Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/06/25 has been entered.
Claim Status
Claims 60 and 61 are new.
Claims 2-36 and 43 are cancelled.
Claims 1, 37-42 and 44-62 are pending.
Claims 56, 58 and 59 are withdrawn.
Claims 1, 37-42, 44-55, 57 and 60-61 are under examination.
Withdrawn rejections
Applicant's amendments and arguments filed 11/06/25 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn. Claims 1, 37-55 and 57 were rejected under 35 U.S.C. 103(a) as being unpatentable over Hissink et al. (WO2004062704) and Zuidema et al. (US20120114592) and Park et al. (US20080146983) and Hardy et al. (US20100092525). This rejection is withdrawn in favor of the modified rejection below.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
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 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(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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, 37-55, 57, 60 and 61 are rejected under 35 U.S.C. 103(a) as being unpatentable over Hissink et al. (WO2004062704) and Zuidema et al. (US20120114592) and Park et al. (US20080146983) and Hardy et al. (US20100092525) and Zou et al. (Polym. Bull. 2009;62:713-725; of record) as evidenced by Piotrowska-Kirschling et al. (Polymers 2020, 12, 1205; 17 pages).
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Applicant claims a bioresorbable hemostatic foam comprising a phase-separated polyurethane polymer of claims 1 and 61 blended with a chitosan polymer.
Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical wound healing hemostatic research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from hemostatic medicine, hemostatic pharmaceuticals and devices, wound dressing techniques and wound healing procedures— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 1, 37, 39, 41, 52-54, 60 and 61, Hissink et al. is directed to biodegradable foam for packing antrums or other cavities of the human or animal body (Abstract) for controlling bleeding (a haemostatic sponge) (Page 1, lines 1-6; claims 31-32). Hissink et al. teach: “Closure with a bioresorbable foam of the present invention has the advantage of lower discomfort to the patient. Closure with an[sic] bioresorbable foam of the invention protects the maxillary sinus from being infected.” (Page 19, lines 26-29). Hissink et al. teach polyurethane and/or polyester units combined with polyethers, which are phase separated (Abstract; Claims 1-18) with amorphous hydrophilic soft segment and a crystalline hard segment (Page 4, lines 17-18; page 13, lines 26-30) with PEG as the soft segment (Page 14, lines 29-30), which would make polyurethane the hard segment (Page 12, lines 5-15; claim 13). Hissink et al. teach in claim 3 a formula (I):
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Hissink et al. teach an embodiment where p is 1 and q is 1 (Page 28, lines 17-25). What Applicant is claiming as R’’’ appears to be R’’ of Hissink et al. and Hissink et al. teach an overlapping number of carbons in the alkylene group.
Hissink et al. further teach in claims 10 and 11:
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Hissink et al. teach that the foam material according to the present invention is preferably prepared by a freeze-drying process. (Page 35, lines 3-4).
Regarding claims 1, 49-51, 60 and 61, Hissink et al. teach that the foam has a density of 0.01-0.2 g/cm3, preferably 0.03-0.07 g/cm3 (Claim 17) and a porosity of 85-99%, preferably from 92-98%, even more preferably from 95-98% (Page 21, lines 1-5). Since Hissink et al. teach the same density as claimed by Applicant, then it appears immaterial as to how that value was calculated by Hissink et al.
Regarding claims 1, 37-38, 40, 42, 52-54, 57 and 61, Hissink et al. teach that R can be derived from L, D or LD lactide and Ɛ-caprolactone and the polyesters comprises polyethylene glycol (Page 31, lines 10-29; Page 32, lines 1-5; claim 9; Example 5).
Regarding claims 1, 39, 41 and 52-54, 57, 60 and 61, Hissink et al. teach that R’ can be derived from 1,4-butanediisocyanate (BDI) which will provide the 1, 4-butanediyl and R’’ can be derived from 1,4-butanediol (BDO) which will also provide the 1,4-butandiyl for R’, R’’ and R’’’ (Page 27, lines 4-13; Page 28, lines 17-30 teaching a polyurethane with BDI-BDO-BDI-BDO-BDI). Given that Hissink et al. teach that R’ and R’’ can be C2-C8 alkylene, which includes C3 and C6, then 1,3-propanediyl and 1,6-hexanediyl are obvious when read in view of the BDI and BDO examples.
