DETAILED ACTION
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 .
This office action is in response to the reply filed 11/13/2025.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-9 and 14-15, in the reply filed on 3/11/2024 is acknowledged.
Response to Arguments
All of Applicant’s arguments filed 11/13/2025 have been fully considered.
The 112(b) rejections as presented in the office action mailed 8/13/2025 are withdrawn as the issues have been resolved.
Applicant argues that the claim as amended are limited to ethanol and hemoglobin and in view of the data presented in the specification the successful immobilization of hemoglobin in ethanol was unexpected.
This is not persuasive. As previously discussed as the data presented in the specification just shows a property of claimed invention, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Applicant remarks that the claimed method is responsible for this, but there is no comparative data showing that the order of the method steps is critical to obtaining the stated effect. In order to show unexpected results, Applicant must compare the instant invention to the closest prior art, no comparisons have been provided.
Regarding the denaturing of the hemoglobin, the specification seems to equate this to the use of high temperatures and the use of low temperatures ensures the protein is not wholly denatures when contacted with the alcohol, however, this does not appear to be unknown and unexpected. As discussed in the new rejection below, JP’494 teaches that ethanol is known to denature proteins and performing the process step at low temperature (about -5°C) increases protein stability, thus it’s unclear what is unexpectedly superior about the results obtained by Applicant.
New 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.
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.
Claim(s) 1, 4-5 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watt (GB 2314842), Wegmann (US 2009/0280162) and Kettlewell (US 2014/0257221), Konaka (US 2015/0143672), WO 2014/168307 and JP H1129494, as evidenced by Schulte (US 2011/0282354) and Fisher Scientific. Fisher Scientific is newly cited.
Watt discloses protein/oxidized regenerated cellulose complexes (ORC). These are made by dispersing or dissolving protein in aqueous solvent, adding ORC and then removing the solvent. The complexes are used for wound dressings and the like (Abs). A suitable protein is collagen (Watt – claim 8).
Regarding claims 1 and 15: Watt teaches that other biocompatible polysaccharides such as carboxymethylcellulose (CMC) can be added, along with therapeutic wound healing agents (pg. 2-3). CMC is a gelling substrate capable of absorbing aqueous fluids, as evidenced by the originally filed specification [52] and as evidenced by Schulte, ORC is a gelling material [0036]. Thus, it would have been prima facie obvious to include CMC in the complex as this is specifically contemplated by Watts.
Watt teaches the complex to be made by providing an aqueous dispersion of a protein and immersing or dispersing ORC in the aqueous dispersion; followed by removing water from the aqueous dispersion to leave behind a complexed material in the form of a freeze-dried or solvent-dried sponge. Watt teaches that the water is preferably removed by freeze-drying (lyophilizing). Watt teaches that additional components (i.e. CMC and therapeutic agents) are preferably included in the aqueous dispersion prior to removal of the water (pg. 3 and 6).
However, Watt does not teach the use of ethanol when making the complex.
Wegmann discloses wound dressings comprising a biocompatible support material and at least one polysaccharide as a hemostatic agent (Abs). Wegmann teaches making the wound dressing by dispersing the support material in an aqueous liquid in particular a mixture of water and an alcohol. Wegmann teaches that preferably a mixture of water and isopropanol is used, such as 70wt% water to about 30wt% isopropanol. Wegmann teaches that the use of isopropanol (reading on instant claims 2-3) as an ingredient of a dispersion medium mixture is preferred for producing a homogenous dispersion of support material (for example, collagen) [0072].
Konaka teaches both ethanol and isopropanol to be good alcohols, in which the hydrocarbon has a hydrophobic nature and the hydroxyl group and the ether group have a hydrophilic nature, and these are preferred in terms of homogenous dispersion due to good compatibility with water [0036].
WO’307 teaches a highly liquid absorbent and hardly water-soluble carboxymethyl cellulose (CMC) foam, which absorbs body fluid or water (Abs). A suitable dispersion medium is ethanol or isopropanol (WP’307 - claim 9).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Watt with those of Wegmann. One of skill in the art would have been motivated to add isopropanol to the aqueous dispersion of Watt and maintain the water and isopropanol in the ratios taught by Wegmann as these ensure a homogenous dispersion of support material. One of skill in the art would have a reasonable expectation of success as both Watt and Wegmann teach methods of making wound dressing by dispersing proteins into aqueous dispersions. One of skill in the art would have been further motivated to substitute isopropanol with ethanol as these are taught by WO’307 and Konaka to be equivalent dispersion medium that are effective at obtaining homogeneous dispersions. One of skill in the art would have a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention and WO’307 teaches that ethanol is known to be used with celluloses.
