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 of claims 10-20 drawn to a method for debridement and promoting granulation tissue formation of a chronic wound in the reply filed on 14 June 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Claims 1-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected composition, there being no allowable generic or linking claim.
CLAIMS UNDER EXAMINATION
Claims 10-20 have been examined on their merits.
PRIORITY
Provisional Application 62323812, filed on 18 April 2016, is acknowledged. It does not provide support for a composition which “does not contain therapeutically effective amounts of amylase enzymes”. The earliest support for this limitation is the specification field on 07 May 2024 (see ([0060]).
REJECTIONS
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 20 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.
Claim 20 recites the composition does not contain “therapeutically effective amounts of amylase enzymes”. The specification does not define or disclose what amounts are therapeutically effective. It is unclear what amounts are allowed or excluded by the claim. The metes and bounds of the claim are unclear. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 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 10-20 are rejected under 35 U.S.C. 103 as being unpatentable over Salamone et al. (Compositions And Kits For Enzymatic Debridement And Methods Of Using The Same. US2016/0101165 A1 14 April 2016) in view of Fallon et al. (Enzyme Compositions and use thereof for wound healing. US 2022/0096611 A1 with benefit of 13/757412, filed on 2013 February 1) and Agro Gums et al. (Pharmaceutical Applications of Guar Gum. 2013. Pages 1-6)
Salamone teaches compositions and methods for enzymatic debridement of chronic wounds (Abstract; [0105]). Bromelain is a group of proteolytic enzymes from the stem of pineapple plants ([0003]). The art discloses compositions comprising bromelain ([0133]; Table 8; Table 10). The art teaches lyophilization as a powder to produce a gel ([0042]).
The formulation can be administered topically ([0118]).
Guar gum is a “viscosity builder” which can be used in the composition ([0044]). Viscosity builders can be present in an amount from 1.0% to 10% by weight ([0045]).The art identifies water as an excipient ([0040] [0092]). Salmone teaches adding a water-soluble polymer can be added to increase solution viscosity and to prolong residence time of the enzymatic composition on the necrotic tissue, on the surface of a wound, or subcutaneously in a wound ([0052]).
Salamone teaches the use of a “buffering agent” (a pH adjusting agent; see claim 20 of Salamone). Salamone teaches a pH in the range from 5.5 to 7.5.(about 6 to about 8; [0045]).
Salamone discloses a kit that includes the debridement composition and instructions
([0102]). The instructions can include contacting the debridement composition with an
area of skin in need of debridement. The instructions can include repeating the
contacting step at regular intervals ([0102]). In a specific embodiment, Salamone treats for “24 hours” ([0156]).
Instant claim 10 requires proteins in the composition be present in 1-7% (w/w). The PG Pub of the specification discloses “the proteolytic enzyme mixture is denoted throughout the specification and claims as the active principal ingredient (API)…. the amount of proteins, or alternatively the amount of API (PG Pub [0166]). Therefore claim 1 is interpreted to mean the proteolytic enzyme mixture is present in a range of 1-7% (w/w).
Salamone teaches the composition can include “up to 10% by weight of proteolytic enzyme” ([0028]). A specific embodiment teaches 10% bromelain (see Tables 9 and 10).
Salamone does not explicitly teach the claimed enzyme range.
Salamone does not teach guar gum with sufficient specificity to anticipate the claim.
Salamone does not teach an anti-aggregation agent.
Agro Gums teaches guar gum is used as a thickening agent and stabilizing agent (see page 1, first paragraph). It is preferred for applications where gelling, viscosifying or thickening is the primary requirement (see page 2, second paragraph).
Guar gum has high molecular weight and therefore has the ability to produce highly viscous solutions even at lower concentrations. This property of guar gum gives it the required solubility and ability to form gels even in cold water (see page 1, second paragraph). Guar gum has high hydration rate which mean it can swell fast in aqueous solutions and therefore is used in the production of therapeutical formulations to forms gels and viscous dispersions (see page 2, first paragraph).
Fallon et al. disclose compositions and methods of using enzymatic compositions for wound healing (Abstract). The composition can be topical, and may be used to treat chronic wounds ([0013] [0137]). The composition can contain bromelain (from pineapple) ([0092] [0093]). The art teaches as a gel ([0012] [0120]). The art teaches a potassium phosphate as a buffer and a neutral pH ([0139]). Fallon teaches preparing a lyophilized powder that is reconstituted as a gel ([0138]). The powder is prepared by dissolving enzymes in a suitable solvent containing an excipient which improves the stability of the powder or reconstituted solution, prepared from the powder. Excipients that may be used include glucose or sucrose ([0139]). As evidenced by the PG Pub of the instant specification, these are anti-aggregation agents ([0054]).
