DETAILED ACTION
The receipt is acknowledged of applicants’ amendment filed 06/25/2025.
Claims 13-25 are pending.
Claims 19-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 09/14/2020.
Claims 13-18 and 24-25 are subject of this office 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 .
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 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 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 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.
Claims 13-18 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. (WO 2010/025219) in view of Hissink et al. (WO 2004/062704), or alternatively, Hissink in view of Patel, and each combination further optionally combined with CA 2682291 (hereinafter CA ‘291), and the above combination further in view of Pauletti et al. (WO 2004/041118), all references are of record.
Applicant Claims
Claim 13 is directed to multilayered drug eluting biodegradable foam comprising at least two foam layers, wherein the at least two foam layers are directly stacked on top of each other, wherein the at least two foam layers have a porosity of 85-99%, wherein each layer independently comprises voids and a wall that comprises a polymer and wherein at least one of said layers is a drug-comprising layer, which comprises at least one drug that is mixed with the polymer in said drug-comprising layer, wherein the at least one drug is located in the wall of the foam of the drug-comprising layer and not in the voids such that the drug elutes upon degradation of the polymer, wherein each of the at least two foam layers individually comprises a polymer that is a phase-separated polymer comprising at least one amorphous segment and at least one crystalline segment, wherein said amorphous segment optionally comprises a hydrophilic segment.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Patel teaches wound dressing comprising at least one foam layer comprising therapeutic agent wherein the therapeutic agent is eluted from the foam (abstract; ¶ 0010; claim 14). The foam layers have benefit and advantage of absorbing the wound exudate while delivering therapeutic agent to the wound (¶ 0009). The foam comprises plurality of dissolvable members disposed and distributed within the foam, i.e. within the wall itself, and therapeutic agent is associated with the dissolvable members or present as dissolvable salt, and upon dissolution of the dissolvable members or salt, the therapeutic agent is eluted and released and voids are created in the foam and are left behind (abstract; ¶¶ 0046, 0048-0050). Suitable foam material includes polyurethane (¶ 0029; claims 1, 7). The reference teaches multiple foam layers comprising different densities, different swelling properties and different porosities that are stacked with each other without adhesive by curing or by adhesive. Further, Patel teaches casting or extruding the layers together, and casting and extrusion will provide two layers stacked together, and adhesive is another alternative to casting or extrusion, and not required, therefore, the layers are directly stacked on top of each other. The layers are stacked on each other and are bond by curing without adhesive. (¶¶ 0036, 0040, 0042, 0045, 0051). The foams provide controlled release of therapeutic agents including antimicrobial agents, anti-inflammatory agents, hemostatic agents, would healing agents, etc. (¶ 0054).
Hissink teaches biodegradable polymer foam for tissue regeneration and drug delivery purposes that further can be applied to the wound as wound dressing, absorbent foam, or applied at body antrum, e.g. nasal cavity, used as hemostatic sponge, e.g. laparotomy sponge, used as post-surgery dressing to prevent tissue adhesion, and can be dental surgery and after tooth extraction. The foam has advantage that it does not have to be mechanically removed (abstract; page 15, lines 22-25; page 16, lines 1-10; page 37, line 30; page 38, lines 1-12; page 48, lines 28-30; claim 32). The biodegradable foam has enough strength to be readily handled in surgical procedures, high elasticity, absorbs body fluid, comfortable, fits into any topography or space, resilient, and soft to avoid injury to sensitive tissues (page 3, lines 15-28). The biodegradable polymer foam comprises phase separated polymer consisting of an amorphous segment and crystalline segment, wherein the amorphous segment comprises a hydrophilic segment. The hydrophilic amorphous segment comprises polyethylene glycol (page 4, lines 321; page 6, lines 20-23). The biodegradable polymer foam having the formula:
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58
447
