DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/22/2025 has been considered by the examiner.
Status of the Claims
The claims filed 02/06/2026 are under consideration.
Claims 1-16 and 21-22 are pending.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Claim Objections
Claim 9 is objected to because of the following informalities: in claim 9, line 3: glucomate should be gluconate. Appropriate correction is required.
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 2, 3, and 7 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 pre-AIA the applicant regards as the invention.
Claims 2, 3, and 7 also use the term “about” with reference to minimum inhibitory concentrations. These claims are independently indefinite under the same rationale that the skilled artisan cannot determine how close to the recited values the MIC must be to infringe on the claimed values and ranges thereof.
The term “about” in claims 2, 3, and 7 is a relative term which renders the claim indefinite in light of the specification. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree with respect to values of MIC, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Clarification is required.
Further, claims 2 and 3 state a minimum inhibitory concentration. However, they do not indicate which bacteria the concentration refers to. The skilled artisan cannot understand which bacteria the stated concentration is required to be effective for.
Clarification is required.
Claim Rejections - 35 USC § 102
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 1-8, 10-14, 16, and 21 are rejected under 35 U.S.C. 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Montelaro, US 20090099533.
Montelaro teaches compositions comprising a peptide (Montelaro, e.g., 0013-0014, W12, Table 2) having the sequence RWWRWWRRWWRR which is 100% identical to seq id no: 17 as claimed. The peptide is based on the LBU series of peptides (Montelaro, e.g., 0057). Montelaro teaches the compositions may be used for coating (Montelaro, e.g., 0012, 0043 and fig. 21, 0102-0103, 0130, 0141), i.e., the compositions are considered coating materials.
Consequently, Montelaro teaches a pharmaceutical formulation meeting the limitations of claim 1.
Claims 2-7 recite properties of the composition according to claim 1. Since Montelaro teaches a pharmaceutical formulation meeting the limitations of claim 1, the properties Applicant claims are presumed to be present in the prior art compositions. Montelaro teaches peptides having SEQ ID NO: 10 are effective against the recited microorganisms (Montelaro, e.g., Examples 9 and 10, Fig. 26, WLBU-2 (SEQ ID NO: 10)).
Applicable to claim 8: Montelaro teaches the composition comprising a pharmaceutically acceptable excipient (Montelaro, e.g., 0014), e.g., water, buffers, surfactants, vegetable oils, sugars (Montelaro, e.g., 0111).
Applicable to claims 10-11: Montelaro names diluents (Montelaro, e.g., 0112), and water, glycerol, or ethanol (Montelaro, e.g., 0111).
Applicable to claim 12: Montelaro teaches the peptide in phosphate buffer at physiological conditions (Montelaro, e.g., 0122).
Applicable to claim 13: Montelaro teaches the composition further comprising an antibiotic (Montelaro, e.g., 0106).
Applicable to claim 14: Montelaro teaches compositions further comprising polyethylene glycol (Montelaro, e.g., 0099 and 0111).
Applicable to claim 16: Montelaro teaches compositions further comprising phenol for sterility (Montelearo, e.g., 0111).
Applicable to claim 21: Montelaro teaches coatings for medical devices (Montelaro, e.g., 0105 and example 7, 0141-0155).
Montelaro anticipates the subject matter of instant claims 1-8, 10-14, 16, and 21.
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 of this title, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-16, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Montelaro, US 20090099533 A1 in view of Constantino, US 20060052306 A1.
Montelaro teaches compositions according to claim 1, wherein the composition comprises a buffer (Montelaro, e.g., 0111), but does not expressly teach the buffering agents of claim 9.
However, buffering agents within the scope of claim 9 were known and used in similar peptide compositions as evident from Constantino. Constantino teaches pharmaceutical composition comprising peptides, which further comprise buffering agents such as magnesium hydroxide and/or aluminum hydroxide, Ringer’s salts, phosphate buffering agents (Constantino, .e.g., 0095).
It would have been obvious before the effective filing date of the presently claimed invention to modify compositions comprising a peptide which has a sequence identity with SEQ ID NO:14 within the scope of claim 1 by including buffering agents such as magnesium hydroxide and/or aluminum hydroxide with a reasonable expectation of success. Since Montelaro teaches composition containing the peptide further comprising biocompatible buffers, the skilled artisan would have been motivated to include known biocompatible buffering agents used in similar compositions to achieve the buffering capacity desired by Montelaro with a reasonable expectation of success.
Montelaro teaches compositions according to claim 1, wherein the composition comprises a surfactant (Montelaro, e.g., 0111), but does not expressly teach polysorbate 80.
However, polysorbate 80 was known and used in similar peptide compositions as evident from Constantino. Constantino teaches polysorbate 80 was useful in similar peptide containing compositions in combination with a buffer for nasal and/or pulmonary delivery (Constantino, e.g., 0247). Constantino suggests polysorbate 80 useful for surface active properties and to reduce local reactions to active agents (Constantino, e.g., 0016, and 0065).
It would have been obvious before the effective filing date of the presently claimed invention to modify compositions comprising a peptide which has a sequence identity with SEQ ID NO:14 within the scope of claim 1 by including polysorbate 80 as a surface-active agent with a reasonable expectation of success. Since Montelaro teaches formulating the peptide in pharmaceutical compositions with a buffer, surfactant, and carrier, wherein the composition may be formulated for nasal or pulmonary delivery, the skilled artisan would have been motivated to use a known surface-active agent such as polysorbates 80 to reduce local reaction while selecting a surfactant which is suitable for the administration routes outlined in Montelaro with a reasonable expectation of success.
Accordingly, the subject matter of claims 1-16 and 21 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 1-8, 10-14, 16, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Montelaro, US 20090099533 A1 in view of Honglei, US 20180193537 A1.
Montelaro teaches a coating composition according to claim 1, wherein the coating composition is for coating a medical device but does not expressly teach the form of a film.
However, Honglei teaches antibiotic composition in the form of a film for coating an implantable medical device (Honglei, e.g., Abstract, 0081-0084, 0155, 0164, 0178, claim 38). The film form offers reduced fragility, greater antibiotic stability, independent tuning of antibiotic release, secure attachment to a variety of sizes of medical devices, and reduced device migration (Honglei, e.g., 0174-0178).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify coating compositions of Montelaro into the form of a film as suggested by Honglei with a reasonable expectation of success. The skilled artisan would have been motivated to make this modification for the improved film benefits explained in Honglei. The skilled artisan would have had a reasonable expectation of success because each document teaches antimicrobial coating compositions for medical devices.
Accordingly, the subject matter of claims 1-8, 10-14, 16, and 21-22 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A WAX can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615
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