Regarding claims 1, 43 and 61, as noted above Hissink et al. is directed to bioresorbable/biodegradable porous absorbant materials. Hissink et al. also teach that cross-linked polyurethane-based hydrogels are biodurable and not biodegradable and are less suitable for use (Page 2, lines 5-17). Thus, crosslinked polyurethanes are not suitable for the biodegradable foams of Hissink et al. Hissink et al. further teach: “The polymeric material may also be composed of mixtures of above components either as different building blocks of the copolymer or cross-linked polymer or as a blend of two or more (co)polymers.” (Page 17, lines 16-19). Thus, embodiments such as a blend of phase-separated polymers, where the degree of crosslinking is about 0 are taught.
Further regarding claims 1, 57 and 61, Hissink et al. teach that the foams can be impregnated with various substances including hemostatic components (Page 37, lines 20-26). The Examiner notes for the record that Applicant’s own specification acknowledges these teachings of Hissink et al.: “The polymer present in the hemostatic foam of the invention is preferably a phase-separated polymer comprising an amorphous segment and a crystalline segment, wherein at least said amorphous segment comprises a hydrophilic segment. Such a polymer is described in WO-A-5 2004/062704. These polymers were found to show a particular good enhanced hemostatic effect in combination with hemostatic agents.”
Zuidema et al., where Zuidema is also an inventor of WO2004062704, cites Hissink et al. [0020, 0022, 0047] and guides the artisan to biodegradable phase-separated polyurethane foam haemostatic agents having the structure:
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([0036]; claim 5) where:
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The foam of Zuidema et al. has the same density and porosity as claimed:
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Zuidema et al. teach that the foam is bioresorbable and an embodiment where p = 1 and q = 1 (Claims 1-9) and that in a polymer blend, cross-linking it typically avoided [0014].
Regarding claims 1, 44-48, 55, 57 and 61, Park et al. is directed to polyurethane foam dressings comprising a wound healing accelerator such as chitosan (Abstract; [0033-0034]; claims 1, 9 and 10) in an amount of 0.5~15 weight % (Claim 7; [0026]), which overlaps the ranges of at least 5 wt% or at least 2 wt% and less than 35 wt% or less than 5 wt% of the weight of the foam. Park et al. teach simple mixing and stirring of the components (Claim 7) and teaches stirring at 4000 rpm for 5 seconds at room temperature [0056]. As evidenced by Piotrowska-Kirschling et al., “In the case of foams and water-borne polyurethanes, after dissolving chitosan in an aqueous acid solution, urea groups between chitosan and diisocyanate are expected.” (Page 13, Conclusions). Consequently, the ordinary artisan in this art understands that dissolving both chitosan and the diisocyanate compound is required for chemical bonding and the method of Park et al. does teach or suggest so doing. Rather Park et al. suggest just a quick mixing of the components.
Regarding claims 1, 44-46, 51, 55, 57 and 61, Hardy et al. teach that chitosan acetate is a known haemostatic agent [0046-0048]. Hardy et al. also teaches that the therapeutic agent can have a particle size of about 1-500 microns [0022] and that the therapeutic agent comprises haemostatic chitosan acetate salt (Claims 1 and 39-41).
Regarding claims 1, 47, 48, 55 and 61, Zuo et al. teach blend membranes of polyurethane and chitosan powder and report: “The result showed that SCP content had little influence on the cross-section structure of the blend membranes, and the cross-section presented a cellular structure. WAXD results revealed that the aggregated structure of SCP remained. With an increment of SCP content, the pore diameter and porosities of blend membranes increased firstly, and then decreased. While, the water absorption rate and water vapor transmission rate were improved remarkably with increasing SCP content. The mechanical testing results indicated that with an increment of SCP ratio, mechanical properties presented a descending trend (Abstract). Zuo et al. further state: “With 10% SCP, most powder was enwrapped by PU in the membrane, so the destruction effect was small. But, when the ratio of powder was above 30%, this destruction effect became more obvious.” (Page 724, 1st paragraph and Table 3 Mechanical properties of blend membranes with different SCP contents; Page 723, Mechanical properties: “The result indicated that there was an obvious decrease in elongation at break, tensile strength at break and elastic modulus of the blend membranes with the ratio of SCP increasing.”). An upward trend was reported for elastic modulus at 10% chitosan (Table 3). Zuo et al. conclude: “The mechanical testing results indicated that with the increase in the ratio of SCP to PU, mechanical properties presented a downtrend for rigid chitosan powder” (Page 724, Conclusion).