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 .
Claims 1-34 are currently pending.
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-22, drawn to compositions comprising peptidoglycans and heat shock proteins, classified in A61K 2039/70.
II. Claims 23-26, drawn to methods of treating infections in a mammal comprising administering the immunogenic portion of a peptidoglycan and a heat shock protein, classified in CN12N 2770/20034.
III. Claims 27-34, drawn to antibodies that bind the immunogenic portion of the peptidoglycan and heat shock protein and hybridomas capable of producing such antibodies, classified in C07K 16/00.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h).
In the instant case, the process of Group II is a process of treating infection and this process comprises administering the instant claimed PGN-HSP polypeptide of claim 1 a patient in need thereof. However, a process of treating infection can also be practiced by administration of antibiotics.
Inventions I and III and inventions III and II are unrelated. Inventions are unrelated if it can be shown that they are not disclosed as capable of use together and they have different designs, modes of operation, and effects (MPEP § 802.01 and § 806.06). In the instant case, the different inventions are the immunogenic composition present in groups I and II and the antibodies of group III. The invention of the antibodies of group III cannot be used with the immunogenic composition of groups I and II because the antibodies of group III are exogenous immunoglobin composition administered to a patient, which works by binding to bacteria presenting the corresponding antigens whereas the immunogenic composition of groups I and II are antigens that are administered to a patient and work by inducing the production of the patient’s own antibodies.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions have acquired a separate status in the art in view of their different classification
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
During a telephone conversation with Jim Reminik on 5/11/2026 a provisional election was made with traverse to prosecute the invention of Group III, claims 27-34. Affirmation of this election must be made by applicant in replying to this Office action.
Applicant's election with traverse of Group III in the reply filed on 5/11/2026 is acknowledged. The traversal is on the ground(s) that the search for each of the three groups would yield the same references. This was not found to be persuasive as groups I and II are properly restrictable product/process of groupings and the invention of the antibodies of group III is unrelated to the other two groupings of inventions, as outlined above. Additionally, there would be a search burden searching all the groups because each of the three groups would require searching different fields of research. Group I would require a search literature related to immunogenic peptides/fusion peptides. Group II would require a search of the medical literature, as group II is directed to methods of treating. Group III would require a search of literature related to antibodies and antibody structures.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-26 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 27-34 will be examined on the merits.
Claim Rejections - 35 USC § 112
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 33-34 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 33 recites a hybridoma of ATCC No PTA-127658 as part of the claimed invention. As required elements such cells must be readily available or obtainable by a repeatable method set forth in the specification, or otherwise readily available to the public. If it is not so obtainable or available, the enablement requirements of 35 U.S.C. § 112, first paragraph, may be satisfied by a deposit of the cell lines listed in claim 33. See 37 CFR 1.802.
The specification does not teach how to make the cell line PTA-127658. The instant specification does not teach any modifications to the cell lines, and further it is not apparent if any of the cell lines, would be known and readily available to the public.
Search of the instant specification does not indicate that the Applicant has deposited the biological materials with the required certification.
If the deposit is made and is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit, that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
If the deposit is made, but not under a non-Budapest Treaty deposit, then in order to certify that the deposit meets the requirements set forth in 37 CFR 1.801 -1.809 and MPEP 2402-2411.05, a statement, affidavit or declaration Applicant, by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit would satisfy the requirements herein by stating and providing that:
During the pendency of the application, access to the invention will be afforded to the
Commissioner upon request;
(b) All restrictions upon availability to the public will be irrevocably removed upon granting of
the patent;
© The deposit will be maintained in a public depositary for a period of 30 years, or 5 years
after the last request or for the enforceable life of the patent, whichever is longer; and
(d) Provide evidence of the test of the viability of the biological material at the time of deposit (see 37 CFR 1.807).
In addition the identifying information set forth in 37 CFR l.809 (d) should be added to the specification. See 37 CFR 1.803 – 37 CFR 1.809 for additional explanation of these requirements.
Amendment of the specification to recite the date of deposit and the complete name and address of the depository is required. As an additional means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
If a deposit is made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the biological material described in the specification as filed is the same as that deposited in the depository, stating that the deposited material is identical to the biological material described in the specification and was in the applicant’s possession at the time the application was filed.
Applicant’s attention is directed to In re Lundak, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR 1.801-1.809 for further information concerning deposit practice.
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.
Claim(s) 27-32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schuman (Schuman, et al., WO 03059259 A2; Published 7/24/2003).
