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
Filing Receipt and Priority
The filing receipt mailed 03/29/2024 states that the instant application is a 371 of PCT/EP2021/083523, filed 11/30/2021.
The filing receipt also states that instant application claims benefit of foreign application UK 2018840.5, filled 11/30/2020. The foreign document supports the instant claims. Therefore the effective filing date is 11/30/2020.
Information Disclosure Statement
The information disclosure statements submitted 05/26/2023, 09/21/2023, and 05/29/2026 have been considered.
Restriction/Species Election
Applicant’s election of Group I, claims 1-9 and 11 is acknowledged.
Applicant’s election of K. pneumoniae is also acknowledged.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 13-17, and 19-24 are withdrawn being drawn to a non-elected invention.
Claim Objection
Claim 1 uses the term “DHA”. The specification teaches that “DHA” is “docosahexaenoic acid”. Within the claims, it is proper to, on first recitation, to use the full word which the abbreviation stands for. Examiner recommends amending claim 1 to at least state “docosahexaenoic acid (DHA)”.
Claim 2 states “wherein the [non-living] surface is the surface of a surgical instrument, [the surface of] a medical device, a surface in a clinical setting, a surface in a bioprocessing facility, or the surface in a food processing facility.” This is inconsistent use of “a” and “the”. Typically, “the” is used after the first instance. “A” is reserved for first instances. Claim 2 should be amended to state “wherein the [non-living] surface is a surface of a surgical instrument, [a surface of] a medical device, a surface in a clinical setting, a surface in a bioprocessing facility, or a surface in a food processing facility.”
Correction is required.
Claim 11 does not italicize Klebsiella pneumoniae.
Claim 11 is missing a period at the end.
Rejections
Claim Rejections - 35 USC § 112(a)
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 1-9 and 11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for specific concentrations of DHA, does not reasonably provide enablement for all concentrations of DHA. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The following Wands Factors have been considered if not explicitly stated: (A) The breadth of the claims, (B) The nature of the invention, (C) The state of the prior art, (D) The level of one of ordinary skill, (E) The level of predictability in the art, (F) The amount of direction provided by the inventor, (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Breadth of the claims
Claim 1 is drawn to a method for preventing biofilm formation on a non-living surface via administration of docosahexaenoic acid (DHA). Applicant has elected Klebsiella pneumoniae.
Currently only claim 9 specifies concentrations. Claim 1 claims administration of any amount of DHA.
Nature of the invention
The invention is a method for sanitization and preventative of bacterial infection.
State of the prior art
Docosahexaenoic acid’s ability to disrupt biofilms is discussed in Kumar (Trends in Microbiology, Sept. 2020, Vol. 28, No. 9). Kumar on p. 753 states “Recent studies suggest that fatty acids (FAs) hold great potential, since several FAs have been identified to selectively inhibit or disrupt biofilm formation by various microbial pathogens…”. Kumar on p. 756, Table 1 indicates that DHA was over 90% and 55% effective in reducing biofilms of P. gingivalis and S. aureus respectively. This is further discussed in Verderosa (Frontiers in Chemistry, 2019, Vol. 7, Art. 824). Verderosa states “Shu et al. recently explored the biofilm eradication capabilities of the two fatty acids, docosahexaenoic acid and eicosapentaenoic acid against Porphyromonas gingivalis and Fusobacterium nucleatum biofilms. Administration of docosahexaenoic acid or eicosapentaenoic acid (100 μM) to mature P. gingivalis biofilms eradicated a significant proportion of the live cell population (61 and 47% respectively). The same effect was also evident, albeit to a lower degree, for F. nucleatum biofilms (19 and 31%, respectively). In a follow-up publication by the same group, these same two fatty acids were assessed for activity against Streptococcus mutans biofilms. Both docosahexaenoic acid and eicosapentaenoic acid were found to significantly damaged the outer membrane of biofilm residing cells (58.8 and 62.5%, respectively), and consequently reduced biofilm thickness by 19 and 242%, respectively, in S. mutans.”
A more general discussion of fatty acids as antimicrobials is found in Desbois (Recent Patents on Anti-Infective Drug Discovery, 2012, 7, 111-122). Desbois on p. 16, left col., para 1 states “…Richter and Reinhardt demonstrated the effectiveness of a topical composition containing 17.5 g/L heptanoic (C7:0) acid against eight mastitis-causing microorganisms in vitro. In a milieu containing 10% milk, the C7:0 composition reduced inoculums of Enterobacter aerogenes, E. coli, Klebsiella pneumoniae,…”.