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Hissink et al. is that Hissink et al. do not expressly teach a chitosan polymer blended with the phase separated polyurethane polymer in an amount of at least 2 wt% and less than 35 wt% or at least 5 wt% and less than 35 wt% or at least 2 wt% and less than 5 wt% of a total weight of the hemostatic foam in the form of particles having sizes smaller than 150 microns and is chitosan acetate and a degree of crosslinking of about 0. This deficiency in Hissink et al. is cured by the teachings of Zuidema et al., Hardy et al. and Park et al.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to make the phase-separated polyurethane haemostatic foam of Hissink et al. and/or Zuidema et al. and add a chitosan acetate polymer blended with the phase separated polyurethane polymer in an amount of at least 2 wt% and less than 35 wt% or at least 5 wt% and less than 35 wt% or at least 2 wt% and less than 5 wt% of a total weight of the hemostatic foam in the form of particles having sizes smaller than 150 microns, as suggested by Park et al. and Hardy et al., and a degree of crosslinking of about 0, as suggested by Hissink et al. and Zuidema et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because for the following sound articulated reasoning with rational underpinning based upon the evidence. First of all, the polyurethane foam of Hissink et al. is the same polymer claimed: “The polymer present in the hemostatic foam of the invention is preferably a phase-separated polymer comprising an amorphous segment and a crystalline segment, wherein at least said amorphous segment comprises a hydrophilic segment. Such a polymer is described in WO-A-5 2004/062704.” (Page 9, lines 1-6 instant specification). So, the claimed hemostatic phase-separated polyurethane foam is a sub-genus of the genus of polyurethane foams taught by at least Hissink et al. and by extension Zuidema et al. who also cites Hissink et al. This point was hashed out in prosecution of the parent applications. Secondly, Hissink et al. teach polymer blends (Page 24, lines 3-15; page 48, lines 15-17) and to avoid crosslinked polyurethane foams because those are biodurable and not biodegradable. Additionally, Zuidema et al. teach that crosslinking is avoided in a polymer blend. Thus, not only is the ordinary artisan motivated to avoid crosslinking the polyurethane foam because crosslinking imparts durability and not biodegradability but also the degree of crosslinking is about 0 for polymer blends. Thirdly, Hissink et al. teach and suggest adding haemostatic components (Page 37, lines 25-26). In looking to the art for haemostatic components, the artisan finds Park et al. teaching polyurethane foam dressings comprising a wound healing accelerator such as chitosan (Abstract; [0033-0034]; claims 1, 9 and 10) in an amount of 0.5~15 weight % (Claim 7; [0026]) as well as Hardy et al. teaching that chitosan acetate is a known haemostatic agent [0046-0048] that is employed in a particle size of about 1-500 microns [0022]. Additionally, Zou et al. suggest to the artisan to avoid going over 30 wt% chitosan because the “destructive effect became more obvious.” (Page 724, 1st paragraph of Zou et al.). The weight % and particle size taught in the art embraces or overlaps the claimed amount and particle size thus rendering the claimed ranges obvious. See MPEP 2144.05(I): In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Accordingly, the ordinary artisan would select chitosan acetate, in the amount and particle size ranges claimed, as a haemostatic component to add to the phase-separated polyurethane foams of Hissink et al. and/or Zuidema et al., with a reasonable expectation of success. The ordinary artisan is motivated to do so because not only does Hissink et al. suggest adding other haemostatic components but the art of Park et al. has already done so. The ordinary artisan would add the chitosan for its desirable wound healing accelerating properties as taught by Park et al. Chitosan also has the desirable properties of forming a gel which stems blood flow [0046] and has antibacterial properties to reduce the risk infection [0047] as taught by Hardy et al. Thus, the ordinary artisan is strongly motivated to blend chitosan acetate with the phase-separated polyurethane polymer of either Hissink et al. or Zuidema et al. to produce the claimed invention. Consequently, the ordinary artisan would have a reasonable expectation of success in formulating a bioresorbable haemostatic foam according to instant claim 1 wherein the phase-separated polyurethane polymer has a degree of crosslinking of about 0; the chitosan polymer is present in at least 2 wt% and less than 35 wt% or at least 5 wt% and less than 35 wt% or at least 2 wt% and less than 5 wt% in the hemostatic foam in the form of particles having sizes smaller than 150 microns; the hemostatic foam has a porosity in the range of 95-98% or 85-99%; and the hemostatic foam has a foam density in the range of 0.03-0.07 g/cm3 , p is 1, q is 1 and appropriate R’, R’’ and R’’’ is obvious over the combined references.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments:
Applicant’s arguments filed on 11/6/25 have been carefully considered but are not persuasive. The arguments are substantially the same as those presented previously.