It would have been obvious to optimize the amount of bromelain used in the Salamone’s composition. Salamone teaches the enzymes in bromelain debride a wound. The skilled artisan would optimize the amount based on the desired level of debridement. One would have had a reasonable expectation of success using less than the 10% taught in the specific embedment taught by Salamone since the art teaches the composition can include “up to 10% by weight of proteolytic enzyme”.
It would have been obvious to use an anti-aggregation agent in the powder taught by
Salamone. Salamone teaches a lyophilized composition and Fallon teaches adding anti-aggregation agents in lyophilized compositions. One would have been motivated to do so to improve the stability of the lyophilized composition, as taught by Fallon.
One would have had a reasonable expectation of success since Fallon teaches anti-aggregation agents can successfully be used in lyophilized preparations comprising bromelain. One would have expected similar results since Salamone and Fallon are both directed to lyophilized compositions formulated as gels.
It would have been obvious to use guar gum as the viscosity builder in the method
taught by Salamone. Salamone identifies guar gum as a viscosifying agent. See KSR Rationale E (MPEP 2143 Rationale E). While Salamone discloses other viscosity building agents, motivation to use guar gum specifically is provided by Agro Gums, which teaches 1) guar gum is widely preferred for its viscosity increasing properties 2) has a high hydration rate which mean it can swell fast in aqueous solutions and 3) is used in the production of therapeutic formulations to forms gels and viscous dispersions. One would have had a reasonable expectation of success since Salamone teaches it can be used in the disclosed method of treatment. One would have expected similar results since both references are directed to viscosifying agents.
It would have been obvious to use 2.6% to 3.5% guar gum in the composition taught by Salamone. One would have been motivated to do so since Salamone teaches viscosity building agents can be used at a concentration between 1-10% by weight. Salamone teaches water-soluble polymers are used in gels to increase solution viscosity and prolong residence time of the enzymatic composition on the necrotic tissue, on the surface of a wound, or subcutaneously in a wound. The skilled artisan would optimize within the range taught by Salamone to obtain a gel with the desired residence time on a wound. Because the claimed amount of viscosifying agent (guar gum) is rendered obvious, it would be expected to produce a composition with the claimed viscosity. See MPEP 2133.03 and MPEP 2144.05. Therefore claims 10-11 are rendered obvious.
Salamone teaches treating a pressure ulcer or a diabetic ulcer [0054]). Claim 12 is rejected.
Salamone teaches administration for 24 hours (supra). Claim 13 is rejected.
Regarding claims 14 and 16: Salamone teaches the enzymatic debridement composition can be applied to the devitalized tissue as needed to dissolve necrotic debris in and around a wound ([0053]). The enzymatic debridement composition can be in contact with the devitalized tissue for 24 hours ([0053] [0156]). The contacting can occur at regular intervals, including at least once a day ([0102]). Salamone does not explicitly three applications per week.
It would have been obvious to administer three applications per week for about 24 hours. Salamone teaches daily administration and teaches doing so at regular intervals as needed. The skilled artisan would repeat application until the desired level of debridement is achieved. One would have had a reasonable expectation of success since Salamone teaches the composition can be administered as needed. Therefore claim 14 is rendered obvious.
It would have been obvious to administer up to 10 applications during a period 1 to 3 weeks. Salamone teaches daily administration and teaches doing so at regular intervals as needed. The skilled artisan would repeat application until the desired level of debridement is achieved. One would have had a reasonable expectation of success since Salamone teaches the composition can be administered as needed. Therefore claim 16 is rendered obvious.
Salamone teaches administration as needed (supra). Claim 15 is rejected.
Regarding claims 17-18: claimed composition is rendered obvious. Therefore it would be expected to meet the limitations recited in claims 17-18.
Regarding claim 19: The teachings of Salamone and Agro Gums are reiterated. Salamone teaches a gel formulation ([0040]) can contain up to 99.9% excipient ([0040]). Salamone teaches an excipient is a substance that disperses an enzyme or other added ingredients ([0092]). Salamone teaches a buffer ranging in pH from 5.0-7.5 ([0041]). Salamone identifies buffers as carriers, and teaches up to 99.9% ([0040] see DPBS in Table 2).
Salamone does not explicitly teach 5% protease enzymes. The art does not teach lactose, sucrose, mannitol, trehalose or glucose as anti-aggregation agents. The art does not teach potassium phosphate as a pH adjusting agent.
Fallon et al. teaches potassium phosphate to achieve a neutral pH ([0139]).
Fallon teaches gels are formulated with excipients ([0124]). Mannitol, glucose and sucrose are excipients ([0125][0139]).
It would have been obvious to optimize the amount of bromelain used in the Salamone’s composition. Salamone teaches the enzymes in bromelain debride a wound. The skilled artisan would optimize the amount based on the desired level of debridement. One would have had a reasonable expectation of success using less than the 10% taught in the specific embedment taught by Salamone since the art teaches the composition can include “up to 10% by weight of proteolytic enzyme”.
