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
Disposition of Claims
Claims 18-28 are pending. The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not). Note that in the instant claim set, there are two claim “22”s.
The second misnumbered claim 22 has been renumbered 23, and all subsequent claims following have been renumbered for the purpose of examination. The claim numbering and claim pendency should be updated in response to this Office action.
Examiner’s Note
All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US20240318224A1, Published 09/26/2024.
Applicant is encouraged to utilize the new web-based Automated Interview Request (AIR) tool for submitting interview requests; more information can be found at https://www.uspto.gov/patent/laws-and-regulations/interview-practice.
Optional Authorization to Initiate Electronic Communications
The written authorization from Applicant’s representative to correspond with the Examiner via electronic mail (e-mail) dated 01/16/2024 is acknowledged and entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/16/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Notably, the disclosure statement filed lists a Search Report. The listing of the references cited in a Search Report itself is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the Search Report have not been considered. Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the Search Report are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See “References” at ¶[0066]: “www.sciencedirect.com/science/article/abs/pii/S0022283605803602” ; “www.ncbi.nlm.nih.gov/pmc/articles/PMC5210524/9” ; “www.ncbi.nlm.nih.gov/pmc/articles/PMC2265698/10” ; and ¶[0054] “www.bioinformatics.babraham.ac.uk/projects/fastqc” .
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered “second” claim 22 has been renumbered 23, and all subsequent claims following have been renumbered.
Claim Rejections - 35 USC § 112(b); Second 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 19, 23, and 27, and dependent claims 20, 24, and 28 thereof 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.
Claims 19, 23, and 27 recite the limitation of “wherein the composition causes lysis” but fails to identify what is being lysed. The limitation does not specify whether the lysis is of Pseudomonas aeruginosa, a particular Pseudomonas aeruginosa strain, another bacterial cell/population, a biofilm, a different type of cell, or another target. Because phage-mediated lysis is dependent on host identity, strain susceptibility, growth state, and assay conditions, one of ordinary skill in the art would not be reasonably apprised of the scope of the claimed composition without identification of the specific target that is being lysed.
Additionally, claims 19, 23, and 27 use the definite article “the” before “phage-phage synergy, phage-antibiotic synergy and/or biofilm activity”, but nowhere previously within that same claim, nor elsewhere in the claim upon which the claim depends is “phage-phage synergy, phage-antibiotic synergy and/or biofilm activity” ever recited, making the antecedent basis unclear. Further, the claims fail to clearly indicate whether the claimed composition is required to exhibit phage-phage synergy, phage-antibiotic synergy, and/or biofilm activity, or whether such properties are merely capable of being measured if present. The phrase “biofilm activity” is also unclear because the claim does not specify whether the “activity” refers to lysis of biofilm-associated bacteria, inhibition of biofilm formation, disruption of an established biofilm, reduction in biofilm biomass, or another related property to said biofilm.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claims 19, 23, and 27 are rejected on the grounds of being indefinite. Claims 20, 24, and 28 are also rejected since they depend from claims 19, 23, or 27, but do not remedy these deficiencies of claims 19, 23, or 27.
Claims 20, 24, and 28 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.
Claim 20 is drawn to “the composition of claim 19, wherein the change in photometry is measured using an additive that causes and/or enhances the photometric signal detection, which additive is optionally tetrazolium dye.” However, the use of the phrase “which additive” appears to refer to the previously recited “an additive”, but the limitation is unclear because “optionally tetrazolium dye” does not clearly indicate whether the tetrazolium dye is required as a part of the claim composition or method of measurement. If the tetrazolium dye is merely optional, the phrase does not appear to further limit the claim. Accordingly, the scope of the claim is unclear.
One suggestion is to amend the claim along the lines of the following: “20. The composition of claim 19, wherein the change in photometry is measured using an additive that causes and/or enhances the photometric signal detection, wherein the additive is tetrazolium dye.”
Claims 24 and 28 are also rejected for similar reasoning.
For at least these reasons, the metes and bounds of claims 20, 24, and 28 are unclear.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. In light of the claim numbering issues, the claims are interpreted as being drawn to the following with the following numbering and pendency:
Claim 18 is drawn to a composition comprising at least three phages selected from EPa8, EPa9, Epa15, EPa82, EPa83, and EPa87.
19. The composition of claim 18, wherein the composition causes lysis as measured by a change in growth inhibition, optical density, metabolic output, photometry, and/or plaque formation, wherein the phage-phage synergy, phage-antibiotic synergy and/or biofilm activity is measured in a lysis assay.