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wherein R is selected from one or more aliphatic polyesters, polyetheresters, polyethers, polyanhydrides and/or polycarbonates, and at least one R 15 comprises a hydrophilic segment, R1 and R" are independently C2-C8 alkylene, optionally substituted with C1-C10 alkyl or C1-C10 alkyl groups substituted with protected S, N, P or O moieties and/or comprising S, N, P or O (e.g. ether, ester, carbonate and/or anhydride groups) in the alkylene chain, Z1-Z4 are independently amide, urea or urethane, Q1 and Q2 are independently urea, 20 urethane, amide, carbonate, ester or anhydride, n is an integer from 5-500, p and q are independent 0 or 1, provided that when q is 0, R is a mixture of at least one crystalline polyester, polyetherester or polyanhydride segment and at least one amorphous aliphatic polyester, polyether, polyanhydride and/or polycarbonate segment. The O containing moieties in the alkylene chain, if 25 present, are preferably hydrophilic groups, in particular ether groups (pages 5-6; and claims 1-3). The reference discloses impregnation of the foam with various active substances that can be released in controllable manner upon wetting, such as hemostatic substances (page 37, lines 20-26). The reference teaches porosity of the biodegradable foam polymer preparation from 58-99%, and preferably from 92-95%, more preferably 95-98% (page 21, lines 1-5), and exemplifies 96.4% (page 42, example 9). Further the absorbent foam absorbs blood and provides hemostasis (page 19, lines 29-30). The reference teaches method of making the phase separated foam including the steps of dissolving the polymer in a solvent, completely removing solvent by freeze drying (page 35, lines 3-14, 20-23; and page 37, lines 20-30).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Patel teaches wound dressing comprising multiple polyurethane foam layers to deliver therapeutic agents to the wound including hemostatic agent and to absorb wound fluid, the reference however does not teach the claimed foam comprising phase-separated polymer comprising at least one amorphous segment and at least one crystalline segment as claimed by claim 13. The missing element from Patel is taught by Hissink.
While Hissink teaches the phase separated foam useful for wound dressing and for drug delivery to the wound including hemostatic agent, and useful to absorb wound fluid, e.g. blood, the reference does not explicitly teach multilayered foam as instantly claimed by claim 13. The missing element from Hissink is taught by Patel.
Patel and Hissink do not teach the foam layers are directly stacked on top of each other as claimed by claim 13. This missing element is taught by CA ‘291.
While Patel and Hissink suggest the present of the active agent in the wall of the foam, the references do not explicitly teach the voids of the foam do not contain active agents as instantly claimed by claim 13.
CA ‘291 teaches improved medical devices having improved method of treating patients and improved method for delivering therapeutic agents (page 5 first two paragraphs). The devices can be implants, hemostatic devices, medicated devices etc. (page 9, first paragraph). The device can be foam (page 11, last paragraph). The device is multilayered of same material but having different biocompatibility and different biodegradation, and different additives that are coated on each other, i.e. stacked on top of each other, and are dried for shape fixation (page 14, first full paragraph).
Pauletti teaches polymer foam for controlled and sustained delivery of therapeutic agents to and through body cavities as the foam breakdown, e.g. nasal cavity. The foam is absorbable or biodegradable and incorporates therapeutic agent that is released from the foam upon placement of the foam on the epithelial surface of the nose for example. The active agent includes anti-inflammatory agents (abstract; page 6, lines 1-7; page 8, lines 17-26; page 10, lines 27-32; page 15, lines 21-27; page 20, lines 33-35; page 35, lines 6-11). The process of making the polymer foam includes the steps of dissolving a mixture of the polymers and therapeutic agent(s) in a solvent and additive. The mixture is freeze dried to completely evaporate the solvent and form the pores of the foam (page 15, line 29 till page 16, line 24; page 23, line 12 till page 24 line 3). Additives can be added to the lyophilized foam (page 19, lines 28-35).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide wound dressing comprising multiple foam layers comprising polyurethane foam and therapeutic agent that is applied to the wound to elute therapeutic agent and absorb wound fluid as taught by Patel, and replace the polyurethane foam with the biodegradable polymer foam taught by Hissink that comprises at least one amorphous segment and at least one crystalline segment to form the multiple layers of foam in the dressing of Patel. One would have been motivated to do so because Hissink teaches such phase separated polymer foam can be applied to the wound with advantage that it does not have to be mechanically removed and has enough strength to be readily handled in surgical procedures, comfortable, fits into any topography or space, resilient, absorb body fluid, deliver active agent in a controlled manner, and soft to avoid injury to sensitive tissues. One would reasonably expect formulating wound dressing comprising multiple foam biodegradable layers comprising phase separated polymer that is soft, porous, resilient and safe to the surrounding tissues while delivering therapeutic agents to the wound and absorbing body fluid.
