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 1-20 are currently pending.
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-19, and of species bromelain (first protease), ficain (second protease), actinidain (third protease), asclepain (fourth protease), and Interleukin-1β (protein), in the reply filed on 1/2/2026 is acknowledged.
Claim 20 has been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions and species, there being no allowable generic or linking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 1-19 are being examined in this application, insofar as they read on the elected species of bromelain (first protease), ficain (second protease), actinidain (third protease), asclepain (fourth protease), and Interleukin-1β (protein).
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 1, 3-5, 7-9, 11-13, and 15-19 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 1 (line 6), 5 (line 6), 9 (line 5), and 13 (line 6), the recitation of “a prescribed period of time” is indefinite. The instant specification does not provide a definition for the phrase, and the plain meaning of the phrase is a specific period of time that has been determined or agreed upon beforehand. There are many kinds of proteases that exhibit different activities, it is unclear what is the claimed prescribed period of time that works with any proteases used to treat an area of skin.
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 17-19 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Kling et al (US 2015/0297687 A1; 10/22/2015.).
The instant claims recite a method to promote tissue repair and wound healing, the method comprising: applying a protease composition to an area of skin; wherein the protease composition comprises one or more proteases; modulating, by the protease composition, at least one of a wound-related protein or an inflammation-related protein; and treating the area of skin for a prescribed period of time.
Kling teaches a method for modulating the protein profile of a tissue or its surrounding environment to promote the repair of a damaged tissue, or one that is otherwise compromised by disease or injury, by administering a composition containing proteases to the affected area (para 0013), wherein the protease can modulate the action or level of at least one protein, and said protein is a wound-related protein or an inflammation-related protein (para 0014). Said proteases promote wound healing and prevent or treat skin problems (para 0038). Said proteases include bromelain, ficain, actinidain, and asclepain (para 0032). Wound-related protein include Interleukin-1β (IL-β) (para 0018). Inflammation-related protein include IL-β (para 0019). Administration of the composition comprises proteases diminishes the rate of itching (para 0021). Said proteases can be formulated into a therapeutic composition including a solution, a skin covering or dressing that provide slow or timed release of the proteases into a wound (treating the area of skin for a prescribed period of time) (para 0039).
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 4-5, 7-9, 11-13, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kling et al (US 2015/0297687 A1; 10/22/2015.) as applied to claims 1, 3 and 17-19 above, further in view of Schultz et al (Wounds International. 2017;1-6.).
Kling does not teach the claimed concentration (claims 4, 8, 12, and 16), the second protease composition including ficain (claims 5 & 7), the third protease composition including actinidain (claims 9 & 11), and the fourth protease composition including asclepain (claims 13 & 15).
However, Kling does teach the method wherein said proteases include ficain, actinidain, and asclepain (para 0032), the proteases can be formulated into a therapeutic composition including a solution (para 0039), the proteases form about 1.0% to about 10% by weight of the composition, the amount of the proteases required for healthy skin development or wound treatment will vary not only with the route of administration, but also the nature of the condition being treated and the age and condition of the patient and will be ultimately at the discretion of the attendant physician or clinician (para 0040). Kling teaches by varying the type and amount of proteases applied, the degree of protein degradation and consequently inhibition can be controlled (para 0024), one of skill in the art can choose an appropriate protease or combination of proteases to achieve the quality and quantity of modulation desired, the type and quantity of proteases used determines the level of inhibitory and/or activation modulatory effects on the target proteins, one of skill in the art can readily make modifications to the protease mixtures and observe the type and degree to which a given protein is inhibited (para 0025), and depending on the wound etiology, the patient immune system and the tissue trauma, various formulations could be developed in order to provide an optimal protein and enzyme activation and inactivation ratios specific for the disease (para 0038).
Schultz teaches at each of the physiological stages of normal wound healing, controlled proteases are necessary for wound healing, these proteases must always be present in the right places, at the right times and at the right levels (p.2 col left – para 2). Schultz teaches elevated levels of active proteases and excessive protease activity greatly reduce the probability of healing unless appropriate interventions are in place (p.2 col right – para 1, p.3 col right – last para).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to apply a second, third and fourth protease compositions comprise at least one protease to a skin area, since Kling discloses applying proteases to a skin area to promote tissue repair and wound healing, a skill in the art can choose an appropriate protease or combination of proteases to achieve the quality and quantity of modulation desired, various formulations could be developed in order to provide an optimal protein and enzyme activation and inactivation ratios specific for the disease, and Schultz discloses elevated levels of active proteases and excessive protease activity greatly reduce the probability of healing, and proteases must always be present in the right places, at the right times and at the right levels. In other words, one of skill in the art would apply specific proteases at a time to target different proteins depending on the disease conditions and to better control the level of protease activity to promote tissue repair and wound healing. In addition, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to optimize the concentration of proteases in a solution, since Kling discloses the proteases form about 1.0% to about 10% by weight of the composition, and the dosage vary depending upon the location of the skin or tissue to be treated and/or upon severity of the wound. Generally, differences in concentration will not support patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. (MPEP 2144.05 II) 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 apply a second, third and fourth protease compositions comprise an optimized amount of at least one protease to a skin area with a reasonable expectation for successfully modulating the protein profile of a tissue or its surrounding environment to promote the repair of a damaged tissue, or one that is otherwise compromised by disease or injury.
Claims 2, 6, 10, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kling et al (US 2015/0297687 A1; 10/22/2015.) as applied to claims 1, 3 and 17-19 above, further in view of Schmalz (https://awakeninghealth.ca/physiological-effects-of-inflammation. 2022;1-2.).
References cited above do not teach the claimed prescribed period of time (claims 2, 6, 10, and 14).
However, Kling does teach the method wherein the proteases are useful for the treatment of wounds and skin conditions such as inflammation (para 0021).
Schmalz teaches a typical inflammatory response last 48-72 hours (p.1 para 3).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to treat an area of skin for a prescribed period of time that is in a range of 6 to 72 hours, since Schmalz discloses that a typical inflammatory response last 48-72 hours, and Kling discloses a method comprises proteases that are useful for treating inflammation. 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 treat an area of skin for a prescribed period of time that is in a range of 6 to 72 hours with a reasonable expectation of success.
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