DETAILED ACTION
The receipt is acknowledged of applicants’ amendments and request for RCE filed 09/11/2025.
Claims 1-3, and 8-14 previously presented. Claim 2 has been canceled. Claims 1, 3, 8-14 are pending and 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/18/2025 has been entered.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 8-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-25 of U.S. copending Application No. 16/382,652. The current claims and the copending claims are claiming common subject matter as follows: drug eluting biodegradable foam comprises a polymer and at least one drug that is homogeneously mixed with the polymer in the drug eluting biodegradable foam, wherein the polymer is a phase-separated polymer comprising at least one amorphous segment and at least one crystalline segment. The instantly claimed steroidal anti-inflammatory agent and a hemostatic agent are claimed by claim 25 of the copending application. The drug eluting polymer claimed by the referenced application is capable to deliver and release including hemostatic agent and a steroidal anti-inflammatory agent as instantly claimed. The copending claims anticipate/obviate the instant claims.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3, 8-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-13 of copending Application No. 17/529,591. The current claims and the copending claims are claiming common subject matter as follows: drug eluting biodegradable foam comprises a polymer and at least one drug that is homogeneously mixed with the polymer in the drug eluting biodegradable foam, wherein the polymer is a phase-separated polymer comprising at least one amorphous segment and at least one crystalline segment. The instantly claimed steroidal anti-inflammatory drug hemostatic agent are claimed by claim 4 of the copending application. The drug eluting polymer claimed by the referenced application is capable to deliver and release active agents including hemostatic agent and a steroidal anti-inflammatory agent as instantly claimed. The instantly claimed drug release is expected from the copending claims. The copending claims anticipate/obviate the current claims.
This is a provisional nonstatutory double patenting rejection.
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.
Claim 8 is 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. The claim is indefinite because it depends on canceled claim 2. In order to advance the prosecution the claim will be examined as depending on claim 1 since the limitation of canceled claim 2 is added to claim 1.
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, 3, 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over Pauletti et al. (WO 2004/041118, of record), Hissink et al. (WO 2004/062704, of record), combined with 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”, of record) or the article by Lavigne et al. (“Steroid eluting sinus implant for in-office treatment of recurrent nasal polyposis: a prospective, multicenter study” of record), and the combination above evidenced by the article by Kundu et al. (Development of porous HAp and β-TCP scaffolds by starch consolidation with foaming method and drug-chitosan bilayered scaffold based drug delivery system), and the above combination further combined with Chandrashekhar et al. (WO 2014/035245, currently provided).
Applicant Claims
Claim 1 is directed to a method for locally delivering and releasing a hemostatic agent and a steroidal anti-inflammatory agent to tissues and/or cavities of a patient over a period of 4 to 14 days, the method comprising:
- providing a drug eluting biodegradable foam that comprises a polymer and at least one drug that is homogeneously mixed with the polymer in the drug eluting biodegradable foam, wherein the polymer is a phase-separated polymer comprising at least one amorphous segment and at least one crystalline segment;
- placing said drug eluting biodegradable foam in a body cavity of the patient,
- allowing the drug eluting biodegradable foam to release 50% of the hemostatic agent and the steroidal anti-inflammatory agent over a period of 8 hours to 5 days and 95% - 100% of the hemostatic agent and the steroidal anti-inflammatory agent over a period of 4 to 14 days; and
- locally controlling bleeding by said delivery and release of the hemostatic agent in a body
cavity of the patient and treating inflammation by said delivery and release of the steroidal anti-
inflammatory agent in a body cavity of the patient’
wherein the hemostatic agent comprises chitosan.
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; page 35, lines 6-11). 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 to form a solution of the polymer(s), or alternatively dissolving a mixture of the polymers and therapeutic agent(s) in a solvent, or still further, solution of the polymer is mixed with solution of the therapeutic agent, then drying the mixture (page 15, line 29 till page 16, line 24). The formation of the mixture during the process of making the foam followed by drying implies that the therapeutic agents are present in the wall of the foam.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Pauletti teaches 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 claims 1 and 15.
While Pauletti teaches therapeutic agent including anti-inflammatory agent incorporated in the biodegradable foam for application into body cavities, e.g. nasal cavity, the reference is silent regarding steroidal anti-inflammatory agent and chitosan in the foam.