Alternatively, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide biodegradable phase separated polymer foam included in a wound dressing to deliver therapeutic agent and to absorb wound fluid as taught by Hissink, and provide the foam in the dressing in multiple layers as taught by Patel. One would have been motivated to do so because Patel teaches multilayered foam can provide different properties by each layer such as porosity, density, swelling property and elute therapeutic agents in controlled manner while absorbing wound fluid. One would reasonably expect formulating wound dressing comprising multilayered biodegradable phase separated polymer foam to deliver therapeutic agent to wound in a controlled manner while absorbing body fluid.
Further, optionally, one having ordinary skill in the art would have provided multilayered device having stacked layers that can be foam layered as taught by CA ‘291 because CA ‘291 teaches that such medical devices are improved medical devices having improved method of treating patients and improved method for delivering therapeutic agents and fixed shape.
Furthermore, one having ordinary skill in the art would have used the process of producing the foam taught by Pauletti comprising mixture of polymer and active agent that undergoes freeze drying to create the voids of the foam and eventually maintaining the active agent in the wall of the foam. One would have been motivated to do so because Pauletti teaches such a method provides foam for controlled and sustained delivery of active agents to and through body cavities as the foam breakdown upon placement of the foam on the epithelial surface.
Regarding claim 13, the claimed drug eluting phase separating polymer foam is taught by combination of Patel and Hissink that teaches release of therapeutic agent from the foam; i.e. drug eluting foam.
Regarding claim 13 that the amorphous segment optionally comprises hydrophilic segment, Hissink teaches this limitation.
Regarding the multilayered device as claimed by claim 13, Patel teaches multilayered foam in a wound dressing. Further, Patel teaches casting or extruding the layers together, and casting and extrusion will provide two layers stacked together, and adhesive is another alternative to casting or extrusion, and not required, therefore, the layers are directly stacked on top of each other. The layers are stacked on each other and are bond by curing without adhesive. Combination of Hissink and Patel teaches extruding or casting two layers together of phase separated polymer that are directly stacked and expected to form a strong bond.
Regarding the limitation of claim 13 that “wherein the at least two foam layers each individually has porosity of 85-99%”, Patel teaches two separate foam layers laminated to each other having porosity and Hissink teaches porosity of the foam from 85-99%, and one having ordinary skill in the art would have made the two porous layers of Patel each have porosity within the porosity taught by Hissink to achieve soft foam to absorb body fluid, deliver active agent in a controlled manner, and to avoid injury to sensitive tissues.
Regarding the limitation of claim 13 that the drug is substantially located in the wall of the foam and not the voids and eluted upon degradation of the polymer, Patel clearly teaches plurality of dissolvable members disposed and distributed within the foam, i.e. within the wall itself, and therapeutic agent is associated with the dissolvable members or present as dissolvable salts, and upon dissolution of the dissolvable members or salts, the therapeutic agent is eluted from the foam and released and voids are created in the foam and are left behind. This teaching implies the presence of the drug distributed in the wall of the foam, and released upon wetting the foam on use due to formation of pores. This is exactly what applicants had done, release of drug upon degradation of the foam. Further, Pauletti teaches the method applicants used to produce the foam comprising incorporating the active agent with the polymer then creating the voids by freeze drying, and the active agent is released upon degradation of the polymer.
Regarding stacking of the foam layers as claimed by claim 13, this is taught by Patel and CA ‘291.
Regarding the properties claimed by claim 14, Patel teaches multiple foam layers having different functions, e.g. porosities, densities, and swelling properties.
Regarding the biodegradable polymers claimed by claim 15, both Patel and Hissink teach polyurethane.
Regarding the formula of the phase separated polymer claimed by claim 16, the claimed formula is taught by Hissink.
Regarding the process of making the foam claimed by claim 17, the claimed steps are taught by Hissink including the steps of dissolving the polymer in solvent, mixing with active agent and freeze drying. Note that the process of making the foam does not impart patentability to product claims.
Regarding the active agents claimed by claim 18, Patel and Pauletti teach anti-inflammatory drugs and antimicrobial drugs, and both Patel and Hissink teach hemostatic agent.
Regarding the intended use of the claimed foam as claimed by claim 24, Patel and Hissink teaches polymer foam for controlled delivery of therapeutic agents and absorb body fluid, i.e. drainage, and Hissink teaches biodegradable polymer foam for tissue regeneration and drug delivery purposes that can be applied at body antrum, e.g. nasal cavity.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Patel in view of Hissink, or alternatively, Hissink in view of Patel, and further optionally combined with CA ‘291, and further combined with Pauletti as applied to claims 13-18 and 24 above, and further in view of either the article by Hong et al. (Systemic effect and safety of triamcinolone-impregnated nasal packing after endoscopic sinus surgery: A randomized, double-blinded, placebo-controlled study) or the article by Lavigne et al. (Steroid eluting sinus implant for in-office treatment of recurrent nasal polyposis: a prospective, multicenter study), all references are of record.
