DETAILED ACTION
The receipt is acknowledged of applicants’ IDS, amendment and request for RCE, all filed 02/01/2025.
Claim 1-13 previously presented. Claims 5-6 have been canceled. Claims 1-4, and 7-13 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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/12/2025 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4, 7-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 recites at line 3 of the claim that “wherein steroidal anti-inflammatory agent is homogeneously mixed with the polymer”, and later the claim recites at line 7 that “adding chitosan and the steroidal anti-inflammatory agent to the polymer solution”. Therefore, the claim is confusing because it is not clear to the examiner if both chitosan and steroidal anti-inflammatory agents are added to the polymer solution at the same time to be homogeneously mixed in the polymer, or only the steroidal anti-inflammatory agent?
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 4 depends on claim 1, and claim 1 recites steroidal anti-inflammatory agent that is a species of the genus steroid. Claim 4 broadens the scope of claim 1 by reciting the genus “steroid” while claim 1 recites the species steroidal anti-inflammatory agent. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 7-12 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Pauletti et al. (WO 2004/041118), Hissink et al. (WO 2004/062704), as evidenced by the article by Kundu et al. “Development of porous HAp and B-TCP scaffolds by starch consolidation with foaming method and drug-chitosan bilayered scaffold based drug delivery system”, 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) and/or the article by Lavigne et al. (Steroid eluting sinus implant for in-office treatment of recurrent nasal polyposis: a prospective, multicenter study), and further combined with either the article by Valentine et al. (The efficacy of a novel chitosan gel on hemostasis after endoscopic sinus surgery in a sheep model of chronic rhinosinusitis) or Berman et al. (US 2014/0336147), all references are of record.
Applicant Claims
Claim 1 is directed to a process for the preparation of a drug eluting biodegradable foam comprising a polymer, chitosan and a steroidal anti-inflammatory agent, wherein the steroidal anti-inflammatory agent is homogeneously mixed with the polymer in the foam, wherein the polymer is a phase-separated polymer comprising at least one amorphous segment and at least one crystalline segment, wherein said foam is obtainable by a process comprising
- providing the polymer;
- dissolving the polymer in an organic solvent resulting in a polymer solution;
- adding chitosan and the steroidal anti-inflammatory agent to the polymer solution; and
- removing more than 95% of the solvent such that the foam is obtained
wherein a concentration of the polymer in the polymer solution is selected such that the foam has a porosity such that more than 95% of the drug is released in a period of at least 4 days.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
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 (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). The therapeutic agent can be anti-inflammatory agent (page 6, lines 25-26). The polymer comprises hydrophilic components, e.g. polyethylene, polyurethane (page 12, lines 16-20; page 18, line 26; page 26, lines 15-22). The process of making the polymer foam includes the steps of dissolving the appropriate polymer or mixture of hydrophilic polymers in a solvent and additives to form a solution of the polymer(s), or alternatively dissolving a mixture of the polymers and therapeutic agent(s) in a solvent and additive, or still further, solution of the polymer in solvent and additives is mixed with solution of the therapeutic agent in solvent and additives. The solvent used by the reference include cyclohexane and acetonitrile. The mixture is freeze dried to completely evaporate the solvent (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). Therapeutic agents include anti-inflammatory agents (page 35, lines 6-11). The additives include hydrophilic agent e.g. polyethylene glycol (page 32, line 35; page 33, line 1; page 34, line 20; claim 6).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Pauletti teaches the claimed method of making biodegradable polymer foam, Pauletti however does not teach the claimed phase-separated polymer comprising at least one amorphous segment and at least one crystalline segment as claimed by claim 1. The reference does not teach porosity of the foam as claimed by claim 1.
While Pauletti teaches therapeutic agent including anti-inflammatory agent incorporated in the biodegradable foam for application into body cavities, e.g. nasal cavity, and Hissink teaches hemostatic agent in the phase separating foam that useful for treating bleeding from body cavities including nasal cavities, the references however, are silent regarding steroidal anti-inflammatory drugs, and hemostatic chitosan as claimed by claim 1.
