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 .
Restriction/Election of Species
In their Response filed on 15 April 2026, Applicant elected Group I, claims 1-4 and 9-10, without traverse.
In their Response filed on 15 April 2026, Applicant elected the following species, without traverse: Bacteriophage: LBL3 phage; Bacteria: Pseudomonas aeruginosa; Biopolymer set: alginate, chitosan, and hyaluronic acid polysaccharides; Linking agent set: multi-arm PEG and linear PEG, each including aldehyde and/or benzaldehyde groups; Functionalizing agent set: hydrazine-based functionalizing agents; Connection between the bacteriophage and the hydrogel: imine bonds; and Reactive groups: phage lysine or amine groups and aldehyde and/or benzaldehyde groups of biopolymer and/or linking agent.
Claims 1-3 and 9-10 read on the elected species, but not Claim 4, even though it was part of the elected group. As such, Claim 4 is withdrawn from consideration.
Claims 1-4, 9-15, 17-19, and 21-26 are currently pending, with Claims 4-8, 11-15, 17-19, and 21-26 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 15 April 2026.
Disposition of Claims
Accordingly, Claims 1-3 and 9-10 will be examined on their merits.
Examiner’s Note
All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US 2024/0173370 A1, Published 30 May 2024. Applicant’s amended Specification as presented on 25 September 2023 is acknowledged and entered.
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.
Information Disclosure Statement
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.
The information disclosure statements (IDSes) submitted on 25 September 2023 and 15 April 2026 have been considered by the examiner.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains legal phraseology, specifically in the form of “e.g.”, which stands for “exempli gratia”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 1 is objected to because of the following informalities: it is suggested that it say “…wherein at least a portion of each of the bacteriophages is connected…” instead of “…wherein each of at least a portion of the bacteriophages is connected…”.
Appropriate correction is required.
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.
For the purpose of examining these claims on their merits, Examiner is stating on the record that not all of the species elected by Applicant are actually recited in the claims as currently written. As such, the prior art does not have to meet the limitations of the elected species which are not actually recited in the instant claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Hosseinidoust (WO 2021/003582 A1, Published 14 January 2021) (cited by Applicant on IDS filed on 25 September 2023) and Hersel et al. (U.S. Patent No. 10,029,015 B2, Issued 24 July 2018) (cited by Applicant on IDS filed on 25 September 2023).
Hosseinidoust teaches hydrogel compositions comprising physically and/or chemically a cross-linked plurality of bacteriophages (see Abstract; Page 1, Lines 3-4; Page 7, Lines 25-26), wherein the hydrogel comprises a water-swellable polymeric matrix consisting of a three-dimensional network of hydrogel polymers, such as alginate (see Page 9, Lines 3-9), held together by covalent or non-covalent crosslinks (see Page 9, Lines 3-9) and the bacteriophages are located within the hydrogel (see Page 11, Lines 26-27). Hosseinidoust also teaches hydrogel compositions wherein the hydrogel and bacteriophages are cross-linked due to a reaction between the amine groups of lysine residues on the phage coat/major capsid protein and two aldehyde groups in glutaraldehyde (see Page 7, Lines 19-21; Page 16, Lines 22-29) and wherein the hydrogel exhibits self-healing due to the crosslinking reaction (see Abstract; Page 7, Lines 14-17; Page 9, Lines 19-23; Page 17, Lines 16-23; Page 18, Lines 2-3; Page 19, Lines 4-8; Figures 7-10). As the prior art hydrogel has the same composition as the instant hydrogel, the instant limitation of being “engineered to facilitate a sustained release of the connected bacteriophages” is also an inherent property of the prior art hydrogel, even though the prior art does not explicitly teach its hydrogel composition for the sustained release of bacteriophages (consider MPEP 2112 II). As such, the prior art disclosure teaches this limitation of the instant claims.
Hosseinidoust does not teach a hydrogel composition wherein the hydrogel has an average pore size between 3 nm and 30 nm.
Hersel et al. teach hydrogel formulations wherein the hydrogel has a plurality of pores with openings on its surface and the diameter of the pores is larger than the biologically active moiety (see Abstract). Hersel et al. also teach wherein the hydrogel comprises pores that are larger than 1 nm but smaller than 100 nm (see Column 1, Lines 36-40) and wherein, when covalent bonds are used, the biologically active moiety is reversibly attached to the hydrogel and its release is prevented by the covalent attachment and wherein the average size of the pore of the hydrogel is larger than the diameter of the biologically active moiety (see Column 5, Lines 20-26; Column 8, Lines 46-54).
A person having ordinary skill in the art would have been motivated to combine the teachings of Hosseinidoust with those of Hersel et al. in order to develop a hydrogel with a certain average pore size. The range of pore sizes disclosed by Hersel et al. encompasses the range recited by the instant claims and therefore Hersel et al. teach hydrogels with pore sizes at all the sizes recited by the instant claims. It would have been obvious to apply the teachings of Hersel et al. to the bacteriophage hydrogel of Hosseinidoust because, as Hersel et al. disclosed, when utilizing crosslinking to form covalent bonds between the bacteriophages and the hydrogel, the average pore size can be larger than the diameter of the biologically active moiety, the bacteriophage in the case of Hosseinidoust, as there is less danger of the bacteriophage leaking out of the hydrogel prematurely due to the crosslinking. The determination of the average pore size used for the hydrogel would be dependent on, or a result of, the biologically active moiety comprised within said hydrogel. In other words, the average pore size is a result-effective variable. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, and the prior art teaches that parameter magnitudes that are encompassed by instant claims, often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the art. The combination of these characteristics would have led to the development of a bacteriophage hydrogel composition with an appropriate average pore size for the bacteriophage being used, making the hydrogel more therapeutically effective and thus rendering the instant claims obvious.
For at least these reasons, instant Claims 1-3 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over the prior art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 10, 32-33 of copending Application No. 19/163,176 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a hydrogel comprising a plurality of molecules wherein the hydrogel has aldehyde groups and comprises a polymer comprising alginate. Both claim sets are also drawn to a hydrogel comprising a plurality of molecules wherein said molecules and the hydrogel are connected via dynamic covalent bonds, specifically imine bonds, which are formed when amines on the molecules react with aldehyde groups within the interior of the hydrogel. The main difference between the claim sets is that the instant claims only recite a plurality of bacteriophages, while the reference claims more generically recite a plurality of amine-containing antimicrobial agents wherein a plurality of bacteriophages is one possible species of the genus of amine-containing antimicrobial agents. As such, the reference claims and the instant claims are overlapping in scope and the claims sets read on each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
The prior art made of record, but not relied upon, and considered pertinent to applicant's disclosure is listed below:
Ceyssens et al. (Ceyssens PJ, Miroshnikov K, Mattheus W, Krylov V, Robben J, Noben JP, Vanderschraeghe S, Sykilinda N, Kropinski AM, Volckaert G, Mesyanzhinov V, Lavigne R. Comparative analysis of the widespread and conserved PB1-like viruses infecting Pseudomonas aeruginosa. Environ Microbiol. 2009 Nov;11(11):2874-83.).
Ceyssens et al. teach the similarities between different bacteriophages which infect Pseudomonas aeruginosa, such as LBL3. This reference has not been utilized, as rejection would have been redundant to those set forth above.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAREY A STUART whose telephone number is (703)756-4668. The examiner can normally be reached Monday - Friday, 7:30 AM - 4:30 PM 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, Michael Allen can be reached at 571-270-3497. 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.
/CAREY ALEXANDER STUART/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
Prosecution Insights