DETAILED ACTION
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 .
Election/Restrictions
1. Applicant’s election without traverse of Group I, encompassing claims 1-14 and 34-36, in the reply filed on April 30, 2026, is acknowledged.
2. Claims 15-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 30, 2026.
3. Accordingly, claims 1-14 and 34-36 are under examination in the current office action.
Information Disclosure Statement
4. The information disclosure statements (IDSs) filed 08/17/2021, 06/17/2022, 03/21/2023 have been considered and the references therein are of record.
Claim Rejections - 35 USC § 112
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.
5. Claims 10-11 and 13-14 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 10 is indefinite because it recites dependency from itself (i.e., “The method of claim 10…”) The metes and bounds of the claim therefore cannot be readily determined.
Claims 11 and 13-14 are included in this rejection because they each depend, directly or indirectly, from indefinite claim 10.
Claim Rejections - 35 USC § 102
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.
6. Claim(s) 1-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Balczon et al. (FASEB J. (2017 Jul) 31:2785-2796) (listed on 06/17/2022 IDS).
Balczon et al. teach a method that comprises growing pulmonary microvascular endothelial cells (PMVECs) to confluence in culture (mammalian cell in cell culture media (claim 1a); the mammalian cell is an endothelial cell (claim 2); the mammalian cell is a PMVEC (claim 3)), infecting the cells with a strain of bacteria (contacting a mammalian cell in cell culture media with an infectious agent (claim 1a)) at a multiplicity of infection of 20:1 for either 2.5 or 4 hours (incubating the cell culture admixture for an amount of time sufficient to induce the production and release of an antimicrobial amyloid protein complex into the cell culture media (claim 1b); wherein step (b) comprises incubating for an initial period that is about four hours (claim 8)), and then collecting culture supernatants (harvesting the cell culture media that harbors the antimicrobial amyloid protein complex (claim 1c)). The culture supernatants were centrifuged to remove debris and filter sterilized (further comprising step (d) filter-sterilizing the cell culture (claim 9)). See first paragraph under “Cytotoxicity assay” at p. 2786 for these method steps taught by Balczon.
Regarding claims 1(a) and 4-7, Balczon teaches that the PMVECs were infected with a DPcrV strain of Pseudomonas aeruginosa, which strain is taught to be incapable of transferring exotoxins to target cells as the PopB/D channel is not formed (see “Bacterial strains” at p. 2786). Balczon teaches that the DPcrV strain of P. aeruginosa lacks the functional type III secretion system and is incapable of injecting exoenzymes into host cells (see p. 2788, right col., 2nd paragraph). See also Fig. 1A, which demonstrates that naïve PMVECs contacted with supernatant collected from PMVECs that had been inoculated with DPcrV bacteria lacked cytotoxic activity (the cell culture comprising the antimicrobial amyloid protein complex is non-cytotoxic (claim 7)).
The court in Integra Life Sciences I Ltd. v. Merck KGaA, 50 USPQ2d 1846 (DC SCalif, 1999) held that a reference teaching a process may anticipate claims drawn to a method comprising the same process steps, despite the recitation of a different intended use in the preamble or the later discovery of a particular property of one of the starting materials or end products. In the instant case, Balczon teaches a method that comprises the same steps (a), (b) and (c) as in present claim 1, and therefore has inherently performed a method for producing and harvesting an antimicrobial amyloid protein composition as claimed.
Regarding the “thereby” clause recited in claim 1 (“thereby producing and harvesting an antimicrobial amyloid protein composition”), the clause does not recite any additional active method steps, but simply states a characterization or conclusion of the results of those steps. Therefore, the “thereby” clause is not considered to further limit the method defined by the claim and has not been given weight in construing the claims. See Texas Instruments, Inc. v. International Trade Comm., 988 F.2d 1165, 1171, 26 USPQ2d 1018, 1023 (Fed Cir. 1993) (“A ‘whereby’ clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim.”). See also Minton v. National Assoc. of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003) (“A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.”).
Furthermore, because the same method as instantly recited in claim 1 is taught by Balczon, the supernatant collected in the method according Balczon would inherently be capable of biofilm degradation or inhibition or substantial attenuation of biofilm formation as in present claim 7. The teachings of Balczon thus provide for and anticipate all elements of present claims 1-9.
7. Claim(s) 1-9 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Voth et al. (Am. J. Respiratory Crit Care Med. 23 May 2018; 197, Issue Supplement 1: A7616; Poster Abstract).
Voth et al. teach the production of antimicrobial amyloids in a method that comprises infecting pulmonary microvascular endothelial cells (PMVECs) with DPcrV P. aeruginosa, which lacks a functional T3SS, for 4 hours at an MOI of 20:1 in buffer (HBSS; Hank’s balanced salt solution). Voth indicates that supernatants from these cultures were collected, centrifuged, filter-sterilized and transferred to monolayers of naïve PMVECs. The supernatant obtained from DPcrV-infected cells was not cytotoxic and was further found to exhibit antimicrobial activity against Pseudomonas spp., methicillin-resistant Staphylococcus aureus, Klebsiella pneumoniae, and Candida albicans. Such teachings thus provide for steps (a)-(c) of claim 1, the mammalian cell of claims 2-3, the infectious agent of claims 4-6, the amyloid protein properties of claim 7, the timing/methodology of claim 8, and the filter-sterilizing step (d) of claim 9.
And regarding claim 12, Voth teaches that the A11 (anti-amyloid oligomer) and T22 (anti-tau oligomer) antibodies were used to immunodeplete oligomeric species from the supernatants.
Conclusion
8. Claims 1-14 are rejected.
Claims 34-36 are allowed. The prior art does not teach or reasonably suggest a method as encompassed by these claims.
9. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. This prior art includes:
Kumar DK et al. Amyloid-b peptide protects against microbial infection in mouse and worm models of Alzheimer’s disease. Sci Transl Med. 2016; 8(340):340ra72.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kimberly A. Ballard whose telephone number is (571)272-2150. The examiner can normally be reached Mon-Fri 8AM - 5PM EST.
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/KIMBERLY BALLARD/Primary Examiner, Art Unit 1675