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 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 references teaches R can be lactide and Ɛ-caprolactone and teaches formula II (page 26). The reference teaches impregnation of the foam with various substances that can be released in a controlled rate upon wetting, such as hemostatic substances (page 37, lines 20-26). The reference teaches porosity of the biodegradable foam polymer preparation is 85-99%, preferably 92-98%, more preferably 95-98%, e.g. 96.4% (page 21, lines 1-6; page 42, lines 27-28).
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).
Chandrashekhar teaches hemostatic biodegradable foam composition comprising chitosan and phase separated polymer. The foam has porosity of 85-99%. The foam accelerates clotting process of blood when applied topically to the bleeding surface. The foam useful for hemostasis in body cavities even chitosan is used in small amount. (See abstract; page 1, lines 1-14; page 2, lines 20-25; page 3, lines 6-14)
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 polymer foam comprising anti-inflammatory therapeutic agent that can be applied to the nasal cavity and released at the site of application in a sustained release manner taught by Pauletti, and replace the biodegradable polymers forming the foam with the biodegradable polymer taught by Hissink that comprises at least one amorphous segment and at least one crystalline segment having porosity of 85-99%, and further add the hemostatic agent taught by Hissink. One would have been motivated to do so because Hissink teaches such phase separate polymer foam can be applied to the nasal cavity, 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, and deliver active agent in a controlled release rate. One would reasonably expect formulating biodegradable foam comprising phase separated polymer that is soft, resilient and safe to the surrounding tissues and suitable for use in the nasal cavity and having porosity of 85-99% and comprising therapeutic agent including anti-inflammatory agent and hemostatic agent that are released from the foam in a controlled release rate.
Further, 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 Pauletti and Hissink, 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.
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 foam comprising phase separated phase and hemostatic agent and steroidal anti-inflammatory agent to be locally delivered to body cavities, e.g. nasal cavity, as taught by the combination of Pauletti, Hissink, and either Hong or Lavigne, evidenced by Kundu, and replace the hemostatic agent by chitosan taught by Chandrashekhar. One would have been motivated to do so because Chandrashekhar teaches hemostatic foam composition comprising chitosan and phase separated polymer accelerates clotting process of blood when applied topically to the bleeding surface or in the body cavities in small amount. One would reasonably expect formulating biodegradable phase separating polymer foam comprising steroidal anti-inflammatory agent and chitosan to deliver the active agents in the body cavity, e.g. nasal cavity, after surgery wherein hemostasis is accelerated even with small amount of chitosan.
Regarding a method for locally delivering hemostatic agent and steroidal anti-inflammatory agents and hemostatic agent as claimed by claim 1, and the method for controlling bleeding and treat inflammation as claimed by claim 15, the claimed methods are taught and suggested by the combination of the cited references that teach locally applying drug eluting foam comprising hemostatic agent and steroidal anti-inflammatory agent that would expected to provide hemostasis and anti-inflammatory effect.
Regarding the claimed phase separating polymer foam claimed by claim 1, it is taught by Hissink, and both Pauletti and Hissink teach release of therapeutic agent from the foam; i.e. drug eluting foam.
Regarding hemostatic agent and steroid anti-inflammatory agent claimed by claim 1, Hissink teaches hemostatic agent, and both Hong and Lavigne teach steroid anti-inflammatory agents, and Chandrashekhar teaches the hemostatic agent is chitosan.
Regarding the limitation of claim 1 that “the drug eluting biodegradable foam to release 50% of the hemostatic agent and the steroidal anti-inflammatory agent over a period of 8 hours to 5 days and 95% - 100% of the hemostatic agent and the steroidal anti-inflammatory agent over a period of 4 to 14 days”, it is noted that Hissink teaches porosity of the foam of as claimed of 85-99% and this is high porosity that achieved by applicants in page 4, lines 23-26, where applicants achieved porosity of 95-98%, and applicants stated that the higher the porosity, the higher the rate of drug release from the foam, page 4, lines 17-19. 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. Kundu further teaches small drug molecules would be released 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 ingredients and 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 control bleeding and treat inflammatory conditions as claimed by claim 1, it is expected that the foam taught by the combination of the cited references comprising chitosan and steroidal anti-inflammatory agents to control bleeding and treat inflammation.
Regarding the functions of the foam as claimed by claim 3, they are all expected from the foam taught by combination of the cited references comprising the claimed ingredients.
Regarding control bleeding and treat inflammatory conditions as claimed by claim 8, it is expected that the foam taught by the combination of the cited references comprising chitosan and steroidal anti-inflammatory agents to control bleeding and treat inflammation.
Regarding claim 9 that the amorphous segment comprises hydrophilic segment, and claim 10 that the hydrophilic segment is polyethylene glycol, Hissink teaches these limitations of claims 9 and 10.
