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 .
Applicant’s amendment submitted on 3/23/2026 is acknowledged. All of the amended claims submitted on 3/23/2026, claims 1-8, are under examination on the merits.
Withdrawn Objections
The following objections are withdrawn due to Applicant’s amendment submitted on 3/23/2026:
Specification: for containing an embedded hyperlink.
Claims: claims 58 and 8 for minor informalities.
Withdrawn Rejections
The following rejections are withdrawn due to Applicant’s amendment submitted on 3/23/2026:
35 U.S.C. §112(b): claim 6.
35 U.S.C. §101: claim 6.
35 U.S.C. §103: claims 1 & 3-4 as being unpatentable under 35 U.S.C. 103 over Bergwerff, et al. (WO 2012158041 A1, published 11/22/2012; hereinafter referred to as “Bergwerff”) in further view of Xie, et al. (Viruses. 2018 Apr 12;10(4):189. PMID: 29649135; hereinafter referred to as “Xie”) and Benesik (Comparison of two phages for potential commercial use—genomes, host spectrum and declaration of nontoxicity, 100th Centennial Celebration of Bacteriophage Research, 1/1/2017, abstract; hereinafter referred to as “Benesik”) and Manohar, et al. (Sci Rep. 2019 Oct 23;9(1):15242. PMID: 31645642; hereinafter referred to as “Manohar”); Claims 5 & 6 as being unpatentable under 35 U.S.C. 103 over Bergwerff, Xie, Benesik, and Manohar (supra), as applied to claims 1 & 3-4 above, and further in view of Mosa, et al. (WO 2014048407 A2, published 4/3/2014; hereinafter referred to as “Mosa”); and Claim 8 as being unpatentable under 35 U.S.C. 103 over Bergwerff, Xie, Benesik, and Manohar and Foddai (supra), as applied to claims 1-4 & 7 above, and further in view of Mosa (supra).
New Objections
Claim Objections
Claims 1 and 6 are objected to because of the following informalities: the claims recite “wherein the phage is selected from the group consisting of MB401, MB402, MB403, MBSA2, MBSA3, and MBSA5, deposited at the Leibniz Institute DSMZ, German Collection of Microorganisms and Cell Cultures GmbH under the accession numbers DSM 33472, DSM 33473, DSM 33474, DSM33475, DSM33476, and DSM 33477” on lines 6-9 (claim 1) and lines 9-13 (claim 6). The claims should recite “, respectively” after “DSM 33477”. Appropriate correction is required.
Claims 1, 3, and 6 are objected to because of the following informalities: Claims 1 and recite 6 “wherein each series of wells comprises at least 50 µl of a strain of lyophilized S. aureus phage lysate at a concentration differing by one order from 1x109 to 1x102” (lines 4-5 and lines 8-9, respectively), claim 3 states “the phage lysate in unit dilutions within one order at concentrations of 1x109-9x109, 1x108-9x108, 1x107-9x107, 1x106-9x106, 1x105-9x105, 1x104-9x104, 1x103-9x103, and 1x102-9x102 PFU/ml (lines 1-3), and claim 6 further states “at a concentration on the order of 107, or dilution to -3, indicates sensitivity of the test sample of S. aureus bacteria to the phage and that a turbid test sample inoculated with the S. aureus phage lysate at concentrations of 1x109 to 1x102 indicates resistance of the test sample of S. aureus bacteria to the phage” (part d). Although the specification does not define “order”, it is clear, based on the specification in general and absolute values provided by the claims that the claims mean “order of magnitude”, or the ratio of the greater number to the lesser number is between 1 and 10. However, that is complicated by the fact that meaning of “order” can change when the ratio scale is not based on powers of ten (for example, an order of magnitude is different when the ratio scale is based on powers of two, or some other number). To put the claims in better format, reference to an order should be removed, and instead absolute values, with proper unit identifiers (e.g., “PFU/ml” or “genome copies”) should be used in the claims.
New Rejections
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.
Claims 1-2 and 4-8 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.
The term “stable” in claims 4 and 7 is a relative term which renders the claim indefinite. The term “stable” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “stable” refers to the test kit, but it is unclear what requirement must be met such that the test kit reaches the threshold of “stable”. For instance, whether a percentage of activity is maintained, and if so, what level of activity must be maintained for what period of time.
Claims 1 and 6 recite “wherein each series of wells comprises at least 50 µl of a strain of lyophilized S. aureus phage lysate at a concentration differing by one order from 1x109 to 1x102” (lines 4-5 and lines 8-9, respectively), and claim 6 further states “at a concentration on the order of 107, or dilution to -3, indicates sensitivity of the test sample of S. aureus bacteria to the phage and that a turbid test sample inoculated with the S. aureus phage lysate at concentrations of 1x109 to 1x102 indicates resistance of the test sample of S. aureus bacteria to the phage” (part d). However, the claims do not indicate what the unit of this concentration is. For example, the concentration could be in PFU/ml (as in claim 3), or genome copies, etc. The presence of multiple interpretations renders the claims indefinite. Claims 2, 4-5, and 7-8 depend from claim 1 but do not remedy this lack of clarity, and are thus also indefinite and rejected.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5 and 7-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. The claims recite a lyophilized Staphylococcus aureus phage test kit for determination of biological antimicrobial activity of a phage lysate, comprising: a microtitration plate comprising individual wells of one or more series of wells, wherein each series of wells comprises at least 50 µl of a strain of lyophilized S. aureus phage lysate at a concentration differing by one order from 1x109 to 1x102, wherein the phage is selected from the group consisting of MB401, MB402, MB403, MBSA2, MBSA3, MBSA5, deposited at the Leibniz Institute DSMZ, German Collection of Microorganisms and Cell Cultures GmbH under the accession numbers DSM 33472, DSM 33473, DSM 33474, DSM 33475, DSM 33476, and DSM 33477, and combinations thereof (claim 1). Additional claims require the test kit to further comprise CaCl2 at concentrations of 0.1-1 mM in the individual wells of the microtitration plate (claim 2), further comprising the phage lysate in unit dilutions within one order at specific concentrations (claim 3), the kit to be stable at a temperature of 0-25 °C (claims 2 & 4), or further comprising a lyophilized S. aureus bacteria sensitive to the strain of the phage (claims 5 & 7).