20. The composition of claim 19, wherein the change in photometry is measured using an additive that causes and/or enhances the photometric signal detection, which additive is optionally tetrazolium dye.
Claim 21 is drawn to a composition comprising the phages EPa83 and EPa87, and at least one phage selected from EPa1 EPa2, EPa4, EPa5, EPa6, EPa7, EPa10, EPa11, EPa12, EPa13, EPa14, EPa16, EPa17, EPa18, EPa20, EPa21, EPa22, EPa24, EPa25, EPa26, EPa33, EPa38, EPa39, EPa40, EPa41, and EPa43.
22. The composition of claim 21, wherein the composition consists of the phages EPa83, EPa87, EPa11, and EPa39.
23. The composition of claim 22, wherein the composition causes lysis as measured by a change in Growth inhibition, Optical density, Metabolic output, Photometry, and/or Plaque formation, wherein the phage-phage synergy, phage-antibiotic synergy and/or biofilm activity is measured in a lysis assay.
24. The composition of claim 23, wherein the change in photometry is measured using an additive that causes and/or enhances the photometric signal detection, which additive is optionally tetrazolium dye.
Claim 25 is drawn to a composition comprising the phage EPa15 and at least one phage selected from EPa1 EPa2, EPa4, EPa5, EPa6, EPa7, EPa10, EPa11, EPa12, EPa13, EPa14, EPa16, EPa17, EPa18, EPa20, EPa21, EPa22, EPa24, EPa25, EPa26, EPa33, EPa38, EPa39, EPa40, EPa41, and EPa43.
26. The composition of claim 25, which consists of EPa15, EPa11, EPa16, EPa18, EPa22 and EPa43.
27. The composition of claim 25, wherein the composition causes lysis as measured by a change in Growth inhibition, Optical density, Metabolic output, Photometry, and/or Plaque formation, wherein phage-phage synergy, phage-antibiotic synergy and/or biofilm activity is measured in a lysis assay.
28. The composition of claim 27, wherein the change in photometry is measured using an additive that causes and/or enhances the photometric signal detection, which additive is optionally tetrazolium dye.
Claim Rejections - 35 USC § 112(a); First 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 19-20, 23-24, and 27-28 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.
The following quotation from section 2163 of the Manual of Patent Examination Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirements for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice .... reduction to drawings .... or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
Claims 19-20, 23-24, and 27-28 are rejected as lacking adequate descriptive support for any combination of the EPa phage combinations which are capable of performing the claimed functions of lysis of any biomaterial, wherein said lysis is measured by a change in growth inhibition, optical density, metabolic output, photometry, and/or plaque formation.
In support of the claimed genus (EPa phage combinations which perform any lysis of any biomaterial), the application discloses examples in which three phage cocktails PAM2, PAM3, and PAM-CF1 were generated (Tables 4-5) and also exhibits the ability to lyse Pseudomonas aeruginosa isolates from mucoid pulmonary or “cystic fibrosis” samples (it is not clear from the specification whether the “cystic fibrosis” samples were also from pulmonary mucus or from other samples obtained from a patient or animal model with cystic fibrosis)(¶[0065-0066]). Claim 18 has 42 possible combinations of phage while claims 21 and 25 have 6.7x10^7 possible combinations of phage, and while the large number of possible combinations of phage in a composition is not necessarily a written description issue, the breadth of functional characteristics tied to the compositions becomes an issue as only three specific phage cocktails were generated. No other phage combinations are disclosed that can achieve any of the claimed functional characteristics, so it is unclear if all possible combinations would act in synergy, would have no effect, or if said combinations would possibly interfere with normal phage activity. Thus, the application fails to provide examples of a sufficient number of species within the claimed genus.
Furthermore, while the application and claims describe how the functional parameters may be tested, this does not provide written description of those phage cocktails which perform said functional parameters. The specification fails to provide common structural/functional features of said cocktails sufficient to show that applicant was in possession of the full scope of the multi-phage compositions of claims 18, 21, and 25 which displayed the functional characteristics as outlined in claims 19, 23, and 27. Simply describing how to measure lysis, synergy, or biofilm activity does not establish possession of all claimed phage combinations that achieve the recited functional outcome. Furthermore, the functional outcome is dependent on other variable parameters, such as the bacterial strain tested, host-range specificity of each phage, dose/MOI of each phage in the cocktail, culture conditions, biofilm state, antibiotic used, and interactions amongst the phage within the cocktail. The specification does not provide sufficient data or other identifying characteristics showing that each claimed three or more phage combination causes the recited lysis in all possible bacteria or possess the recited synergy or biofilm activity.
