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 .
Status of the Claims
Claims 6, 8, 14-16, 18-19, 21-28, 30-32, 34-35, 37-51, and 53-54 have been canceled.
Claims 1-5, 7, 9-13, 17, 20, 29, 33, 36, 52, and 55-57 are currently pending.
Election/Restrictions
Applicant’s election with traverse of Group I, Claims 1-5, 7 and 9-13, and of species post-implantation infections associated with infection of tissues around a medical device implanted in the body or of a medical device implanted in the body, β-1,3-endoglucanase, and a gel, in the reply filed on 12/31/2025 is acknowledged. The traversal is on the ground(s) that the Groups do make a contribution over the prior art. This is not found persuasive because as indicated by the rejections below, the groups do not share the special technical feature which contributes over the prior art at the time the invention was made.
The requirement is still deemed proper and is therefore made FINAL.
Claims 2, 4-5, 9-12, 17, 20, 29, 33, 36, 52, and 55-57 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions and species, there being no allowable generic or linking claims.
Claims 1, 3, 7, and 13 are being examined in this application, insofar as they read on the elected species of post-implantation infections associated with infection of tissues around a medical device implanted in the body or of a medical device implanted in the body, β-1,3-endoglucanase, and a gel.
Claim Rejections – 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 1, 3, 7, and 13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating bacterial infections involving biofilm formation by administering the claimed composition, does not reasonably provide enablement for a method of preventing bacterial infections involving biofilm formation instantly claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is undue. These factors include, but are not limited to: (a) breadth of the claims; (b) nature of the invention; (c) state of the prior art; (d) level of one of ordinary skill in the art; (e) level of predictability in the art; (f) amount of direction provided by the inventor; (g) existence of working examples; and (h) quantity of experimentation needed to make or use the invention based on the content of the disclosure. (See Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988).
The above factors, regarding the present invention, are summarized as follows:
The breadth of the claims – The breadth of the claims is drawn to a method of treating bacterial infections involving biofilm formation by administering a composition comprising endoribonuclease enzymes.
The Nature of the invention – The nature of the invention is drawn to the administration of a composition comprising endoribonuclease enzymes for treating bacterial infections involving biofilm formation.
The state of the prior art / The predictability or lack thereof in the art – The state of the prior art is that the pharmacological art involves screening in vitro and in vivo of the selected composition to determine the desired pharmacological activities (i.e. what compositions can treat which specific disease by what mechanism). There is no absolute predictability even in view of the seemingly high level of skill in the art. The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any therapeutic regimen on its face.
“Prevention” provides the expectation that the diseases/disorders or conditions do not occur in response to a challenge or initiating event. While there is no requirement that prevention must be absolute in all cases, there is a reasonable expectation that some element of prevention can be shown. The standard for such is extremely high, and it is expected that the showing will be actual rather than implied, prophetic, or with a model. The standard of enablement is higher for such inventions because effective preventions of disease conditions are relatively rare and may even be unbelievable in the absence of strong supporting evidence.
With respect to Applicant’s claims to prevention, there are no known compositions that have been demonstrated to prevent bacterial infections involving biofilm formation instantly claimed.
The relative skill of those in the art – The relative skill of those in the art is high, with a typical practitioner possessing commensurate degree level, as well as several years of professional experience.
The amount of direction or guidance present – There is no direction or guidance present for the prevention of bacterial infections involving biofilm formation by administering the instant composition.
Examples provided in the specification demonstrate efficacy of enzyme compositions to reduce biofilms involved in infections, however, the disclosure does not provide how the in vivo data correlates to the prevention of bacterial infections involving biofilm formation of the instant claims.
The presence or absence of working examples – The working examples present in the instant specification are directed to evaluating the efficacy of enzyme compositions against biofilms.
With respect to the prevention of bacterial infections involving biofilm formation, there is no evidence of record, which would enable the skilled artisan in the identification of the subjects who have the potential of becoming afflicted with the numerous bacterial infections claimed herein. That a single composition can be used to prevent all bacterial infections embraced by the claims is an incredible finding for which Applicant has not provided supporting evidence. Applicant has not provided any competent evidence or disclosed tests that are highly predictive for the pharmaceutical use for preventing any or all of bacterial infections by administering the instant claimed composition.