Hissink teaches biodegradable polymer foam for tissue regeneration and drug delivery purposes that can be applied at body antrum, e.g. nasal cavity, with advantage that it does not have to be mechanically removed (abstract; page 15, lines 22-25; page 16, lines 1-10; page 48, lines 28-30; claim 32). The biodegradable foam has enough strength to be readily handled in surgical procedures, comfortable, fits into any topography or space, resilient, and soft to avoid injury to sensitive tissues (page 3, lines 15-20). 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:
PNG
media_image1.png
58
447
media_image1.png
Greyscale
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; claims 1-3). The reference discloses impregnation of the foam with various substances that can be released upon wetting, such as hemostatic substances (page 37, lines 20-26). The reference teaches porosity of the biodegradable foam polymer preparation can be 85-99%, preferably 95-98% (page 21, lines 1-4; page 42, lines 27-28). The polymer can be prepared by process comprising forming solution of the polymer in 1,4-dioxane and completely remove the solvent by freeze drying the polymer solution, the dried polymer can be loaded with hemostatic agents and fillers (page 35, lines 3-26; page 36, lines 11-20; page 37, lines 10-26; examples).
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).
Valentine teaches chitosan significantly improves hemostasis agent after endoscopic sinus surgery, and showed significant decrease in in adhesion formation. Chitosan has the ability to initiate hemostasis independent on platelets or coagulation factors (see the entire document, and in particular the abstract and page 74, left column).
Berman teaches that chitosan is a well-known hemostatic agent and known for use in wound dressing and for direct application to open wound in the form of foam (¶ 0004). Chitosan can staunch bleeding from the nasal cavity (¶ 0034).
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 produce biodegradable polymer foam by the process taught by Pauletti, and use the biodegradable polymer taught by Hissink that comprises at least one amorphous segment and at least one crystalline segment for forming the foam that has porosity of the foam to 95-98%. One would have been motivated to do so because Pauletti desired to use the foam in the body cavities, e.g. nasal cavity, and Hissink teaches such phase separate polymer foam can be applied to the body cavities, e.g. nasal cavities 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, and soft to avoid injury to sensitive tissues. One would reasonably expect producing biodegradable phase separated polymer foam having porosity of 95-98% by the process of Pauletti wherein the foam is soft, resilient and safe to the surrounding tissues and suitable for use in the body cavities.
Further, one having ordinary skill in the art would have produced foam by the process taught by Pauletti that require removing the solvent, and completely remove the solvent as taught by Hissink to obtain the properties and porosity of the foam of Hissink.
Furthermore, 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 as taught by the combination of Pauletti and Hissink, as evidenced by Kundu, 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 producing biodegradable phase separating polymer foam comprising steroidal anti-inflammatory agent and hemostatic agent for use in the nasal cavity after surgery wherein healing and hemostasis of the nasal cavity after surgery is improved without the need of platelets or coagulation factors.
Additionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to produce biodegradable phase separating polymer foam comprising active agent including steroid anti-inflammatory agent and hemostatic agent for use in the nasal cavity as taught by the combination of Pauletti, Hissink, evidenced by Kundu, Hong and Lavigne, and use chitosan taught by Valentine and Berman as hemostatic agent. One would have been motivated to do so because Valentine teaches chitosan significantly improves hemostasis after endoscopic sinus surgery, and showed significant decrease in in adhesion formation, and has the ability to initiate hemostasis independent on platelets or coagulation factors, and because Berman teaches that chitosan is a well-known hemostatic agent and known for use in wound dressing and for direct application to open wound in a foam to staunch bleeding from the nasal cavity. One would reasonably expect producing biodegradable phase separating polymer foam comprising steroidal anti-inflammatory agent and chitosan for use in the nasal cavity after surgery wherein healing and hemostasis of the nasal cavity after surgery is improved without the need of platelets or coagulation factors.