Thus, in view of the above, there would have been significant uncertainty as to which phage combinations/cocktails would be able confer the claimed functions of lysis, synergy, or biofilm activity. In view of this uncertainty and the lack of sufficient examples of the claimed genus, the claims are rejected for lack of adequate written description support.
Claims 19-20, 23-24, and 27-28 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 phage cocktails PAM2, PAM3, and PAM-CF1, does not reasonably provide enablement for any of the EPa phage cocktails claimed with the functional limitations claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The legal considerations that govern enablement determinations pertaining to undue experimentation have been clearly set forth. Enzo Biochem, Inc., 52 U.S.P.Q.2d 1129 (C.A.F.C. 1999). In re Wands, 8 U.S.P.Q.2d 1400 (C.A.F.C. 1988). See also MPEP § 2164.01(a) and § 2164.04. Ex parte Forman 230 U.S.P.Q. 546 (PTO Bd. Pat. App. Int., 1986). The courts concluded that several factual inquiries should be considered when making such assessments including: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art and the breadth of the claims. In re Rainer, 52 C.C.P.A. 1593, 347 F.2d 574, 146 U.S.P.Q. 218 (1965). The disclosure fails to provide adequate guidance pertaining to a number of these considerations as follows:
Nature of the invention/Breadth of the claims. The claims are broadly drawn to numerous distinct multi-phage compositions and further require that the compositions satisfy the functional limitations of claims 19, 23, and 27. As set forth supra, these claims depend upon claims 18, 21, and 235, and these claims have anywhere from 42 possible combinations of phage up to 6.7x10^7 possible combinations of phage. The claims are not limited to only the identity/presence of the phages in the composition/cocktail, but specific functional qualities, namely that the cocktail of phage cause lysis as measured by changes in growth inhibition, optical density, metabolic output, photometry, and/or plaque formation, and further recite phage-phage synergy, phage-antibiotic synergy, and/or biofilm activity measured in a lysis assay. These limitations are being interpreted broadly in light of the 35 USC 112b rejections supra.
The breadth of these limitations raises a question of enablement because the functional limitations are not inherent to every possible phage combination merely because the individual phages are named or their entire genomic sequence has been provided. Whether a given phage cocktail causes lysis, exhibits phage-phage synergy, exhibits phage-antibiotic synergy, or has biofilm activity depends on the particular phage combination, the bacterial strain tested, the relative amount of each phage, multiplicity of infection, bacterial growth state, biofilm state, antibiotic identity and concentration, assay conditions, and resistance mechanisms. The claims are not limited to a small number of possible cocktails which have been tested to define assay conditions which would confine the functional scope to embodiments actually shown to work.
State of the prior art/Predictability of the art. The state of the prior art supports the conclusion that the functional limitations of the claims were unpredictable and could only be empirically determined at the time of filing.
Chaudhry et. al. (Chaudhry WN, et. al. PLoS One. 2017 Jan 11;12(1):e0168615.) teaches that combinations of two phages and bactericidal antibiotics were evaluated against P. aeruginosa biofilms, and that some phage-drug combinations produced synergy while others did not, even if said antibiotics were in the same drug class. Chaudhry also taught that there was an order effect in some cocktails in that treatment with phage before antibiotic treatment achieved maximum killing. Tagliaferri et. al. (Tagliaferri TL, et. al. Front Cell Infect Microbiol. 2019 Feb 18;9:22.) notes that in some instances, the combination of phage and antibiotics shows negative interference between phages and antibiotics, while some combinations showed little to no strength in reduction of bacteria or biofilm, and that phage could be hindered early in treatment, but then show adaptation to replication and treatment at later days during treatment (e.g. a week or longer). Gu Liu et. al. (Gu Liu C, et. al. mBio. 2020 Aug 4;11(4):e01462-20.) teaches that phage-antibiotic interactions include synergism, additivism, and antagonism, and that such interactions are highly dependent on antibiotic mechanisms of action and stoichiometry. Liu teaches that host conditions simulating infection environments can suppress phage-antibiotic synergy in a bacterial growth-dependent manner, and that related phages having different burst sizes can produce different interaction profiles. These references all support that phage-antibiotic synergy cannot be reliably predicted from the mere identity of a phage or antibiotic.
