DETAILED ACTION
Claims 1-20 are pending in the instant application.
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 .
Priority
The instant application claims priority to the U.S. Provisional Application Serial No. 63/593,307 filed October 26, 2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement was considered by the examiner. Please see attached initialed Forms 1449.
Claim Objections
Claim 19 is objected to because of the following informalities: ‘using to the article’ is a typing error. It should be ‘using the article’. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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 18-20 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.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.' " (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
The instant claims are drawn to preventing a bacterial infection or a periodontal disease or formation of biofilm in a subject. The specification fails to define “prevent” or “prevention”. Examiner therefore interprets the term to mean that infection will ever occur in the patient.
The quantity of experimentation required to practice this method would be immense. A statistically significant number of subjects would be needed to receive the article of claim 1, then the symptoms of each of the large number of bacterial infections would have to be evaluated for the remainder of the subjects’ lives to see if any of them develop. If symptoms appear then there will have been no prevention.
The specification provides inadequate guidance to allow the one skilled in the art to determine how to evaluate whether prevention had occurred - what clinical signs, markers, or lab values would qualify as preventing a bacterial infection or a periodontal disease or formation of biofilm?
The specification provides no working examples to show how a prevention would have occurred.
The nature of the invention is the use of a nitric oxide releasing compound to treat a bacterial infection.
The state of the prior art is that Brisboi discloses using a nitric oxide releasing compound to kill bacteria as detailed below in the rejection under 35 USC 103.
The relative skill of one of ordinary skill in this art would be quite high, for example, a medical doctor or a doctor of dentistry accustomed to determining bacterial infections.
The predictability of whether an article can prevent any of the listed conditions is very low for the reasons detailed above.
Finally, the claims are broad that an article can comprise a polymer and any nitric oxide releasing compound.
Thus, based on the analysis above the conclusion that the instant claims are not enabled is inescapable.
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 5 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. “Second first polyethylene glycol” is indefinite.
Claims 18-20 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. A process without setting forth any steps involved in the process is indefinite.
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 1-2, 6, 10-14, 16 and 20 are rejected under 35 U.S.C. 102(a)(1)(a)(2) as being anticipated by Brisbois et al. (US 11103622 B2).
Brisbois discloses a novel S-nitrosothiols (RNSO) polymer formulation useful for making biomedical devices (col 3, lines 32-35). Examples of the present disclosure are novel nitric oxide (NO) releasing coatings formed from polymers doped with S-nitroso-N-acetylpenicillamine (SNAP) (col 4, lines 46-48). Incorporations of RNSOs into polymers can extend the utility of these NO donors to be applicable as coatings in biomedical devices, providing localized NO release at the blood/device interface. Several NO-release polymers include polyethylene glycol (PEG) (col 7, lines 4-10). Nitric oxide is known to kill bacteria and prevent biofilm formation (col 6, lines 30-32).
An article comprising a polymer and a nitric oxide releasing compound is anticipated By Brisbois.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Brisbois et al. (US 11103622 B2) and Handa et al. (US 2021/0061817 A1) further evidenced by Johnston et al. (Mechanical biofilm disruption causes microbial and immunological shifts in periodontitis patients, scientific reports, 2021).
Brisbois discloses a novel S-nitrosothiols (RNSO) polymer formulation useful for making biomedical devices (col 3, lines 32-35). Examples of the present disclosure are novel nitric oxide (NO) releasing coatings formed from polymers doped with S-nitroso-N-acetylpenicillamine (SNAP) (col 4, lines 46-48). Incorporations of RNSOs into polymers can extend the utility of these NO donors to be applicable as coatings in biomedical devices, providing localized NO release at the blood/device interface. Several NO-release polymers include polyethylene glycol (PEG) (col 7, lines 4-10). Nitric oxide is known to kill bacteria and prevent biofilm formation (col 6, lines 30-32).
Brisbois does not explicitly mention SNAP covalently attached to ampicillin.
Handa discloses modified antibiotic compounds; the compound comprises a nitric oxide release agent covalently attached to an antibiotic molecule, such as S-nitroso-N-acetylpenicillamine covalently attached to ampicillin (Abstract).
Therefore, it would have been obvious to one of ordinary person in the art before the effective filing date of the claimed invention to have combined teachings of above to arrive at an article comprising a polymer and a nitric oxide releasing compound covalently attached to ampicillin. This is taking some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Regarding claim 2, PEG is taught above.
Regarding claims 3-5, one of ordinary skill in the art would routinely experiment with various PEG polymers to coat the nitric oxide releasing compound. As Brisbois disclosed above, incorporations of RNSOs into polymers can extend the utility of these NO donors to be applicable as coatings in biomedical devices, providing localized NO release at the blood/device interface. The advantages and motivation for doing so is clear.
Regarding claim 6, Brisbois discloses that RSNO can be bound to polymers (col 5, lines 5-10).
Regarding claims 7-9, SNAP being bound to an antibiotic such as ampicillin is taught above.
Regarding claim 10, nitric oxide releasing compound, S-nitrosothiol is taught above.
Regarding claims 11-12, S-nitroso-N-acetylpenicillamine is taught above.
Regarding claim 13, Brisbois discloses a catheter tubing coated with an active layer of 5 wt % or 10 wt % SNAP/E2As followed by a top coat of E2As (Col 3, line 13-15).
Regarding claim 14, composition further comprising an antibiotic is taught by Handa above.
Regarding claim 15, Brisbois discloses dissolving polymer in solvent. Then adding SNAP to the polymer and solvent mixture, followed by stirring (col 16, lines 12-20). A composition comprising a polymer and a nitric oxide releasing compound can be produced in various other ways including the optional heating step. The end product would still be a composition comprising a polymer and a nitric oxide releasing compound.
Regarding claim 16, medical device is taught above.
Regarding claim 17, nitric oxide is routinely used to kill bacteria and prevent biofilm formation as taught by Brisbois above. One of ordinary skill in the art would immediately envisage that a compound known to kill bacteria and biofilm would be useful in areas that have such bacteria and biofilm, including an oral cavity.
Regarding claim 18, if an oral cavity houses bacteria, a compound known to reduce or kill bacteria would generally be useful for such a purpose regardless of the location of bacteria.
Regarding claim 19, Johnston discloses that periodontitis is a highly prevalent, biofilm-mediated chronic oral inflammatory condition affecting 50% of the population. PD arises via the formation of dysbiotic subgingival plaque biofilms (pg 1). A compound known to kill biofilm would be helpful in biofilm-caused conditions such as periodontitis.
Regarding claim 20, nitric oxide releasing compound is known to reduce the formation of biofilm.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of copending Application No. 19/597,885 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both applications claim a nitric oxide releasing composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN SEUNGJAI KWON whose telephone number is (571)272-7737. The examiner can normally be reached Mon - Fri 8:00 - 5:00.
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/JOHN SEUNGJAI KWON/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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