartic acid and 738 mg of L-glutamic acid per 100 mL. These values are encompassed by the claimed ranges that include “about 5.0% (w/v).”
Hancock discloses a peptide composition for inhibiting the growth of a biofilm. (Hancock, ¶¶1, 118). Hancock discloses a method of administering the composition for inhibiting the growth of a microbe. (Id., ¶17).
Hancock states the microbe can be Staphylococcus aureus, Staphylococcus epidermidis, and Enterococcus faecalis, and that each are Gram-positive bacterium. (Id., ¶17, “the microbe can be a Gram positive bacterium, such as Staphylococcus aureus, Staphylococcus epidermidis, or Enterococcus faecalis.”); (Id., claim 11, “wherein the bacteria is Staphylococcus aureus, Staphylococcus epidermidis, or Enterococcus faecalis.”).
Ascertaining the differences between the prior art and the claims at issue
Bryan does not disclose a method of treating a biofilm or bacterial infection caused by Enterococcus faecalis, Rothia dentocariosa, Streptococcus, or Stomatoccus mucilaginosus.
There may be differences between the concentrations of the components in Bryan and the claimed components in claim 58 (e.g., about 0.1% to about 1% (w/v)).
Resolving the level of ordinary skill in the pertinent art
The level of one of ordinary skill may be found by inquiring into: (i) the type of problems encountered in the art; (ii) prior art solutions to those problems; (iii) the rapidity with which innovations are made; (iv) the sophistication of the technology; and (v) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of the factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983). Based on the typically high education level of workers in the pharmaceutical art and the high degree of sophistication required to solve problems encountered in the art, Examiner finds a person having ordinary skill in the art would have at least a college degree in chemistry, biology, biochemistry, pharmacology, or a related field, and several years of experience.
Considering objective evidence present in the application indicating obviousness or nonobviousness
The instant application does not include data related to treating a biofilm or bacterial infection cause by Enterococcus faecalis, Rothia dentocariosa, Streptococcus, or Stomatoccus mucilaginosus. The examples that discuss testing the compositions against one or more of the bacteria are prophetic and do not refer to data.
The instant application includes data related to the concentration of the claimed components in the context of biofilm inhibition. (Spec., pp.83–84). The specification states: “At concentrations lower than 0.5% of each amino acid in combination, the biofilm inhibition and disruption rates are less effective. At concentrations above 0.5%, there is no increase in effectiveness against biofilms.” (Id., p.83).
The question of obviousness
Based on the above factors, it would have been prima facie obvious for a person having ordinary skill in the art prior to the filing of the instant application to modify Bryan and/or to combine the teachings of Bryan and Hancock because the references are directed to subject matter in a related field (i.e., the treatment of bacterial infection). One of ordinary skill in the art would have been motivated to combine the teachings of the cited references to provide an additional treatment for drug resistant bacteria. Because the claimed method is generally disclosed in Bryan for the treatment of Staphylococcus aureus, and Hancock discloses Staphylococcus aureus, Staphylococcus epidermidis, and Enterococcus faecalis are each a Gram positive bacterium that can be treated with the same composition, as evidenced by their grouping together in the specification and claim, a person having ordinary skill in the art prior to the filing of the instant application would have been a reasonable expectation of success at arriving at the claimed invention because the method of administering is taught in Bryan and the modification is directed to other common Gram positive bacterium (Staphylococcus epidermidis and Enterococcus faecalis). Further, any differences between the concentrations in the cited references and the concentrations of the claimed components would not necessarily affect the result of the claimed method, as the instant specification establishes only a minimum concentration of 0.5% is required for appropriate biofilm inhibition and disruption rates.
Reply to Arguments
Regarding the anticipation rejection of now canceled claims 21–30 and 32–35, Applicant quotes Bryan ¶¶13 and 14 and concludes Bryan is not enabled. (Remarks, p.7). Applicant does not provide an analysis relevant to enablement or explain what Bryan is not enabled for. (Id.). For example, Applicant does not argue that one of ordinary skill in the art would not be able to make or use the compositions in Bryan to treat a biofilm. To the contrary, Bryan discloses how to make and use related compositions to treat a biofilm. Accordingly, Applicant’s argument has been fully considered and it is not persuasive. To be clear, the anticipation rejection has been withdrawn because claims 21–30 and 32–35 are canceled and the rejection has not been applied to new claims 41–56 because claim 41 excludes components present in Aminosyn 10%.
Regarding the obviousness rejection of now canceled claims 31 and 36–39, Applicant argues Bryan teaches away from the composition recited in the claimed method. (Id., p.8 (quoting Bryan ¶¶13, 14)). The obviousness rejection above is applied to new claims 57–60. The composition recited in the claimed method comprises three components: cysteine, glutamic acid, and aspartic acid. The composition discussed in Bryan comprises four components: Bryan adds cysteine to Aminosyn 10%, which contains tyrosine, aspartic acid and glutamic acid. (Bryan, ¶¶7, 13). Bryan states: “This may indicate that tyrosine, aspartic acid, or glutamic acid may inhibit the destructive effect of one or some of the other amino acids on the bacterial biofilm.” (Id., ¶13). Thus, the lack of destructive effect on a biofilm discussed in Bryan is discussing a composition with four components. Because the claimed composition and the composition in Bryan are not the same, Bryan does not teach away from the claimed composition. Accordingly, Applicant’s argument has been fully considered and it is not persuasive.
Conclusion
Claims 41-56 are allowed.
Claims 57–60 are rejected.
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 C.F.R. § 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 C.F.R. § 1.17(a)) pursuant to 37 C.F.R. § 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.
Communication
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/J.M.N./Patent Examiner, Art Unit 1623
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
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