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
Applicant's election with traverse of Group I, claims 1-12, 14, 17, 38, and 40, in the reply filed on 01/29/2025 is acknowledged. The traversal is on the ground(s) that no unreasonable search or examination burden exists because multiple searches would likely yield a limited number of reference. This is not found persuasive because the restriction was required between a product and a process of using the product and each invention has acquired a separate status in the art as a separate subject for inventive effort and require independent searches.
The requirement is still deemed proper and is therefore made FINAL.
Claims 19, 25, 28, and 37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/29/2025.
Status of the Claims
Claims 1-12, 14, 17, 19, 25, 28, 37-38, and 40 are currently pending.
Claims 19, 25, 28, and 37 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 13, 15-16, 18, 20-24, 26-27, 29-36, 39, and 41 are cancelled.
Claims 1-12, 14, 17, 38, and 40 have been considered on the merits.
Claim Objections
Claim 1 is objected to because of the following informalities: “wherein the antimicrobial comprises” in line 3 should be amended to “wherein the antimicrobial agent comprises”. Appropriate correction is required.
Drawings
The specification makes reference to the colors blue and red in reference to the drawings in at least paragraphs [0089], [0091], and [0092].
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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.
Claim 8 is 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 8 recites the broad recitation “wherein the one or more antimicrobial agent does not comprise tetracyclines, macrolides, sulfonamides, lincosamides, trimethoprim, chloramphenicol, or rifampin”, and the claim also recites “further, wherein tetracyclines, macrolides, sulfonamides, lincosamides, trimethoprim, chloramphenicol, and rifampin are excluded from the composition” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. It is not clear if claim 8 is requiring that at least one of the listed antimicrobial agents is not present in the composition of if all listed antimicrobial agents must not be present in the composition. For the sake of compact prosecution, the claim is being interpreted to require that all of the listed antimicrobial agents are not included in the composition. Appropriate clarification is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-12, 14, 17, 38, and 40 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Dow et al (US20180360855A1).
Claim interpretation: Claims 9-11 are directed to an intended use of the claimed composition and therefore carry little patentable weight. Therefore, the limitations of claims 9-11 are met by any composition of the prior art reading on claim 1.
Regarding claim 1, Dow teaches a composition comprising Toll like receptor 3 (TLR3) ligand activated mesenchymal stem cells (MSCs) ([0005]) and one or more antimicrobial agents wherein the antimicrobial agent comprises at least one bactericidal antimicrobial agent with reduced cytotoxicity against mammalian cells ([0014]).
Regarding claim 2, Dow teaches that the antimicrobial agent is a bactericidal antibiotic ([0014]).
Regarding claim 3, Dow teaches that the bactericidal antimicrobial agent can comprise one or more of various antibiotics including carbapenems, which are a class of commonly used gram-negative antibiotics, and penicillin derivatives, vancomycin, and erythromycin, which are commonly used gram-positive antibiotics ([0014]).
Regarding claim 4, Dow teaches the composition further comprises an antimicrobial peptide agent ([0199]).
Regarding claim 5, Dow teaches that the one or more antimicrobial agents comprise one or more of vancomycin ([0014]), cefazolin ([0188]), and clindamycin ([0014]). Additionally, Dow teaches the use of penicillin derivatives which would include the claimed ampicillin-sulbactam ([0014]).
Regarding claim 6, Dow teaches wherein the one or more antimicrobial agents comprise one or more of carbapenems, which meets the claimed limitation “and other carbapenem class antibiotics”, however the carbapenem class would include imipenem, ceftriaxone, and ceftazidime ([0014]).
Regarding claim 7, Dow teaches various antibiotics are possible to include in the composition however, Dow also teaches a specific embodiment in Example 1 which only includes the antibiotic of amoxicillin-clavulanic acid which demonstrates an embodiment of the composition which does not contain aminoglycosides, fluroquinolones, tetracyclines or neomycin (Example 1/ [0166]-[0170]). Additionally, Dow teaches by omission that the composition does not contain neomycin because it is not a recited antibiotic anywhere within the disclosure of Dow.
Regarding claim 8, Dow teaches various antibiotics are possible to include in the composition however, Dow also teaches a specific embodiment in Example 1 which only includes the antibiotic of amoxicillin-clavulanic acid which demonstrates an embodiment of the composition which does not contain tetracyclines, macrolides, sulfonamides, lincosamides, trimethoprim, chloramphenicol, or rifampin and wherein these are excluded from the composition (Example 1/ [0166]-[0170]).
Regarding claim 9, the limitations recited are an intended use and therefore do not carry patentable weight. However, Dow teaches that the composition is used for direct delivery to an infected joint of a canine ([0083]/[0214]).
Regarding claim 10, the limitations recited are an intended use and therefore do not carry patentable weight. However, Dow teaches that the composition can comprise a liquid ([0138]) gel, ointment, salve or cream ([0147]).
Regarding claim 11, the limitations recited are an intended use and therefore do not carry patentable weight. However, Dow teaches direct delivery to a knee joint in canines, also known as a stifle joint in canines ([0209]-[0212]).
Regarding claim 12, Dow teaches that the MSCs are autologous or allogeneic ([0139]) and derived from bone marrow, adipose tissue, cord blood, or tissue biopsies ([0006]).
Regarding claim 14, Dow teaches that the TLR3 ligands comprises one or more of polyadenylic-polyuridylic acid (poly(A:U)), polyinosine-polycytidylic acid (poly(I:C) or pIC), or UV-inactivated viral particles ([0008]).
Regarding claim 17, Dow teaches that the MSCs comprise human derived MSCs ([0121] and claim 27), and that they may be allogeneic or autologous which meets the limtiations of being “directly from the subject to be treated or from an unrelated donor” ([0139]).
Regarding claim 38, Dow teaches that the composition includes a pharmaceutically acceptable agent or excipient ([0005]/[0138]).
Regarding claim 40, Dow teaches the composition can be included in a kit with at least one container ([0151]-[0154]).
Therefore, Dow anticipates the claims.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONSTANTINA E STAVROU whose telephone number is (571)272-9899. The examiner can normally be reached M-F 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached at 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632