Regarding the limitation of “homogeneously mixing steroidal anti-inflammatory agent with the polymer as claimed by claim 1, combination of the cited references, Pauletti in particular, teaches process of making the polymer foam includes the steps of dissolving the appropriate polymer or mixture of hydrophilic polymers in a solvent and additives to form a solution of the polymer(s), or alternatively dissolving a mixture of the polymers and therapeutic agent(s) in a solvent and additive, or still further, solution of the polymer in solvent and additives is mixed with solution of the therapeutic agent in solvent and additives. This teaching implies homogenous mixing of the active agent with the polymer.
Regarding the limitation of claim 1 that “wherein the foam has a porosity such that more than 95% of the drug is released in a period of at least 4 days”, it is noted that Hissink teaches porosity of the foam of 95-98% and exemplifies 96.4% and this is high porosity that achieved by applicants in page 4, lines 10-12, where applicants achieved porosity of 95-98%. Applicants stated that the higher the porosity, the higher the rate of drug release from the foam, page 4, lines 13-15. This is a known fact in the art as evidenced by Kundu that teaches that high porosity and high interconnectivity of pores in the scaffolds play a pivotal role in the drug release, and shows drug elusion from 4 to 42 days. The reference further teaches small drug molecules would release faster (see the entire document, and in particular the abstract; and paragraph 3.3). Hence, the prior art teaches the claimed drug eluting polymer foam having the same porosity, therefore, it is expected that the foam of the prior art would release the same amount of drug for the same period of time especially as evidenced by Kundu that the higher the porosity the higher the drug release for 4-42 days, based on the drug used and size of the drug molecules.
Regarding the limitation of claim 1 that “wherein the concentration of the polymer in the polymer solution is selected such that the foam has porosity …”, Hissink teaches 95-98% pores in the foam, this implies the rest of the foam is the polymer in concentration of 2-5%. Therefore, the concentration of polymer in the polymer solution controls the amount of pores, and if the prior art achieves the same amount of pores, then, the concentration of the polymer should be the same. This is because the prior art teaches the same process of drying to achieve pores.
Regarding claim 2 that the amorphous segment of the polymer comprises a hydrophilic segment, and claim 3 that the hydrophilic segment comprises poly(ethylene glycol), and regarding the formula of the phase separated polymer as claimed by claim 7, all are taught by Hissink.
Regarding steroids claimed by claim 4, they are taught by Hong and Lavigne.
Regarding claim 8 that the solvent is removed by freeze-drying, this is taught by both references.
Regarding claim 9 that mixing the drug and the polymer resulting in a drug-containing polymer solution, wherein said mixing is after adding at least one drug to the polymer solution and before removing the solvent, this is taught by the teachings of Pauletti.
Regarding the limitation of claim 10 of selecting a concentration of the polymer in the polymer solution to obtain a porosity of the foam of 85-99%, Hissink teaches porosity of the biodegradable foam polymer preparation can be 85-99% as claimed, and preferably 95-98%.
Regarding the solvents claims by claim 11, Hissink teaches 1,4-dioxane, and Pauletti teaches cyclohexane and acetonitrile.
Regarding claims 12 that loading the foam with a hydrophilic substance as additive, Pauletti teaches adding additives comprising hydrophilic materials, e.g. polyethylene glycol (PEG), to the solution of the polymer before freeze drying the solution to form foam, and that implies that the final foam is loaded with PEG. Further Hissink teaches loading the dried foam with hemostatic agent and filler after drying.
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 13 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Pauletti and Hissink, as evidenced by Kundu, combined with Hong or Lavigne, and further combined with Valentine or Berman, as applied to claims 1-4, 7-12 above, and further in view of any of the article by Agrawal et al. (Role of Polymeric Biomaterials as Wound Healing Agents) and Pesnell et al. (US 2013/0149343), all references are of record.