On pages 9-10 of remarks, Applicant asserts that: “the person of ordinary skill in the art would have understood that it was the hydrogen bonding between hard segments that is responsible for the good mechanical properties of a substantially non-crosslinked phase-separated polyurethane, and that such hydrogen bonding would have been negatively impacted by the addition of a different hydrogen bonding substance like chitosan. Thus, the person of ordinary skill in the art would have expected the addition of chitosan to significantly diminish the mechanical properties of the polyurethane.” Respectfully, the Examiner has a different perspective. While it is correct that chitosan particles can influence the polyurethane chains ordering and interaction, the degree of that influence is dependent upon the amount of chitosan added and the size of the chitosan particles. See Piotrowska-Kirschling et al. teaching: “Presence of chitosan particles in polyurethane network influences chains’ ordering and interaction. Consequently, the properties of the resulting composite are changed in comparison to pure polyurethane. The extent and direction of these changes depend largely on the amount of added chitosan particles, their size, and the strength of their interaction with polyurethane chains.” (Page 3, last paragraph). See also Zou et al. teaching that polymer blends with 50 and 70 wt% chitosan content can weaken interaction of polyurethane chains (Page 723, 1st paragraph) where the addition of such high amounts of chitosan destroyed the regular and uniform structure of polyurethane to make the polyurethane membranes more and more brittle as the amount of chitosan increased in the membrane (Page 723, Mechanical properties). Zou et al. expressly state that the destructive effect with 10% chitosan was small (Page 724, 1st paragraph). With the combined references in hand the ordinary artisan would understand that addition of 10% chitosan powder to a polyurethane would have little destructive effect but that greater amounts of chitosan can be destructive.
On page 10 of remarks, Applicant summarized those arguments with reference to Dr. Jacob’s Declaration and earlier responses.
On pages 11-12 of remarks, Applicant asserts that addition of a hydrogen bonding molecule like chitosan would have been expected to interrupt the H-bonding of the hard segments of the polyurethane and diminish the mechanical properties. However, there is a caveat to that statement. In light of the teachings of Zou et al. above, the addition of large amounts of chitosan would have been expected to interrupt the H-bonding of the hard segments of the polyurethane and diminish the mechanical properties; not small amounts of chitosan. The Examiner does not dispute that H-bonding can occur between chitosan powder and polyurethane. That is a fact. The Examiner disputes Applicant’s characterization of the prior art in that any amount of chitosan would diminish the mechanical properties. That is simply not true.
On pages 12-13, Applicant asserts that the polyurethane polymers of Park are crosslinked and provides no mechanical data around any inclusion of any adjuvants. However, the Examiner is not relying on Park for teaching the claimed polyurethane polymer. It is impermissible to attack references singly when the Examiner relies upon the combined teachings of the references, nor may they attack a reference for not teaching a limitation of the claim when the Examiner has explicitly relied upon another reference as teaching that limitation. See In re Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000).
On page 13, Applicant asserts: “There is nothing here suggesting that "the reduction of mechanical properties would be minimal and would not affect the ability of the polyurethane foam to function for its intended purpose" as alleged by the Office.” Respectfully, the Examiner cannot agree because Zou et al. expressly teach that with 10% chitosan any destructive effect is small and Park teaches and suggests adding 0.5-15 wt% chitosan. The only reasonable conclusion is that any destructive effect from adding 0.5-15 wt% chitosan to the polyurethane would be small/minimal in view of the combined references.
On page 13 of remarks, Applicant points to KR’778 and the Jacobs Declaration. The Examiner has responded to the Jacobs Declaration previously, and that discussion is incorporated by reference, and does not agree with the conclusions provided by Dr. Jacobs.
On pages 13-14 of remarks, Applicant asserts that evidentiary reference Piotrowka-Kirschling can provide little expectation of how chitosan would affect the claimed chain-extended phase-separated polyurethanes because no molecular details for the tested polyurethanes were provided. However, Zou et al. is prior art and teaches just how the amount of chitosan can influence hydrogen bonding in polyurethanes thereby providing some degree of predictability. While Zou et al. may not teach the claimed polyurethanes, the claimed polyurethanes still can hydrogen bond like other polyurethanes. Thus, Zhou et al. is relevant art for what it teaches. See MPEP 2143.02(II): Obviousness does not require absolute predictability, however, at least some degree of predictability is required. The ordinary artisan would expect large amounts of chitosan to interfere with polyurethane H-bonding and be detrimental to mechanical properties; but the effect of small amounts of chitosan would be minimal.
On pages 14-15 of remarks, Applicant discusses the data presented by Dr. Jacobs as being unexpectedly good and notes increased resiliency characterized as “surprising – and impressive – result”. However, the Examiner notes that Zou et al. also report an increase in elastic modulus with 10% chitosan (Table 3).