Regarding claims 5 and 14: As discussed above, 70wt% of water can be calculated to be 70ml, while 30wt% ethanol is 37.58mL (calculated using the density of ethanol: .7983 g/ml as evidenced by Fisher Scientific), this provides a ratio of non-aqueous solvent to water of .54 which reads on the instant claims.
The above references do not make obvious the separate steps of 1) adding protein to water, then 2) adding isopropanol; 3) contacting the resultant mixture with a substrate and then 4) freezing-drying, the prior art makes obvious adding all the components (protein, CMC and ORC (i.e. reading on absorbent substrate material)) to a dispersion having both water and isopropanol in a single step and then freeze drying this mixture and it is well-established that the selection of any order of performing process steps and the selection of any order of mixing ingredients is prima facie obvious in the absence of new or unexpected results.
MPEP 2144.049 IV (C) Changes in Sequence of Adding Ingredients
Ex parte Rubin , 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facie obvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.).
However, the above references do not teach the absorbent fibrous substrate to be cellulose ethyl sulfonate as recited by instant claim 1.
Watt teaches the substrate comprising ORC and CMC may be in the form of non-woven fabrics (pg. 4, lines 15-20).
Kettlewell discloses absorbent materials for use in wound dressing (Abs). Kettlewell teaches that super absorbent gel-forming fibers are formed from polysaccharides including modified celluloses such as CMC and cellulose ethyl sulfonate (CES) [0021]. These can be present in a non-woven form [0033].
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Watt and Wegmann with those of Kettlewell. One of skill in the art would have been motivated to substitute the CMC of Watt with fibrous non-woven CES as these are taught by Kettlewell to be equivalent modified cellulose for forming absorbent fibers for preparing wound dressings. One of skill in the art would have a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention and Watt teaches that the substrate can be non-woven.
As recognized by MPEP §2144.06, it is prima facie obvious to substitute art-recognized equivalents, and an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).
However, the above references do not teach the entire method to be performed while maintaining the temperature below 15°C for each step as required by instant claim 4.
JP’494 demonstrates that ethanol is known to denature proteins and using low temperatures (typically -5°C) are required during processing to increase protein stability (pg. 8).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of the above references with those of JP’494. One of skill in the art would recognize that the ethanol solvent could denature the protein in Watt is too high of temperatures are used, thus it would have been prima facie obvious to use lower temperature, such as those below -5°C, for the method steps involving ethanol, as these temperature are known to increase protein stability. One of skill in the art would have a reasonable expectation of success as Wegmann demonstrate that temperatures of -10° to 30°C are suitable temperature for use in processes of making wound dressings.
Claim(s) 1, 4-5, 9 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watt (GB 2314842), Wegmann (US 2009/0280162) and Kettlewell (US 2014/0257221), Konaka (US 2015/0143672), WO 2014/168307 and JP H1129494, as evidenced by Schulte (US 2011/0282354) and Fisher Scientific, as applied to claims 1-3, 5 and 14-15 above, and further in view of Zal (US 2016/0175478).
As discussed above, the prior art makes obvious the limitations of claims 1, 4-5 and 14-15, however, they do not teach the protein to be an annelid derived hemoglobin as recited by instant claim 9.
Zal teaches the use of hemoglobin for the preparation of wound dressing and to the resultant dressings (Abs). Zal teaches that hemoglobin present in the blood steam transports oxygen from the lungs to the extremities of the limbs and when there is an open injury to the skin, the supply of oxygen by diffusion at the surface of the cells is then eliminated [0002-0003]. Zal teaches that hemoglobin can be used to promote wound healing [0014] and the dressing comprises hemoglobin immobilized and stable in a matrix based on CMC [0034 and 0077].
Regarding claim 9: Zal teaches a preferred hemoglobin to be an extracellular hemoglobin from an invertebrate animal chosen from the phylum Annelida [0072].
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of the above references with those of Zal. One of skill in the art would have been motivated to include hemoglobin as taught by Zal as a wound healing agent in the aqueous dispersion used to formulate the complex as Zal teaches it to be effective at promoting wound healing. One of skill in the art would have a reasonable expectation of success as both Zal and Watt teach methods of treating wound comprising CMC.
Conclusion
No claims are allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer A Berrios whose telephone number is (571)270-7679. The examiner can normally be reached Monday-Thursday from 9am-4pm and Friday 9am-3:30pm.
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/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613