Applicant Claims
Claim 25 recites the drug comprises steroidal anti-inflammatory agent and a hemostatic agent.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
The combined teachings of Patel and Hissink, and optionally CA ‘291 and further combined with Pauletti are previously discussed in this office action.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Both Patel and Hissink teach hemostatic agents in their products, and Patel and Pauletti teach anti-inflammatory agent, however the reference does not explicitly teach steroidal anti-inflammatory agent as claimed by claim 25.
Hong teaches absorbable nasal dressing infused with triamcinolone (steroidal anti-inflammatory corticosteroid) after endoscopic nasal surgery to improve wound healing and to reduce recurrence of polyps. The reference teaches topical administration of corticosteroids is superior to systemic administration because this localizes their effect and minimizes their systemic side effects (see the entire document, and in particular the abstract and discussion).
Lavigne teaches steroid eluting implant can safely, feasibly and efficiently placed in patient with recurrent rhinosinusitis for treating obstructive polyposis (see provided abstract).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide biodegradable phase separating polymer foam comprising active agent including anti-inflammatory agent and hemostatic agent for use in the nasal cavity to release the active agents in controlled release rate as taught by the combination of Patel, Hissink, and optionally CA ‘291, and further combined with Pauletti, and replace the anti- inflammatory agent by steroidal anti-inflammatory agent taught by any of Hong or Lavigne. One would have used steroidal anti-inflammatory agent because Hong teaches steroidal anti-inflammatory agents improve wound healing and reduce recurrence of polyps after endoscopic nasal surgery while minimizing systemic side effects of steroidal anti-inflammatory agents, and because Lavigne teaches that steroid eluting implant can safely, feasibly and efficiently placed in patient with recurrent rhinosinusitis for treating obstructive polyposis. One would reasonably expect formulating biodegradable foam comprising phase separating polymer comprising steroidal anti-inflammatory agent and hemostatic agent to be delivered in a controlled rate when used in the nasal cavity after surgery wherein healing and hemostasis of the nasal cavity after surgery is improved.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Response to Arguments
Applicant's arguments filed 06/25/2025 have been fully considered but they are not persuasive.
Claim Rejections - 35 U.S.C. 103
Applicants argue that the person of ordinary skill in the art will understand that the dissolvable members or dissolvable salts of Patel are incompatible with the foam production process of Pauletti because Patel teaches that upon dissolution of the dissolvable members, antimicrobial agent is eluted and the pores or voids are created in the foam matrix (cf., for example, the abstract, par. [0012] and claim 18). Therefore, it follows that, according to Patel, the dissolvable members are to be included in the device in a form such that they can form pores or voids upon dissolution. Patel discloses that the dissolvable members can, for instance, be based on dissolvable beads (par. [0046]), supercritical carbon dioxide (par. [0047]), salt crystals (par. [0048]), sodium/calcium alginate particles (par. [0049]), and non-dissolvable nanofibers or spheres along with dissolvable particles (par. [0050]). The person of ordinary skill in the art will understand that if these members or salts are already dissolved in the foam production process as taught by Pauletti, they will disintegrate by dissolution and will not be reformed after the freeze-drying step. That is, the dissolvable beads, salt crystals, and particles will not reform after dissolution and freeze-drying. Instead, after freeze-drying, they will remain disintegrated and will have lost their intended purpose to be able to elute the antimicrobial agent and to form pores or voids upon dissolution. When a “proposed modification would render the prior art invention being modified unsatisfactory for its intended purpose, then there is no suggestion or motivation to make the proposed modification.” See MPEP 2143.01(V) citing In re Gordon, 733 F.2d 900, 221 USPQ 1125 (Fed. Cir. 1984).