The art has also recognized that not all phage work in the same way on the same type of bacteria, and that resistance can arise to singular phage or cocktails of phage. Yang et. al. (Yang Y, et. al. Front Microbiol. 2020 Mar 4;11:327.) teaches formulation of a five-phage P. aeruginosa cocktail and testing across a panel of 23 P. aeruginosa strains. Yang teaches that each phage had a distinct host range and that no individual phage lysed all strains tested in the panel. Additionally, Yang noted that the cocktail had broader host range than individual phages, but that P. aeruginosa resistance to the cocktail still emerged after extended incubation. Yang highlights that there is uncertainty in phage host range and lysis, and that outcomes are composition and strain dependent and require empirical testing for confirmation.
With respect to cocktails of phage, the art has also recognized that rational design of cocktails still requires empirical testing to ensure the validity of the compositions. For instance, Forti et. al. (Forti F, et. al. Antimicrob Agents Chemother. 2018 May 25;62(6):e02573-17.) notes that a rational design of a six-phage P. aeruginosa cocktail using host range and genomic information, and describes testing the cocktail against clinical strains of P. aeruginosa and biofilm models. Forti notes the importance of testing preferably the in vivo activity of the cocktails over in vitro testing to a particular patient strain before implementation of the cocktail in the patient, and that the mechanisms behind whether or not cocktails act in a synergistic fashion or not need are still unknown.
Accordingly, the prior art shows the claimed functional outcomes in relation to the claimed phage cocktails is not predictable and is highly context-dependent, requiring empirical testing to ensure said compositions act in concert with one another. The prior art does not support that all phage would possess one or more of the claimed functional outcomes, and one of ordinary skill would not be able to predict, from genomic sequence alone, which phage combinations would cause lysis or any of the other functional outcomes presently claimed.
Working examples. The working example disclosed in the specification focused on three phage cocktails, namely PAM2 (EPa11, EPa17, EPa22, EPa24, EPa43), PAM3 (EPa11, EPa16, EPa17, EPa18, EPa22, EPa39, EPa43), and PAM-CF1 (EPa11, EPa82, EPa83, EPa87). PAM1 and PAM2 showed efficacy against lethal septicemic and local dorsal wound infections in mice while also displaying stability, full activity and resistance reduction when used as pairwise mixes (¶[0066]; Tables 4-5). The 4-phagecocktail, PAM-CF1, consisting of one wild phage and three host range mutants was unexpectedly and surprisingly active against 40/47 (85%) of cystic fibrosis isolates (¶[0065]). These limited examples are not commensurate in scope with the breadth of possible phage cocktails, and while the specification notes that the cocktails were employed in accordance with the invention, including anti-biofilm effects, identification of host receptors, testing phage stability and activity in mixes, and in vivo studies, in addition to identification of six different receptors for P. aeruginosa phages in different parts of LPS and type IV pilus, no specific rationale or guidance was provided to a skilled artisan to exemplify how to rationally combine these phage. The claims encompass a large amount of possible combinations, and the specification does not show how those phage in those combinations would reliably or predictably harbor the claimed functional aspects.
Guidance in the specification. The specification provides guidance towards the three specific phage compositions, namely PAM2, PAM3, and PAM-CF1, and how to test whether or not a phage cocktail lyses a bacterial population through measurement in changes in growth inhibition, optical density, metabolic output, photometry, and/or plaque formation, and that phage-phage or phage-antibiotic synergy and/or biofilm activity may be measured in a lysis assay. However, the specification does not provide sufficient direction for determining which of the claimed phage combinations will satisfy the claimed functional limitations. The specification fails to provide predictive criteria correlating phage genomic sequences, host range, receptor usage, or other structural features with the claimed functional outcomes. The specification fails to provide sufficient guidance as to which bacterial strains, antibiotics, phage ratios, phage multiplicity of infection (MOI), biofilm conditions, or assay thresholds are required to satisfy the claimed functional limitations.
Amount of experimentation necessary. Additional research is required in order to determine how effective the claimed phage compositions would be in performing the claimed functions, namely wherein the composition causes lysis as measured by a change in growth inhibition, optical density, metabolic output, photometry, and/or plaque formation, wherein the phage-phage synergy, phage-antibiotic synergy and/or biofilm activity is measured in a lysis assay.
