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 .
Claim Status
The amended claim set filed 23 Sep 2025 is acknowledged. Claims 1-4, 6-8, 10-14, 16-18, 21-24, 26-28, 30, and 41-42 are currently pending. Of those, claims 1,-3, 6-7, 10-14, 16-18, 21-23, 26-27, 30, and 41-42 are currently amended, and no claims are new. Claims 21-24, 26-28, and 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3 Jun 2025. Claims 5, 9, 15, 19-20, 25, 29, 31-40 are cancelled. Claims 1-4, 6-8, 10-14, 16-18, and 41-42 will be examined on the merits herein.
Response to Arguments
The Applicants’ arguments filed 23 Sep 2025 are acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks” and the Non-Final Office Action mailed 16 July 2025 will be referred to as “NFOA.”
Priority
In view of the amendments and arguments pointing out that the claims no longer recite an adjuvant, the effective filing date used for searching claims 1-4, 6-8, 10-14, 16-18, and 41-42 is 22 May 2020.
Objection(s) and Rejection(s) Withdrawn
The objection to the specification related to the sequence listing is withdrawn in view of the amended specification, new sequence listing, and statement that no new matter is introduced.
The claim objections to claims 1-20 and 41-42 and 9 and 19 are withdrawn in view of the claim amendments.
The rejections of claims 5, 9, 15, and 19-20 under 35 U.S.C. 112(d) are moot and withdrawn because the claims have been deleted.
The rejection of claims 1-10 and 41 under 35 U.S.C. 112(b) is withdrawn in view of the claim amendment and argument.
The rejection under 35 U.S.C. 112(a) is withdrawn in part; it is withdrawn for claim 1 and its dependent claims in view of claim amendments and arguments, but is maintained for claim 11 and its dependent claims (see below).
Rejection(s) Maintained
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 11-14, 16-18 and 42 remain 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 live strains of S. aureus lacking adenosine synthase A (AdsA) activity, and kits comprising a container comprising either the live strain, does not reasonably provide enablement for live strains for use in preventing and/or treating S. aureus infection, vaccines, and immunization, for the reasons of record and the reasons herein.
Applicant argues (Remarks pg. 10) that “Claims 1 and 11 are amended to further limit the vaccine or strain as "not in a form for intravenous administration", the basis for which is in original claims 10 and 20, respectively. … Similar as stated above, the different functional results in Example 1 and Example 5 are due to the different administration ways. Based on results as recited in Examples 1 and Example 5, it would be understood that when preparing a vaccine, or in a method of treating Staphylococcus aureus infection, using the mutant S. aureus strain, the administered composition not in a form for intravenous administration will achieve the effect of raising an immune response but without being lethal.” (The reference to “above” is found at Remarks pg. 9-10 which discusses the details of Examples 1 and 5 in more detail).
This argument has been carefully considered but is not found persuasive. For the live strain (claim 11 and its dependent claims), the new clause is not a limitation because the claim is a bacterial strain rather than a composition or method of use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Applicant has not argued or provided any evidence that the bacteria’s structure itself would be modified by not being in a form for intravenous administration. In fact, contrary to applicant’s arguments, the same strain is used in Examples 1 (intravenous injection) and 5 (peritoneal injection).
Therefore, the claims remain rejected for the reasons of record and the reasons herein.
New Rejection(s)
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 1-4, 6-8, 10 and 41 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 1 has been amended to recite “A vaccine for preventing or treating Staphylococcus aureus… and the vaccine is not in a form for intravenous administration.” The specification does not define how to determine whether a vaccine is in a form for intravenous administration or whether it is not. The specification teaches that both Example 1 (intravenous administration, [0095]) and Example 5 (intraperitoneal administration, [0100]) comprise only the bacteria, but presumably the injections of the examples also comprise some pharmaceutically acceptable carrier. The art corroborates that the identical composition can be administered in several different ways. Wang et al. (2016; PTO-892) specifically teaches that the same composition (mesenchymal stem cells “MSCs” at concentration 1×106, 200 μL in volume) can be administered by three delivery routes (intraperitoneal, anal injection, and intravenously) (Abstract and pg. 10 “Acute Colitis Induction and Cell Transplantation”). One of ordinary skill in the art would not be able to determine what structural features differentiate non-claimed compositions “in a form for intravenous administration” from claimed compositions that are in a form for other injections as explicitly recited in dependent claim 10, when the art teaches that the same composition can be administered both ways. Therefore, one of ordinary skill in the art would consider the claim scope to be indefinite. Claims 2-4, 6-8, 10 and 41 are also rejected because they depend from claim 1 and do not obviate this grounds of rejection. For the sake of compact prosecution, in this action, compositions are assumed to not be in a form for intravenous administration unless this administration is actually being performed.
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 1-4, 7-8, 10, and 41 rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
Claim 1 and its dependent claims recite compositions comprising a live strain of S. aureus deficient in AdsA activity, and optionally a pharmaceutically carrier, wherein the composition is not in a form for intravenous administration. Claims 2-4 recite that the S. aureus strain comprise a deleted AdsA gene, which is also a mutation that deletes the portion of AdsA responsible for adenosine production. Claim 10 recites that the composition is formulated in a form for intramuscular administration, intraperitoneal administration, subcutaneous administration, oral administration or intranasal administration, and claim 41 recites a kit comprising a container containing the composition of claim 1.