Regarding the formulae of the phased separated polymers claimed by claims 11 and 12, the claimed formula of phase-separated polymer are taught by Hissink.
Regarding claim 13 that the foam comprises voids and walls, and the drug is substantially located in the wall, the combination of the cited references teaches impregnation of the foam with the drug then drying the foam, and this implies that the drug would be present in the wall of the foam.
Regarding porosity of the foam between 85-99% as claimed by claim 14, Hissink and Chandrashekhar both teach the claimed porosity.
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 09/18/2025 have been fully considered but they are not persuasive.
Double Patenting Rejections
The examiner acknowledges Applicant’s request to hold in abeyance pending nonstatutory double patenting rejections till indication of allowable subject matter. Therefore, the rejections are maintained.
Claim Rejections — 35 USC § 103
Note that Valentine reference and Berman reference are no longer relied upon. However, for completeness of record the examiner will respond to applicant’s argument regarding these references.
Applicants argue that amended independent claim 1 specifies that the hemostatic agent comprises chitosan. According to the Examiner, the subject matter of the amended claim 1 (including the limitation from the canceled claim 2) would be novel over Pauletti, Hissink, and either Hong or Lavigne, as evidenced by Kundu. However, the feature of the hemostatic agent being chitosan would allegedly be obvious in further view of Valentine or Berman.
In response to this argument, it is argued that while including the chitosan of previous claim 2 in the combination of Pauletti, Hissink, and either Hong or Lavigne, however, as applicants themselves noted, the chitosan is obvious over Pauletti, Hissink, and either Hong or Lavigne, and further view of Chandrashekhar as set forth in this office action.
Applicants argue that Valentine teaches gel comprising chitosan/dextran gel with crosslinked chitosan and dextran derivatives (see, e.g., Valentine, page 72, first paragraph). Thus, the gel of Valentine essentially consists of crosslinked chitosan/dextran. Similarly, Berman merely discloses that the hemostatic agents, comprising hydrophobically-modified chitosan reverse micelles, may be in the form of foams or gels. Thus, Berman discloses foams or gels that essentially consist of the hemostatic agent.
In response to this argument, applicant’s attention is directed to the scope of the present claim 1 that recites “hemostatic agent comprising chitosan”. The claim languages permits chitosan/dextran taught by Valentine and micelles comprising chitosan taught by Berman. In formulating the rejection, the examiner did not include the crosslinked chitosan/dextran or miscellas of Berman into the foam, rather the examiner relied on the teaching of Valentine that chitosan significantly improves hemostasis after endoscopic sinus surgery, and showed significant decrease in adhesion formation, and has the ability to initiate hemostasis independent on platelets or coagulation factors. The examiner further relied on the teaching of Berman that chitosan is a well-known hemostatic agent and known for use in wound dressing and for direct application to open wound as a foam to staunch bleeding from the nasal cavity. The examiner only replaced the hemostatic agent taught by combination of Pauletti, Hissink, and either Hong or Lavigne, with only chitosan that has hemostatic effect.
Applicants argue that it is not obvious that chitosan can be released from a foam that does not essentially consist of chitosan, but also comprises a phase-separated polymer. Let alone that such a biodegradable foam allows for releasing the drug in a controlled claimed fashion, in which 50% of the hemostatic agent and the steroidal anti-inflammatory agent are released over a period of 8 hours to 5 days, and 95% - 100% of the hemostatic agent and the steroidal anti-inflammatory agent over a period of 4 to 14 days.
Therefore, the skilled person would not have a reasonable expectation of success in achieving the desired release profile by combining Pauletti, Hissink, and either Hong or Lavigne, as evidenced by Kundu, and further in view of Valentine or Berman.
This argument is moot in view of the newly cited reference to Chandrashekhar that teaches chitosan is released from phase separated foam. further combination of the cited references teaches all the elements of the claimed method, including the steps and used materials, and any results applicants achieved would be expected from the prior art foam since materials and their properties are inseparable, absent evidence to the contrary.
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."). The rationale to modify the prior art does not have to be expressly stated in the prior art; the rationale 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 and the reason to modify the reference may often suggest what the applicant has done.
A conclusion of obviousness does not require absolute predictability, only reasonable expectation of success, and references are evaluated by what they have suggested to one versed in the art rather than by their specific disclosure.
It is emphasized that the combination of the prior art references teaches all the limitations of claim 1 including all the steps method of using the claimed 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.
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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.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./