In response to this argument, it is argued that Patel teaches the active agent is present in the wall or matrix of the foam till it is released. Once released active agents from the foam, the voids are created and are left behind. Presence of the active agents in the voids is only transient in their way to be delivered outside the foam leaving behind the voids. The claims language does not exclude the presence of the active agent in the voids during the release from the foam, and it is inevitable to have the active agents released from the foam without moving through the pores. The location of the active agent within the foam is determined by the process of its production, as applicants described in page 3, lines 6-14. The process of making the foam is not claimed, and does not impart patentability to the claimed product. Patel clearly teaches plurality of dissolvable members disposed and distributed within the foam, i.e. within the wall itself, and therapeutic agent is associated with the dissolvable members or present as dissolvable salts, and upon dissolution of the dissolvable members or salts, the therapeutic agent is eluted from the foam and released, creating the voids, and the voids are left behind after release of the actives. This teaching implies the presence of the drug distributed in the wall of the foam, and released upon wetting the foam on use due to formation of pores. This is exactly what applicants had done, release of drug upon degradation of the foam. Further, Pauletti teaches the method applicants used to produce the foam comprising incorporating the active agent with the polymer then creating the voids by freeze drying, and the active agent is released upon degradation of the polymer. This teaching implies the presence of the drug distributed in the wall of the foam, and released upon wetting the foam on use due to formation of pores. The proposed modification would not render the prior art invention being modified unsatisfactory for its intended purpose because the prior art still teaches foam comprising active agents present in the wall of the foam and releases active agent upon degradation of the foam as applicants had done. There is suggestion and motivation to make the proposed modification to achieve the claimed product.
Applicants argue that, if somehow, the purpose of the dissolvable members or dissolvable salt as intended by Patel was maintained, then these members or salt would not end up in the wall, as currently claimed, and the previously submitted arguments would have merit. That is, there are two states of the device taught by Patel: one state wherein the device does not yet contain pores and another state wherein pores are present, but the agents are located in the resulting pores and not in the wall. In other words, as herein argued, there is no state of the foam in which the foam contains a wall and pores. Rather, these pores do not contain agents, whilst the wall does.
In response to this argument, it is argued that there is one state during forming the foam wherein the device does not yet contain pores, and the active agent is present in the walls, and in the second state wherein pores are formed, the active agent is released from the wall passing through the pores to the site intended for delivery of the active agent at the site of application. Regardless how the pores are formed, the active agent is delivered from the wall passing through the pores to the desired site of delivery. After formation of the pores and before the active agent starts to be released, there is a state wherein the foam contains a wall comprising the active agent and pores. This is exactly what applicants had done, release of drug upon degradation of the foam. Further, Pauletti teaches the method applicants used to produce the foam comprising incorporating the active agent with the polymer then creating the voids by freeze drying, and the active agent is released upon degradation of the polymer. This teaching implies the presence of the drug distributed in the wall of the foam, and released upon wetting the foam on use due to formation of pores.
The rational to modify or to combine the prior art does not have to be expressly stated in the prior art; the rational may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve different problem. It is not necessary that the prior art suggest the combination or modification to achieve the same advantage or result discovered by applicant. In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972).
Obviousness does not require absolute predictability of success all that is required is a reasonable expectation of success. See In re Kubin, 561 F.3d at 1360. The Court has held that "the test of obviousness is not express suggestion of the claimed invention in any or all of the references but rather what the references taken collectively would suggest to those of ordinary skill in the art presumed to be familiar with them." See In re Rosselet, 146 USPQ 183, 186 (CCPA 1965). "There is no requirement (under 35 USC 103(a)) that the prior art contain an express suggestion to combine known elements to achieve the claimed invention. Rather, the suggestion to combine may come from the prior art, as filtered through the knowledge of one skilled in the art." Motorola, Inc. v. Interdigital Tech. Corp., 43 USPQ2d 1481, 1489 (Fed. Cir.1997). An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of a case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. See KSR Int'l Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) ("The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.").
Finally, it is well established that the claims are given the broadest interpretation during examination. A conclusion of obviousness under 35 U.S.C. 103 (a) does not require absolute predictability, only a reasonable expectation of success; and references are evaluated by what they suggest to one versed in the art, rather than by their specific disclosure. In re Bozek, 163 USPQ 545 (CCPA 1969).
In the light of the foregoing discussion, the Examiner’s ultimate legal conclusion is that the subject matter as a whole as defined by the claims would have been prima facie obvious within the meaning of 35 U.S.C. 103 (a).
Conclusion
THIS ACTION IS MADE FINAL. 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 Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached on Monday through Friday, 8:30 AM to 5:00 PM EST.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611
/I.G./