In light of the Supreme Court decision in Amgen Inc. et al. v. Sanofi et al., 143 S. Ct. 1243 (2023) (hereafter Amgen), updated guidelines were provided regarding the assessment of enablement (Federal Register, pp. 1563-1566; Pub. Jan. 10, 2024.) In Amgen, the Supreme Court unanimously affirmed that a genus of monoclonal antibodies were not enabled because when a range within a genus is claimed, there must be reasonable enablement of the scope of the range. The Court found in Amgen that due to the large number of possible candidates within the scope of the claims and the specification's corresponding lack of structural guidance, it would have required undue experimentation to synthesize and screen each candidate to determine which compounds in the claimed class exhibited the claimed functionality. In the instantly claimed invention, the experimentation is not merely routine confirmation of predictable embodiments; the art has shown that there is great uncertainty in the functional outcomes of phage cocktails, and the vast number of possible phage combinations presently claimed would have to be empirically tested to ensure they possessed the claimed functions, making the experimentation required large and undue.
For the reasons discussed above, it would require undue experimentation for one skilled in the art to make and/or use the claimed phage compositions with the claimed functions.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claims 25 and 27-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Engeman et. al. (Engeman E, et. al. Pharmaceuticals (Basel). 2021 Feb 25;14(3):184.; CITED ART OF RECORD; hereafter “Engeman”.)
The Prior Art
Engeman teaches multidrug-resistant (MDR) Pseudomonas aeruginosa infections pose a serious health threat, and bacteriophage-antibiotic combination therapy is a promising candidate for combating these infections. Engeman teaches a 5-phage P. aeruginosa cocktail called PAM2H was tested in combination with the antibiotics ceftazidime (CAZ), ciprofloxacin, gentamicin, and meropenem to determine if PAM2H enhances antibiotic efficacy (entire document; see Abstract; Table 6.) The PAM2H cocktail comprised the following phage: EPa5, EPa11, EPa15, EPa22, and EPa43 (Table 6; instant claim 25).
In regards to claims 27-28, the recitation that “he composition causes lysis as measured by a change in growth inhibition, optical density, metabolic output, photometry, and/or plaque formation, wherein phage-phage synergy, phage-antibiotic synergy and/or biofilm activity is measured in a lysis assay” and “wherein the change in photometry is measured using an additive that causes and/or enhances the photometric signal detection, wherein the additive is tetrazolium dye” are not positive limitations but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchison, 69 USPQ 138 (CCPA 1946); In re Swinehart, 169 USPQ 226 (CCPA 1971); and In re Schreiber, 44 USPQ2d 1429 (Fed. Cir. 1997). A patent applicant is free to recite features of an apparatus either structurally or functionally. See In re Swinehart, 439 F.2d 210, 212, 169 USPQ 226, 228 (CCPA 1971) (“ [T]here is nothing intrinsically wrong with [defining something by what it does rather than what it is] in drafting patent claims.”). Yet, choosing to define an element functionally, i.e., by what it does, carries with it a risk. As our predecessor court stated in In re Swinehart, 439 F.2d at 213, 169 USPQ at 228:
where the Patent Office has reason to believe that a functional limitation asserted to be critical for establishing novelty in the claimed subject matter may, in fact, be an inherent characteristic of the prior art, it possesses the authority to require the applicant to prove that the subject matter shown to be in the prior art does not possess the characteristic relied on
Therefore, the functional features of claims 27-28 would be an inherent characteristic of the phage cocktails of Engeman since the phage cocktails of Engeman meets all the structural limitations of the claimed phage compositions.
For at least these reasons, Engeman teaches the limitations of instant claims 25 and 27-28, and anticipates the invention encompassed by said claims.
Allowable Subject Matter
Claims 18 and 21-22 are allowed.
Claim 26 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the phage present in instant independent claim 18, represented by SEQ ID NOs: 7-8, 14, and 30-32, appear to be novel and nonobvious.
Conclusion
Claims 18 and 21-22 are allowed. Claims 19-20, 23-25, and 27-28 are rejected.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and is listed below.
Fu W, et. al. Antimicrob Agents Chemother. 2010 Jan;54(1):397-404. Epub 2009 Oct 12. Teaches use of bacteriophage cocktail to treat P. aeruginosa in an in vitro system. Does not appear to teach the specific phage of the instant claims.
US20120177608A1. Teaches use of bacteriophage to treat P. aeruginosa. Does not appear to teach the specific phage of the instant claims.
US20170319637A1. Teaches use of bacteriophage to treat P. aeruginosa. Does not appear to teach the specific phage of the instant claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL B GILL whose telephone number is (571)272-3129. The examiner can normally be reached on M to F 8:00 AM to 5:00 PM Eastern.
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/RACHEL B GILL/
Primary Examiner, Art Unit 1671
Prosecution Insights