Applicant Claims
Claim 13 recites the hydrophilic additive substance of claim 12 is polyethylene glycol (PEG) and/or hygroscopic salt.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
The combined teachings of Pauletti and Hissink, as evidenced by Kundu, combined with Hong or Lavigne, and further combined with Valentine or Berman are previously discussed in this office action.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Pauletti teaches PEG as hydrophilic additives in the biodegradable foam, the reference however does not teach PEG with sufficient specificity to be used as additive in the foam.
Agrawal teaches polymeric biomaterials have great potential in the control of bleeding in severe trauma. PEG is a sealant to control hemorrhage and has the advantage of being cheap and easy to use and has good compatibility (see the entire document, and in particular the abstract; table 3, and page 183).
Pesnell teaches PEG can bind to hemostatic agents, e.g. thrombin and fibrinogen, to improve friability, wettability and performance of such hemostatic agents that are used for hemostatic treatment and wound sealing (abstract; ¶ 0015; claims).
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 produce biodegradable phase separating polymer foam comprising additive that can be PEG, and hemostatic agent for use in hemostasis as taught by the combination of Pauletti and Hissink, as evidenced by Kundu, combined with Hong or Lavigne, and further combined with Valentine or Berman, and definitely use PEG taught by Agrawal and Pesnell. One would have used PEG because Agrawal teaches the hemostatic effect of PEG and its potential to control bleeding while being cheap and easy to use and has good compatibility, and because Pesnell teaches PEG can bind to hemostatic agents, e.g. thrombin and fibrinogen, to improve friability, wettability and performance of such hemostatic agents that are used for hemostatic treatment and wound sealing. One would reasonably expect producing biodegradable phase separating polymer foam comprising hemostatic agent and PEG that is cheap, biocompatible and easy to use while effectively controls bleeding and seals the wound.
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 02/12/2025 have been fully considered but they are not persuasive.
Claim Rejections - 35 USC § 103
Applicants argue that Hong teaches that the triamcinolone is impregnated in the nasal packaging while present claim 1 requires that the steroidal anti-inflammatory agent is homogeneously mixed with the polymer by dissolving this agent in the solvent during the preparation process. In fact, Hong thus teaches the same process as Hissink is teaching i.e. impregnation (see, e.g., p. 38, 1. 22-25). the Office Action considered that the skilled person would have produced foam by the process taught by Pauletti to obtain the properties and porosity of the foam of Hissink (p. 8, first paragraph), and it is considered that it would have been obvious to replace the anti-inflammatory agent taught by Pauletti with a steroidal anti- inflammatory agent taught by either of Hong or Lavigne (p. 11, last paragraph). However, Hong teaches to impregnate the foam with a steroidal anti-inflammatory agent. Lavigne is silent on its implant is prepared.
In response to this argument, it is argued that Pauletti clearly teaches 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, or solution of the polymer in solvent and additives is mixed with solution of the therapeutic agent in solvent and additives. The mixture is freeze dried to completely evaporate the solvent (page 15, line 29 till page 16, line 24; page 23, line 12 till page 24 line 3). This teaching implies that the active agent is homogenously mixed with the polymer, and Pauletti in combination with the other cited references, e.g. Hong and Lavigne, teaches steroidal anti-inflammatory agent mixed with the polymer in solvent to produce homogenous mixture as claimed. The rejection is based on replacing the anti-inflammatory agent of Pauletti with steroidal anti-inflammatory agent of Hong or Lavigne, and not based on replacing any steps of Pauletti with those taught by Hissink or Hong. Therefore combination of the cited references teaches steroidal anti-inflammatory agent is homogeneously mixed with the polymer by dissolving this agent in the solvent during the preparation process. Not all the references need to teach all the claimed steps of the claimed method. The cited references are in the same field of endeavor and seek to solve the same problems as the instant application and claims, and one of skill in the art is free to select components available in the prior art, In re Winslow, 151 USPQ 48 (CCPA, 1966). Further, the examiner recognizes that references cannot be arbitrarily combined that there must be some reason why one skilled in the art would be motivated to make the proposed combination of primary and secondary references, In re Nomiya, 184 USPQ 607 (CCPA 1975). However, there is no requirement that a motivation to make the modification be expressly articulated.
