Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
Claim 62 is new.
Claims 2-36, 43 and 57 are cancelled.
Claims 1, 37-42, 44-56 and 58-62 are pending.
Claims 56, 58 and 59 are withdrawn.
Claims 1, 37-42, 44-55 and 60-62 are under examination.
This Action is FINAL.
Withdrawn rejections
Applicants’ amendments and arguments filed 7/22/26 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 Any rejection and/or objection not specifically addressed below is herein withdrawn.
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, 37-42, 44-55 and 60-62 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, 61 and 62 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 and 60-62, 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 that embraces butanediyl of claim 62. Hissink et al. also teach using 1,4-butanediol (Page 28, lines 3-16).
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 and 60-62, 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 and 61-62, 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 and 60-62, 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 61-62, 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 and 61-62, 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 and 61-62, 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 and 61-62, 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 61-62, 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 Declaration and Arguments
The Declaration of Jaco Jacobs filed 7/22/26 has been carefully considered but is insufficient to overcome the 103 rejection.
The Declaration does not provide any new objective evidence of non-obviousness. Rather the Declarant first attacks the reference of Park as being directed to crosslinked polyurethanes. The Examiner is not relying upon the crosslinked polyurethanes taught in Park but rather the un-crosslinked polyurethanes of Hissink and Zuidema et al., which are the same un-crosslinked polyurethanes claimed. Arguments directed to Park are simply a distraction that pulls attention away from the main point being discussed by introducing an irrelevant issue.
In paragraph 9 of the Declaration, the Declarant asserts: “nowhere does Piotrowska-Kirschling suggest that dissolution is required; rather, it merely states that when diisocyanates and chitosan are dissolved together in aqueous solution they will react with one another. The person of ordinary skill in the art understands that polyurethane systems do not require dissolution in solvent for reaction of isocyanates with alcohols and amines”. However, the Declarant cites no objective evidence to substantiate their position. Rather, the objective evidence of record requires both chitosan and diisocyanates to be dissolved together in order for a reaction to occur.
The Declarant then discusses the references of Zou and points out that the polyurethane polymers discussed in Zou are different from those claimed. In paragraph 17 of the Declaration, the Declarant states: “The difference in the overall stability of the polyurethanes at issue here - the material of Hissink being much less stable than the Pellethane® polyurethanes - means that data from Zou regarding stability of the Pellethane® 2673-80AE in the presence of chitosan cannot be applied directly to the much less stable materials of Hissink. Even if the Pellethane® material were stable to addition of large amounts of chitosan, given the lower stability of Hissink's materials due to their very different structure, there could be no expectation that the same would be true for the claimed combination.” The Declarant states: “the data in Zou cannot be applied to the materials of His sink in combination with chitosan.” The Examiner disagrees because the Declarant’s position is one of speculation. The expectation is a reasonable one. Even the Declarant admits in paragraph 26 that: “I understand that the Office appears to make the point that a de minimis addition of chitosan would not be expected to have a significant effect on a polyurethane. This, of course, is true.” And in paragraph 29: “a de minimis amount of chitosan would not be expected to affect mechanical properties”. That has been the Examiner’s position and nothing provided by the Declarant has changed the Examiner’s position. Thus, arguments directed to porosity and other mechanical features are just arguments with insufficient weight to change the Examiner’s position. The Declarant asserts: “I disagree with the Office's apparent view that the references suggest that adding 0.5-15 wt% chitosan to any polyurethane would not have a significant effect on mechanical properties.” But the Declarant has contradicted themselves because the Declarant stated that “a de minimis amount of chitosan would not be expected to affect mechanical properties”.
The Examiner has addressed the data in the first Declaration previously and the Examiner’s response is incorporated by reference. The Declarant states that the HemoPore® product meets the limitations of each and every claim of this patent. However, a complete list of components in the HemoPore® product was not provided. Respectfully, none of the Declarant’s arguments are persuasive.
Applicants’ 29 pages of arguments filed on 7/22/26 have been carefully considered but are not persuasive.
On page 11 of remarks, Applicant states: “The use of a phase-separated polyurethane polymer like those claimed here (and those described in Hissink) can provide improved mechanical properties.” So, the improved mechanical properties are an inherent feature of the polymers disclosed by Hissink.
On page 12 of remarks, Applicant states: “But addition of a hydrogen-bonding molecule like chitosan would have been expected to interrupt the hydrogen bonding of the hard segments of the polyurethane, and thus diminish the polyurethane's mechanical properties”. However, the Declarant has expressly stated: “that “a de minimis amount of chitosan would not be expected to affect mechanical properties”. That is a contradiction.