On page 16 of remarks, Applicant states: “The addition of chitosan did not cause a reduction in tensile strength - this too was a "surprising - and impressive - result." And in fact, addition of chitosan caused a decrease in elongation at break.” However, the Examiner notes Table 3 of Zou et al. where there is no significant difference between the tensile strength of polyurethane (8.19 ± 0.76) and 10% chitosan (7.71 ± 0.35) and elongation at break decreased from 385 ± 5 to 340 ± 3. Applicant asserts that the presence of chitosan did not greatly effect water absorptiveness. However, Zou et al. teach: “As SCP content increasing 0–30 wt%, both porosities and water absorption percentage increased.” Further regarding the porosity, Zou et al. found: “it is found that the porosities and thickness of membranes firstly increase and subsequently decrease with SCP mass ratio increasing.” (Page 717, Porosity of SCP/PU blend membrane). Thus, porosity would be expected to remain the same or increase with the amount of chitosan taught in the art. It appears to the Examiner that all of the alleged impressive results are expected and predictable.
On pages 17- 18, Applicant discusses that the data is commensurate in scope with the claims. Applicant further asserts that: “one can compare the samples made from BDI-BDO-BDI chain-extended polymer in the absence of chitosan polymer to those made from BDI-BDO-BDI chain-extended polymer in the presence of chitosan polymer. The Office's primary reference is Hissink, which teaches BDI-BDO-BDI chain-extended polymer without chitosan polymer. Thus, this comparison is a comparison with the closest prior art - in a controlled experiment that demonstrates the effect of the presence of chitosan polymer at various loadings on various mechanical properties of the claimed polymer.” The Examiner has previously discussed this subject in the last response which is incorporated by reference.
On pages 18-19 of remarks, Applicant argues: “the polyurethane/chitosan material claimed provides better-than expected mechanical properties. The addition of chitosan actually improved compression resistance and elongation at break, each of which would have been expected to be diminished by the chitosan.” The Examiner disagrees for the reasons provided above discussing those properties.
On pages 19-20, Applicant argues commercial success. Respectfully, the Examiner does not find this persuasive because, as stated before, it is unclear if the HemoPore® product actually contains the same components as claimed. The advertising brochure filed 3/5/25 mentions chitosan lactate but does not appear to provide all components in the product. See MPEP 716.03(a): “An affidavit or declaration attributing commercial success to a product or process "constructed according to the disclosure and claims of [the] patent application" or other equivalent language does not establish a nexus between the claimed invention and the commercial success because there is no evidence that the product or process which has been sold corresponds to the claimed invention, or that whatever commercial success may have occurred is attributable to the product or process defined by the claims. Ex parte Standish, 10 USPQ2d 1454, 1458 (Bd. Pat. App. & Inter. 1988).” It seems that the presence of chitosan lactate is driving the success and not the invention as claimed. Furthermore, “Merely showing that there was commercial success of an article which embodied the invention is not sufficient. Ex parte Remark, 15 USPQ2d 1498, 1502-02 (Bd. Pat. App. & Inter. 1990)” (MPEP 716.03(b)(I)). For at least these reasons, arguments concerning commercial success are not persuasive at this time.
Summary:
The prior art teaches and suggests the claimed bioresorbable phase-separated polyurethane foam and to add hemostatic agents (Hissink and Zuidema).
The prior art teaches chitosan acetate as a hemostatic agent (Hardy).
The prior art teaches polyurethane foams with 0.5-15 wt% of wound healing accelerator chitosan (Park).
The prior art teaches when chitosan powder is added to polyurethane there is an expectation of minimal destructive effect to the mechanical properties of the polyurethane with low amounts (10%) of chitosan (Zou).
The test for obviousness is "what the combined teachings of the references would have suggested to those of ordinary skill in the art." In re Keller, 642 F.2d 4I3, 425 (CCPA I98I) (MPEP 2145(III)). In the present case, the combined references render obvious combining hemostatic chitosan acetate with the polyurethane of Hissink/Zuidema within the amounts claimed to produce a bioresorbable hemostatic foam with a reasonable expectation of success.
Applicant’s secondary considerations have been carefully considered but are insufficient to overcome the rejection. See MPEP 2145: Evidence pertaining to secondary considerations must be taken into account whenever present; however, it does not necessarily control the obviousness conclusion. See, e.g., Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1372, 82 USPQ2d 1321, 1339 (Fed. Cir. 2007) (“the record establish [ed] such a strong case of obviousness” that allegedly unexpectedly superior results were ultimately insufficient to overcome obviousness conclusion). The claimed hemostatic foam functions as a hemostatic foam with no apparent synergistic or enhanced function.
Conclusion
No claims are allowed.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613