Regarding claims 27 and 31, Schuman discloses monoclonal antibodies that bind to peptidoglycan of Gram-positive bacteria and, as such, are antibodies that would bind the composition of claim 1 (Schuman, Abstract). Regarding claims 27-31, Schuman discloses monoclonal antibody Mab-11-232.3, an IgG anti-peptidoglycan antibody capable of inducing opsonophagocytic killing of S. epidermidis (Schuman, Table 13, p 54). Regarding claim 32, Schuman discloses hybridoma 11-232.3 IE9, which produces the anti-peptidoglycan antibody M130 (Schuman, ¶ 0155).
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 27-34 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 8-9 of copending Application No. 19/356,950 (not yet published) as evidenced by Fischer (Fischer, et al., US 20250325654; published 10/23/2025) and Longhorn (Longhorn, et al., Longhorn Vaccines and Diagnosics to Present New Data on DRG5-BD11 Showing Broad activity against multiple Bacterial Classes at ESCMID (2026); Publisher: Business Wire; URL = https://www.businesswire.com/news/home/20260415128689/en/Longhorn-Vaccines-and-Diagnostics-to-Present-New-Data-on-DRG5BD11-Showing-Broad-Activity-Against-Multiple-Bacterial-Classes-at-ESCMID-2026; First available 4/15/2026; accessed 5/28/2026)
Fischer teaches that the name of the monoclonal antibody produced by the hybridoma line PTA-127658 is known as DRG-5BD11 (Fischer, p 0068).
Regarding instant claims 32-34, copending claims 8-9 are directed to a hybridoma cell line deposited with ATCC as Accession No. PTA-127658 and the antibodies produced by such hybridomas.
Regarding claim 27, Fischer provides evidence that antibody the DRG-5BD11 produced by cell line PTA-127658 is an antibody that binds both PGN and HSP16.3 (a heat shock protein) (Longhorn, page 1, p 2- page 3, p 1). Regarding claim 28 and 31, Longhorn provides evidence that the DRG-5BD11 produced by cell line PTA-127658 is a monoclonal IgM antibody (Longhorn, Abstract). Regarding claims 29-30, Longhorn provides evidence that the DRG-5BD11 produced by cell line PTA-127658 demonstrates opsonophagocytic killing vs E. coli and Mycobacterium smegmatis.
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Subject Matter Free of Prior Art
Claims 33-34 are free of prior art.
The following is a statement of reasons for the indication of subject matter free of prior art:
Instant claims 33-34 are directed to a hybridoma comprising the cells of ATCC deposit number PTA-127658 as well as antibodies produced by such cells. The instant disclosure teaches that the hybridoma PTA-127658 is a cell line that produces peptidoglycan IgM antibodies known as DRG-5 BD11 and the hybridoma is also known as clone DRG-5 BD11II E6 II G1 and is derived from mouse clone DRAGA 5 (Specification, p 22; Table 1). A search of the prior art was performed for the ATCC deposit number as well as the antibody ID, clone ID and mouse clone ID and no results that qualify as prior art were found.
The next nearest prior art identified was ThermoFisher (Thermo Fisher, et al., 3F6B3 (10H6); Url = https://www.thermofisher.com/antibody/product/Peptidoglycan-Antibody-clone-3F6B3-10H6-Monoclonal/MA5-16509; first available 9/21/2016; Accessed 5/12/2026). ThermoFisher discloses anti-peptidoglycan antibody 3F6B3 (10H6), which is an anti-peptidoglycan antibody obtained by TCA-heat and ethanol extraction of Streptococcus mutant BHT cells (ThermoFisher, p 3). As such, anti-peptidoglycan antibodies were known in the art before the filing date of the instant application, however as stated above, the prior art is silent on hybridoma PTA-127658, clone DRG-5 BD11II E6 II G1, mouse clone DRAGA 5 as well as antibody DRG-5 BD11. As such, one of ordinary skill in the art would be unlikely to start with the cell line producing anti-peptidoglycan antibody 3F6B3 (10H6) (or any other anti-peptidoglycan antibody) and arrive at cell line PTA-127658. As such, cell line PTA-127658 as well as the antibodies it produces are free of prior art and claims 33-34 are free of prior art.
Conclusion
Claims 27-34 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sydney Van Druff whose telephone number is (571)272-2085. The examiner can normally be reached 10 am - 6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SYDNEY VAN DRUFF/Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643
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