On page 14 of remarks, Applicant states: “The Office now appears to assert that the polyurethane system of Park is somehow not crosslinked”. The Examiner’s position is that the polyurethane system of Park is not crosslinked with chitosan. References to the fist and second Jacobs Declaration are noted and have been addressed here and in the record. None of the Declarations have provided persuasive arguments or objective evidence of nonobviousness. The Examiner is relying upon the uncrosslinked polymers of Hissink; not the crosslinked polymers of Park. 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).
Applicant discusses KR'778. KR'778 is not an applied reference. Arguments directed to KR'778 are moot.
Applicant refers to the second Jacobs Declaration with regard to the prior art of Zou. The Examiner’s response to the Declaration’s interpretation of Zou can be found supra. Those arguments by the Declarant are not persuasive for the reasons provided above. The expectation of success only has to be reasonable with some degree of predictability, which the prior art references of Zou and Piotrowska-Kirschling provide. See MPEP 2143.02(II): Obviousness does not require absolute predictability, however, at least some degree of predictability is required. Evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness. In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). At this time, Applicant has provided no evidence of no reasonable expectation of success.
Applicant asserts: “the person of ordinary skill in the art would have expected the addition of chitosan to interfere with the hydrogen bonding of a substantially non-crosslinked phase-separated polyurethane, and thereby to cause a diminution in mechanical properties of the polyurethane.” That assertion is expressly contradicted by the Declarant stating: “a de minimis amount of chitosan would not be expected to affect mechanical properties”. Applicants arguments are not persuasive.
Applicant points to the Jacob Declaration for unexpectedly good performance. However, in this record it has been noted that the polymers of Hissink are the same as claimed and have the same mechanical properties and a de minimis amount of chitosan is not expected to change those mechanical properties. There has been no showing of significant improvement. A demonstration of mere improvement, without a showing that the improvement is significant or unexpected, is insufficient evidence of unexpected results. See In re Soni, 54 F.3d 746, 751 (Fed. Cir. 1995). Accordingly, Applicant’s assertion that: “this comparison with the closest prior art demonstrates that the good mechanical properties of the substantially non-crosslinked block chain-extended phase-separated polymer of Hissink is unexpectedly maintained - and in some cases even improved - with addition of chitosan polymer” is expected and not significant. Similarly, Applicant’s assertion that: “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. And many other mechanical properties remained about the same in the presence of chitosan, opposite the expectation of diminution”; is actually expected and not significant at all. Applicant states: “Mechanical properties are important in a dressing, especially a nasal dressing, because compression provides pressure to stop bleeding, and materials should be strong enough not to fracture during removal. This is sufficient to show patentability, even if the blood clotting time data presented in the specification do not suggest that the chitosan itself works better in the claimed system than in other contexts.” No, it is not sufficient to show patentability. Essentially Applicant has admitted that the data does not suggest any superior activity from the addition of chitosan to the claimed system. Consequently, it does not rise to the level of patentability without more. Applicants’ arguments are not persuasive.
Arguments directed to commercial success have been addressed previously. Applicant asserts: “it is absolutely clear that the HemoPore® product actually contains the same components as claimed. Dr. Jacobs has stated unequivocally that "[t]his product falls within the scope of the claims." No, it is not clear because the Declaration has not provided specifically named components in the product.
Applicant argues that: “the Office appears to make the point that a de minimis addition of chitosan would not be expected to have a significant effect on a polyurethane. This, of course, is true. But, as shown by the data in the papers cited, a significant amount of chitosan would be expected to cause a significant change in properties. Second Jacobs Declaration, paragraph 0026. And the person of ordinary skill in the art would appreciate, the threshold amounts of chitosan that would cause measurable or significant effects on mechanical properties will differ for each polyurethane.” But Applicant just agreed that a de minimis addition of chitosan would not be expected to have a significant effect on a polyurethane. Applicants’ statements that a de minimis amount of chitosan would not be expected to have a significant effect on a polyurethane and the statement that the person of ordinary skill in the art would appreciate, the threshold amounts of chitosan that would cause measurable or significant effects on mechanical properties will differ for each polyurethane are contradictory. As such, Applicant’s arguments are not persuasive.
The Examiner has carefully considered the 29 pages of arguments that are largely repetitive of previous arguments in this record, and the Examiner’s responses can be found in the record, with no additional factual evidence of non-obviousness. The Examiner is unpersuaded.
Conclusion
No claims are allowed.
Applicants’ 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 ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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/ERNST V ARNOLD/ Primary Examiner, Art Unit 1613
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