Applicants argue that considering the aim to incorporate the steroidal anti-inflammatory agent of Hong in a foam of Hissink, the skilled person would be motivated to apply the process of preparation by these disclosures and to impregnate Hissink’s foam with Hong’s steroidal anti-inflammatory agent (as taught by both publications). The skilled person would not be prima facie motivated to apply the process of Pauletti, because this concerns a different foam and not a steroidal anti- inflammatory agent.
In response to this argument, it is argued that Hissink is relied upon for solely teaching the claimed phase separated polymer, and not for process of making the foam. It was known before the effective filing date of the present invention to prepare foam for controlled and sustained delivery of therapeutic agents to and through body cavities as the foam breakdown as taught by Pauletti. One having ordinary skill in the art would have used the method of Pauletti to produce any foam used to delivered active agent into body cavities, such as that steroidal anti-inflammatory agent taught by Hong. The rejection is based on replacing the anti-inflammatory agent of Pauletti with steroidal anti-inflammatory agent of Hong or Lavigne, and not based on replacing any steps of Pauletti with those taught by Hissink or Hong. It should be noted that the motivation to combine references can be different from the ones set forth by Applicant. That is, as long as motivation exists to combine the elements, the problem to be solved does not have to involve the same reason. As such, the examiner respectfully submits that there is motivation to include steroidal anti-inflammatory agent of Hong in the process of producing the foam by the process of Pauletti, absent evidence to the contrary
Applicants argue that both Berman and Valentine describe chitosan that has been reacted and modified before incorporation into a device. For example, Valentine disclose a chitosan gel that is prepared by cross-linking chitosan and dextran derivatives (see, e.g., p. 71). Valentine discloses to cross-link the chitosan with dextran. In present claim 1, the chitosan does not react with the polymer — which is clear from the fact that chitosan and the polymer are both defined as separate constituents of the foam. Similarly, Berman teaches to reacts the chitosan to hydrophobic moieties before utilizing these in a sponge (see, e.g., par. [0003] and claims 1 and 2. In contrast, the present claim recites to add chitosan and not the hydophobically modified chitosan of Berman.
In response to this argument, applicants attention is directed to the scope of the present claims that does not exclude modified or reacted chitosan. The claims’ language permits the presence of modified or reacted chitosan. Both references used chitosan for the purpose of hemostasis, as applicants had done. Both reference teach the hemostatic effect of chitosan by itself without modification or inclusion in a gel. Applicants failed to show any unexpected results obtained from chitosan per se versus its modifies form.
It is emphasized that the combination of the prior art references that teaches all the limitations of claim 1 including all the steps of the claimed process as well as the achieved product. In Alza Corp. v. Mylan Laboratories, Inc., 464 F.3d 1286, 80 USPQ2d 1001 (Fed. Cir. 2006), the court found that because the absorption properties of oxybutynin would have been reasonably predictable at the time of the invention, there would have been a reasonable expectation of successful development of a sustained- release formulation of oxybutynin as claimed. The prior art, as evidenced by the specification, had recognized the obstacles to be overcome in development of sustained-release formulations of highly water-soluble drugs, and had suggested a finite number of ways to overcome these obstacles. The claims were obvious because it would have been obvious to try the known methods for formulating sustained-release compositions, with a reasonable expectation of success. The court was not swayed by arguments of a lack of absolute predictability. Similarly, the examiner believes the present claims are reasonably expected from the cited prior art. Further, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Dillon, 919 F.2d at 697-98, 16 USPQ2d at 1905; In re Wilder, 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re Linter, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA1972).
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 Monday through Friday, 8:30 AM to 5:00 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./