The quantity of experimentation needed – The quantity of experimentation needed is undue experimentation. One of ordinary skill in the art would need to determine which patients not having particular bacterial infections would otherwise develop them and administer the instant composition over such an extended period of time as to determine true prevention. Such a task has yet to be accomplished in the art and the instant specification provides no particular guidance on how to accomplish such a task.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. {In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)}.
Genetech, 108 F.3d at 1366, states that, “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion.” And “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.”
Therefore, in view of the Wands factors discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test which bacterial infections can be prevented by the composition encompassed in the instant claims, with no assurance of success.
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 7 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 pre-AIA the applicant regards as the invention.
Claim 7, line 3, the recitation of “preferably” is indefinite as it is unclear if the limitation that follows is required to meet the scope of the invention.
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 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, 3 and 13 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Jain (US 9,867,871 B2; 1/16/2018.).
The instant claims recite a method of treatment with a parapharmaceutical or pharmaceutical composition, the parapharmaceutical or pharmaceutical composition comprising at least one endoribonuclease enzyme selected from the group consisting of enzymes belonging to the enzyme classes EC 3.1.30 and EC 3.1.31 and mixtures thereof, to potentiate a microbicidal agent, comprising an antibiotic, an antifungal, or a disinfectant, the method comprising administering a therapeutically effective dose of the parapharmaceutical or pharmaceutical composition to human beings in the treatment and/or the prevention of bacterial infections involving biofilm formation.
Jain teaches a composition and a method for treating nucleic acid-related eye disease (Abstract), comprising administering a therapeutically effective dose of a nuclease composition to a human suffering from said disease (col.10 line 33-35; col.13 line 16-18, 36, 40-43, 45-48), said disease may be caused by biofilm that may form on materials that come in contact with the eye such as materials implanted in the eye (col.14 line 10-12, 62, 65-66), the nuclease composition comprises micrococcal nuclease (EC 3.1.31.1) (col.7 line 24), and an antibiotic compound (col.6 line 49). The nuclease composition may be in the form of a gel or a film (col.11 line 45; col.12 line 42-43).
Therefore the reference anticipates the claimed subject matter.
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.
Claims 1, 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Siala et al (US 2019/0192639 A1; 6/27/2019.) in view of Jain (US 9,867,871 B2; 1/16/2018.).
The instant claims recite a method of treatment with a parapharmaceutical or pharmaceutical composition, the parapharmaceutical or pharmaceutical composition comprising at least one endoribonuclease enzyme selected from the group consisting of enzymes belonging to the enzyme classes EC 3.1.30 and EC 3.1.31 and mixtures thereof, to potentiate a microbicidal agent, comprising an antibiotic, an antifungal, or a disinfectant, the method comprising administering a therapeutically effective dose of the parapharmaceutical or pharmaceutical composition to human beings in the treatment and/or the prevention of bacterial infections involving biofilm formation.
Siala teaches a method for treating, at an implantation site, post-implantation infections (para 0026) of mammalian bodies, in particular of the human body, with a composition comprising at least one enzyme and at least one microbicidal molecule (para 0052), comprising: administering, at an implantation site of an implantable medical device, of a composition comprising at least one enzyme and at least one microbicidal molecule (para 0053), breakdown, by action of said at least one enzyme of said administered composition, of a biofilm present at said implantation site of said implantable medical device (para 0054), and destruction of bacteria and/or inhibition of the growth of bacteria released from said biofilm, by action of said at least one microbicidal molecule of said administered composition (para 0055), wherein the at least one enzyme includes deoxyribonucleases (DNases) (para 0037) and is supplied in a concentration between 0.01 and 1000 mg/L (para 0039), the at least one microbicidal molecule includes antibiotic (para 0027) and is supplied in a concentration between 0.01 and 1000 mg/L (para 0041). The administration may be carried out by means of a gel, ointment, cream or via a patch (para 0050, 0056).
Siala does not teach the method wherein the at least one enzyme includes enzymes belonging to the enzyme classes EC 3.1.30 and/or EC 3.1.31 (claim 1).