Ko et al. (2011; PTO-892) teaches that K07-561 is a strain isolated from hospitalized patients (pg. 442 col. 2 par. 1 and Table 1 on pg. 443), and Batool et al. (2021; PTO-892) provides evidence that “the AdsA protein was found to be absent in K07-561” (pg. 8 col. 1 par. 1). The post-effective filing date reference Batool et al. is cited to show a universal fact (i.e. the properties of the earlier-isolated strain). See MPEP 2124. Batool et al. Figure 1 shows that the adsA gene has been deleted from K07-561 (see claims 12-14). Ko et al. teaches that this naturally isolated strain was isolated from nature and can be placed into containers and cultures (“broth microdilution” pg. 442 col. 2 par. 1). The isolated strain in the laboratory setting is formulated for oral administration because the composition could be consumed, but is not in a form for intravenous administration because this procedure was not performed in Ko.
In Myriad, the Supreme Court made clear that not all changes in characteristics will rise to the level of a marked difference, e.g., the incidental changes resulting from isolation of a gene sequence are not enough to make the isolated gene markedly different. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. In this case, the isolated bacteria of Ko which has been placed into a container, is not markedly different from the natural isolate infecting a human prior to isolation. There are no disclosed changes in the strain’s genetics, biological properties, or phenotypic functions based on the isolation process described in Ko. Therefore, the isolated strain present in a container in a laboratory setting is not found to be markedly different from the natural isolate.
Regarding the intended use of being a vaccine for preventing or treating Staphylococcus aureus infection in claims 1 and 41, and the dependent claims 7-8 limiting the S. aureus infection that is prevented, these features are inherently taught by the composition in view of applicant’s arguments. See MPEP 2112: “"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). … There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference.” Applicant admitted (Remarks pg. 10) that “Based on results as recited in Examples 1 and Example 5, it would be understood that when preparing a vaccine, or in a method of treating Staphylococcus aureus infection, using the mutant S. aureus strain, the administered composition not in a form for intravenous administration will achieve the effect of raising an immune response but without being lethal.” Therefore, as applicant stated, the naturally occurring K07-561 S. aureus strain composition of Ko, which is not in a form for intravenous administration, will achieve the claimed effects. Therefore, these functional limitations do not differentiate the claimed product from the natural product.
This judicial exception is not integrated into a practical application because the vaccine claims of claims 1-4, 7-8, and 10 do not recite any required elements other than the natural product live bacterial strain. The container of claim 41 was found above to not be markedly different from the bacteria itself, but even if it were considered separately, the use of a generic container would amount to only insignificant extra-solution activity (see MPEP 2106.05(g)) due to being only nominally related to the invention. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the vaccine claims of claims 1-4, 7-8, and 10 do not recite any required elements. The container of claim 41 was found above to not be markedly different from the bacteria itself, but even if it were considered separately, the use of a generic container would amount to only insignificant extra-solution activity (see MPEP 2106.05(g)) due to being only nominally related to the invention.
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.
Claims 1-4, 6-8, 10 and 41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pernet et al. (2015; hereafter Pernet; IDS filed 17 Mar 2023).
Pernet teaches an S. aureus ΔadsA (i.e. adsA deletion) mutant made in the Newman strain background (pg. 5313 col. 1 par. 3, see claim 6) and teaches infecting guinea pigs intranasally with a composition comprising 5*107 CFUs in a pharmaceutically acceptable carrier (150 µL PBS) (pg. 5313 par. bridging cols.), and investigates its effect on certain parts of the immune system (Figure 6 legend on pg. 5317). This deletion is also a mutation that deletes the portion of AdsA responsible for adenosine production, because it deletes the full gene (see claims 2-4). The composition is in a form for intranasal, rather than intravenous administration (see claims 1, 10). Pernet teaches the strain composition is liquid (strain dissolved in PBS), so it also teaches a container comprising the composition and also teaches the containers required to intranasally administer the composition (pg. 5313 par. bridging cols., see claim 41).
Regarding the intended use of being a vaccine for preventing or treating Staphylococcus aureus infection, and the dependent claims 7-8 limiting the S. aureus infection that is prevented, these features are inherently taught by the composition in view of applicant’s arguments. See MPEP 2112: “"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). … There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference.” Applicant admitted (Remarks pg. 10) that “Based on results as recited in Examples 1 and Example 5, it would be understood that when preparing a vaccine, or in a method of treating Staphylococcus aureus infection, using the mutant S. aureus strain, the administered composition not in a form for intravenous administration will achieve the effect of raising an immune response but without being lethal.” Therefore, as applicant stated, the mutant S. aureus strain composition of Pernet, which is in a form for intranasal administration, will achieve the effect of raising an immune response but without being lethal. This unknown property that is inherently present in the prior art does not make the invention novel.
Conclusion
No claims are allowed.
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 CFR 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 CFR 1.17(a)) pursuant to 37 CFR 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIA NICOLE DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-R 8:30-4:30, and every other F 8:30-4:30 (EDT/EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Nickol can be reached at (571)272-0835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/GARY B NICKOL/Supervisory Patent Examiner, Art Unit 1645