Additionally, Sharma (Can. J. Microbiol. 59:503-510, 2013) discusses the effects of administering fish oil, which contains docosahexaenoic acid, on mice with K. pneumoniae related pneumonia.
The art at least supports that one of ordinary skill would look to docosahexaenoic acid as a potential compound to counter biofilm formation, however this is directly contradicted by Hobby (MicrobiologyOpen, 2019;8:e635, of the record). Hobby in sec. 3.7 states “…arachidonic acid (20:4) and docosahexaenoic acid (22:6) led to increased biofilm formation.” This is a direct teaching away and, in view of Hobby, one of ordinary skill would not use docosahexaenoic acid to prevent K. pneumoniae biofilm formation.
Existing of working examples and direction provided
The instant specification, in figures 1A, 2, and 3 gives concentrations of DHA that are effective in reducing biofilm formation. Figure 1A, shown below, is discussed by the instant specification. The specification states that figure 1 shows “the effect of varying concentrations of DHA on the ability of Klebsiella pneumoniae NCIMB 418…to form biofilm in vitro.”
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Greyscale
The figure above shows efficacy for concentrations ranging from 6 to 100 μM. Regarding claim 9, which claims concentrations ranging from 100 μM to 1000 μM and 6 μM to 500 μM (see 112(b) rejection below), applicant only has support for 6 – 500 μM.
Applicant is enabled for administering 6 to 500 μM to prevent biofilm formation of K. pneumoniae. Applicant has not shown efficacy for concentrations exceeding this amount or below this amount.
Quantity of experimentation
Considering the amount of direction and the direct teaching away in Hobby, there is a significant level of unpredictability should one of ordinary skill attempt to practice the claimed method outside of the concentration range of 6 to 500 μM. Therefore, there is an undue burden of experimentation placed upon one of ordinary skill in the art to determine which concentrations of DHA prevent K. pneumoniae biofilm formation.
Claim Rejections - 35 USC § 112(b)
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 1-9 and 11 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.
Indefinite Term – “Derivative”
Claim 1 uses the term “derivative”. The term “derivative” is not explicitly defined. The specification on p. 5-6 states “A derivative is a compound that is derive[d] from DHA but differs by a structural modification, for example replacement f one atom or a group of atoms or a functional group with another atom or group of atoms or a functional group. It is a ‘functional derivative” in that [it] has the same function, e.g. can treat or prevent a biofilm in a subject.” This discussion is non-limiting and non-exhaustive. While this paragraph contemplates modification of functional groups or atoms, it does not clearly lay out whether esters, amides, acyl halides, are included. Additionally, it is not clear if the product of ozonolysis on DHA, or similar cleavage reaction, is included in the term “derivative”.
As claims 2-9 and 11 are dependent on claim 1, they are also rejected.
Conflicting Claim Language
Claim 11 states “The method of Claim 1, wherein the biofilm comprises Klebsiella pneumoniae, or consists of Klebsiella pneumoniae”. “Comprises” is open-ended language. “Consists” is closed language. The use of both within the claim is indefinite as they contradict each other.
Claim 4 states “wherein the surface is an interior surface and/or exterior surface.” The claim includes situations where non-living surface is either an interior surface or an exterior surface. It also includes an embodiment wherein the surface is both an exterior surface and an interior surface. It is not clear how a single surface can be both interior and exterior simultaneously. Using “or” is sufficient.
Antecedent Basis
Claims 1, 2, 4, 5, 7 state “surface” where they should state “non-living surface”. The first instance of “surface” is “non-living surface”. Claim 1 then simply repeats “surface” in l. 3 of said claim. Claims 2, 4, 5, and 7 also state “surface”. To be consistent with the first instance of “surface”, the claims should state “non-living surface”.
Note: Claim 2 states “…the surface of a surgical instrument, [the surface of] a medical device, a surface in a clinical setting, a surface in a bioprocessing facility, or the surface in a food processing facility.” “Non-living” is not required before each instance of “surface” after “wherein the [non-living] surface” in l. 1 of claim 2. As an example, claim 4, which states “wherein the [non-living] surface is an interior surface and/or exterior surface”, is appropriate.
Broad range followed by narrow range
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation “100μM to 1000μM”, and the claim also recites “6μM to 500μM” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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/LUISALBERTO GONZALEZ/Examiner, Art Unit 1624
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