However, Siala does teach the method comprising a nuclease composition comprises at least one enzyme. Jain teaches a nuclease composition comprises micrococcal nuclease (EC 3.1.31.1) (col.7 line 24), and an antibiotic compound (col.6 line 49), wherein the nuclease composition is useful for treating a disease that may be caused by biofilm (col.14 line 10, 61-62).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate enzymes belonging to the enzyme class EC 3.1.31, since Siala and Jain both disclose a nuclease composition useful for treating a condition that may be caused by biofilm, and Jain discloses the nuclease composition comprises micrococcal nuclease (EC 3.1.31.1). Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to incorporate enzymes belonging to the enzyme class EC 3.1.31, with a reasonable expectation for successfully treating, at an implantation site, post-implantation infections of mammalian bodies, in particular of the human body.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Siala et al (US 2019/0192639 A1; 6/27/2019.) in view of Jain (US 9,867,871 B2; 1/16/2018.) as applied to claims 1, 3 and 13, further in view of Tan et al (International Journal of Biological Macromolecules. 2018;108:942-946.).
References cited above do not teach the method comprises a second enzyme including β-1,3-endoglucanase (claim 7).
However, Siala does teach the method for treating infections comprising a composition comprises at least one enzyme, wherein the infections may be caused by Candida albicans (forms biofilms) (para 0047). Tan teaches disrupting biofilm and increasing the drug killing affection through degrading the matrix is a potential method for treatment of biofilm related infections (p.944 col right – last para), and β-1,3-glucanase is proposed as antibiofilm agent that can treat Candida biofilm related infections by degrading the biofilm extracellular matrix (Abstract, p.946 col left – para 2).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate β-1,3-glucanase, since Siala discloses a method for treating infections that may be caused by Candida albicans comprises at least one enzyme, and Tan discloses that β-1,3-glucanase may be useful as an antibiofilm agent. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to incorporate β-1,3-glucanase with a reasonable expectation for successfully treating, at an implantation site, post-implantation infections of mammalian bodies, in particular of the human body.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 3, 7, and 13 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 1 of U.S. Patent No 12,364,738 B2 (referred to as the ‘738 patent) in view of Jain (US 9,867,871 B2; 1/16/2018.) and Tan et al (International Journal of Biological Macromolecules. 2018;108:942-946.).
Claim 1 of the ‘738 patent recites a method of treatment for post-implantation infections of mammalian bodies, the method comprising: administering a therapeutically effective amount of a composition comprising a combination of an enzymatic cocktail; and a fluoroquinolone microbicidal molecule (antibiotic), wherein the composition is effective to reduce by at least 1 Log 10 the number of viable bacteria in biofilms formed post-implantation to a mammalian body following implantation of an implantable medical device.
‘738 patent does not teach the enzymatic cocktail includes enzymes belonging to the enzyme classes EC 3.1.30 and/or EC 3.1.31 (claim 1), and an application of a gel (claim 13).
Jain teaches a composition and a method for treating a disease (Abstract) that may be caused by biofilm (col.14 line 10-12, 62, 65-66), comprising administering a therapeutically effective dose of a nuclease composition to a human suffering from said disease (col.10 line 33-35; col.13 line 16-18, 36, 40-43, 45-48), wherein the nuclease composition comprises micrococcal nuclease (EC 3.1.31.1) (col.7 line 24), and an antibiotic compound (col.6 line 49). The nuclease composition may be in the form of a gel or a film (col.11 line 45; col.12 line 42-43).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate enzymes belonging to the enzyme class EC 3.1.31, since ‘738 patent discloses a method of treating a condition caused by biofilm comprises administering enzymes, and Jain discloses a nuclease composition useful for treating a condition that may be caused by biofilm where the nuclease composition comprises micrococcal nuclease (EC 3.1.31.1). Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to incorporate enzymes belonging to the enzyme class EC 3.1.31, with a reasonable expectation for successfully treating post-implantation infections of mammalian bodies.
References cited above do not teach the method comprises a second enzyme including β-1,3-endoglucanase (claim 7).
Tan teaches disrupting biofilm and increasing the drug killing affection through degrading the matrix is a potential method for treatment of biofilm related infections (p.944 col right – last para), and β-1,3-glucanase is proposed as antibiofilm agent that can treat biofilm related infections by degrading the biofilm extracellular matrix (Abstract, p.946 col left – para 2).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate β-1,3-glucanase, since ‘738 patent discloses a method of treating a condition caused by biofilm comprises administering enzymes, and Tan discloses that β-1,3-glucanase may be useful as an antibiofilm agent. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to incorporate β-1,3-glucanase with a reasonable expectation for successfully treating post-implantation infections of mammalian bodies.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759