It would have been obvious to use potassium phosphate as a buffer. One would have
been motivated to do so since Salamone prepares a lyophilized enzyme composition
and Fallon teaches the use of potassium phosphate buffers when lyophilizing enzyme
compositions. Salamone teaches using a buffering agent to provide a pH of 7.4. One would optimize the amount of buffer used to achieve the pH taught by Salamone. One would have had a reasonable expectation of success since Fallon teaches potassium phosphate buffers can be used in enzymatic debridement compositions. One would have expected similar results since Salamone and Fallon are both directed to compositions comprising bromelain.
It would have been obvious to use sucrose, glucose or mannitol in the composition taught by Salamone. Salamone teaches a lyophilized composition and Fallon teaches adding anti-aggregation agents in lyophilized compositions. One would have been motivated to do so to improve the stability of the lyophilized composition, as taught by Fallon. One would have had a reasonable expectation of success since Fallon teaches anti-aggregation agents can successfully be used in lyophilized preparations comprising bromelain. One would have expected similar results since Salamone and Fallon are both directed to lyophilized compositions formulated as gels.
It would have been obvious to use 3.5% guar gum. One would have been motivated to do so since Salamone teaches viscosity building agents can be used at a concentration between 1-10% by weight. Salamone teaches water-soluble polymers are used in gels to increase solution viscosity and prolong residence time of the enzymatic composition on the necrotic tissue, on the surface of a wound, or subcutaneously in a wound. The skilled artisan would optimize within the range taught by Salamone to obtain a gel with the desired residence time on a wound. Because the claimed amount of viscosifying agent (guar gum) is rendered obvious, it would be expected to produce a composition with the claimed viscosity. See MPEP 2133.03 and MPEP 2144.05. Therefore claim 19 is rendered obvious.
Regarding claim 20: the teachings of Salamone are reiterated. It is noted the art teaches compositions which do not require any amylase are able to debride a wound (see Table 7 and 9). The formulation in Table 9 contains bromelain in antibiotic (an antibacterial agent). Salamone does not teach guar gum with sufficient specificity. The art does not teach the claimed range of protease enzyme. Salamone does not explicitly teach an anti-aggregation agent. The art does not teach the claimed viscosity.
The teachings of Agro Gums and Fallon are reiterated.
It would have been obvious to optimize the amount of bromelain used in the Salamone’s composition. Salamone teaches the enzymes in bromelain debride a wound. The skilled artisan would optimize the amount based on the desired level of debridement. One would have had a reasonable expectation of success using less than the 10% taught in the specific embedment taught by Salamone since the art teaches the composition can include “up to 10% by weight of proteolytic enzyme”.
It would have been obvious to use an anti-aggregation agent in the powder taught by
Salamone. Salamone teaches a lyophilized composition and Fallon teaches adding anti-aggregation agents in lyophilized compositions. One would have been motivated to do so to improve the stability of the lyophilized composition, as taught by Fallon.
One would have had a reasonable expectation of success since Fallon teaches anti-aggregation agents can successfully be used in lyophilized preparations comprising bromelain. One would have expected similar results since Salamone and Fallon are both directed to lyophilized compositions formulated as gels.
It would have been obvious to use guar gum as the viscosity builder in the method
taught by Salamone. Salamone identifies guar gum as a viscosifying agent. See KSR Rationale E (MPEP 2143 Rationale E). While Salamone discloses other viscosity building agents, motivation to use guar gum specifically is provided by Agro Gums, which teaches 1) guar gum is widely preferred for its viscosity increasing properties 2) has a high hydration rate which mean it can swell fast in aqueous solutions and 3) is used in the production of therapeutic formulations to forms gels and viscous dispersions. One would have had a reasonable expectation of success since Salamone teaches it can be used in the disclosed method of treatment. One would have expected similar results since both references are directed to viscosifying agents.
It would have been obvious to use 2.6% to 3.5% guar gum in the composition taught by Salamone. One would have been motivated to do so since Salamone teaches viscosity building agents can be used at a concentration between 1-10% by weight. Salamone teaches water-soluble polymers are used in gels to increase solution viscosity and prolong residence time of the enzymatic composition on the necrotic tissue, on the surface of a wound, or subcutaneously in a wound. The skilled artisan would optimize within the range taught by Salamone to obtain a gel with the desired residence time on a wound. Because the claimed amount of viscosifying agent (guar gum) is rendered obvious, it would be expected to produce a composition with the claimed viscosity. See MPEP 2133.03 and MPEP 2144.05. Therefore claim 20 is rendered obvious.
Therefore Applicant’s invention is rendered obvious as claimed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE MOSS whose telephone number is (571) 270-7439. The examiner can normally be reached on Monday-Friday, 8am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is (571) 270-8439.
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/NATALIE M MOSS/ Examiner, Art Unit 1653
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