Claim interpretation: Under the broadest reasonable interpretation, the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. The claimed phage(s) appear to be natural phages, as indicated in the January 26, 2022 Response to the Written Opinion of the International Searching Authority attached as Exhibit A, the DSMZ Accession Numbers now cited in the claims define specific, newly isolated microorganisms”. Further, the specification does not indicate that the phages MB401, MB402, MB403, MBSA2, MBSA3, and MBSA5 deposited at Leibniz Institute DSMZ, German Collection of Microorganisms and Cell Cultures GmbH under the accession numbers DSM 33472, DSM 33473, DSM 33474, DSM 33475, DSM 33476, and DSM 33477, were otherwise genetically modified from natural isolates. Accordingly, the examiner concludes that the phage MB401, MB402, MB403, MBSA2, MBSA3, and MBSA5 deposited at Leibniz Institute DSMZ, German Collection of Microorganisms and Cell Cultures GmbH under the accession numbers DSM 33472, DSM 33473, DSM 33474, DSM 33475, DSM 33476, and DSM 33477 are also natural phage isolates, absent evidence provided by Applicant.
Step 1: Here, the claims recite a lyophilized S. aureus phage test kit, comprising a microtitration plate comprising series of wells, each series of wells comprising at least 50 µl of a strain of lyophilized S. aureus phage lysate at a concentration differing by one order from 1x109 to 1x102. Each of the microtitration plate and lyophilized S. aureus phage lysate is a composition of matter, which is a statutory category of invention (Step 1: YES).
Step 2A Prong One: As explained in MPEP 2106.04(II) and the October 2019 Update, a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim. Because claim 1 recites a nature-based product limitation (the phage(s)), the markedly different characteristics analysis is used to determine if the nature-based product limitation is a product of nature exception. MPEP 2106.04(c)(I). Although the claim also recites a non-nature based product limitation (the microtitration plate comprising individual wells of one or more series of wells), the markedly different characteristics analysis should be applied only to the nature-based product limitation. MPEP 2106.04(c)(I)(A). The markedly different characteristics analysis is performed by comparing the nature-based product limitation in the claim to its naturally occurring counterpart to determine if it has markedly different characteristics from the counterpart. MPEP 2106.04(c)(II). Here, the closest natural counterpart is naturally occurring phage(s). When the claimed phage(s) is compared to this counterpart, the comparison indicates that there are no differences in structure, function, or other characteristics. Therefore, the claimed phage(s) is a product of nature exception. Association for Molecular Pathology v. Myriad Genetics Inc., 569 U.S. 576, 589-90 (2013) (naturally occurring things are “products of nature” which cannot be patented). Accordingly, the claims recite a judicial exception, and the analysis must therefore proceed to Step 2A Prong Two.
Step 2A Prong Two: This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. 2019 PEG Section III(A)(2), 84 Fed. Reg. at 54-55. Claim 1 recites additional elements (the microtitration plate, lyophilized S. aureus phage lysate at a concentration differing by one order from 1x109 to 1x102). Ultimately, lyophilization requires isolation of the phage but not structurally changing it, as evidenced by the phage being active and functional later. Any added claim element does not change the structure or is natural on its own. For instance, diluting and adding the natural phage isolates to a plate is insufficient as an additional element to show the hand of man. Additionally, the limitations required by the dependent claims do not amount to significantly more than the judicial exception, because CaCl2 is naturally occurring and could be present with a natural phage isolate, a dry (lyophilized) phage would naturally be stable to some degree (although the limitation “stable” is indefinite for the reasons described in the rejection under 35 U.S.C. §112(b) above), and dried (lyophilized) S. aureus bacteria is naturally occurring and could be present with a natural phage isolate. Notably, the specification indicates that “one of the options of enhancing stability of phages is lyophilization, which generally prevents degradation of proteins and biological materials, thus extending stability” (p. 3). Therefore, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception (Step 2A: YES).
Step 2B: No additional element, or combination of additional elements, adds an inventive concept to the claims. MPEP 2106.05. No non-judicial exception element is present in the claims that is structurally changing the exception (phage) or giving it properties that it did not have before. (Step 2B: NO). The claims are not eligible under 35 U.S.C. §101.
Accordingly, claims 1-5 and 7-8 are rejected under 35 U.S.C. §101.
Conclusion
No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY MARK SIFFORD whose telephone number is 571-272-7289. The examiner can normally be reached 8:30 a.m. - 5:30 p.m. ET with alternating Fridays off.
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/JEFFREY MARK SIFFORD/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
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