DETAILED ACTION
The receipt is acknowledged of applicants’ after final amendment filed 09/11/2025, and request for RCE filed 10/08/2025.
The amendment after final filed 09/11/2025 has been entered.
Claims 1, 9-12, 17-18, 21-29 are pending.
Claims 12, 18, 21-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention II and species, there being no allowable generic or linking claim. Election was treated as made without traverse in the reply filed on 01/04/2023.
Claims 1, 9-11, 17 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/08/2025 has been entered.
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 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, 9-11, 17 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of the article by Abualhasan et al. (“Synthesis and formulation of ibuprofen pro-drugs for enhanced transdermal absorption” of record), Hsu et al. (US 7,244,447, of record), and Chen et al. (WO 2012/151427, currently provided), and optionally further combined with Chaturvedi et al. (US 2015/0056192, of record), and Herschler (US 3,711,602, of record), all references are of record.
Applicant Claims
Claim 1 is directed to transdermal drug delivery system for topical application, comprising:
(a) an adhesive polymer matrix layer; and
(b) at least one ibuprofen prodrug dispersed within the adhesive polymer matrix layer; and
(c) a vehicle consisting of pharmaceutically acceptable permeation enhancer and/or penetration enhancer that is selected from dimethylsulfoxide (DMSO), polyethylene glycol 400 (PEG-400), or a combination thereof,
wherein the at least one ibuprofen prodrug is chemically and physically stable over a period of time of about 4 months to about 3 years within the vehicle;
wherein upon topical application of the transdermal drug delivery system to the skin or mucosa of a subject in need:
(i) the system releases a therapeutically effective amount of the at least one ibuprofen prodrug over a period of time of about 4 hours to about 30 hours; and
(ii) the at least one ibuprofen prodrug diffuses through the skin or mucosa of the subject to achieve therapeutic systemic levels of the at least one ibuprofen prodrug, wherein a permeation coefficient of the at least one ibuprofen prodrug in the transdermal drug delivery system is from about 33.32 to about 65.47 µg/h/cm2; and
wherein transdermal drug delivery system is in a non-aqueous, solid form and is a transdermal patch and the at least one ibuprofen prodrug has the structure of formula II:
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wherein R2 is ethyl.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Abualhasan teaches stable ibuprofen alkyl prodrugs for enhanced transdermal delivery. Ibuprofen prodrugs maintain their chemical, physical, microbial and biological stability during storage for at least 3 month at room temperature. Stability was checked at time interval of 0, 3, 6, 9 and 12 month. At 3 month interval stability was 99%. The reference teaches the claimed formula I of ibuprofen drug and teaches the claimed prodrug ethyl-ibuprofen. The reference teaches transdermal solution comprising ibuprofen-prodrug. (See the entire document). Having stability of 99% of ibuprofen prodrug at 3 month interval does not negate the drug is not stable after. However, it is expected to be still stable with decreasing degree of stability. No degree of stability is claimed.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Abualhasan teaches transdermal formulation comprising ibuprofen prodrug in a solution, the reference however does not teach transdermal device comprising polymer matrix and permeation enhancers as claimed by claim 1.
Hsu teaches transdermal administration of non-steroidal anti-inflammatory drugs (NSAIDs) that are known to be problematic when administered orally (abstract; col.1, lines 35-40). The reference teaches transdermal administration of NSAIDs and their prodrugs including ibuprofen (col.8, lines 17-33). Transdermal administration can be in any formulation, e.g. solution or delivery device (col.4, lines 8-15). Preferred is the transdermal delivery devices that can be affixed to skin (col.13, lines 20-27). The reference teaches transdermal delivery devices comprising polymeric adhesive matrix, backing layer, release liner, rate controlling membrane (col.13, line 19 till col.14, line 45). The drug is dispersed or suspended in a carrier (col.15, lines 36-330), i.e. dispersed or suspended in the adhesive. The polymer matrix comprises pressure sensitive adhesive including polyacrylate adhesives and the NSAID drug for long term contact to the skin (col.13, lines 29-43). Hsu teaches permeation enhancers including ethanol, polyethylene glycol (PEG) and dimethylsulfoxide (DMSO) (col.12, lines 30-55). The transdermal device has surface area ranging from 2-200 cm2, and preferably 5-100 cm2 and most preferably 20-60 cm2 (col.14, lines 55-58). The daily dose of NSAID is 200-1600 mg (col.16, lines 35-38). Figure 2 of the reference shows the transdermal patch releases therapeutic amount of ibuprofen over 4-24 hours. The reference teaches nonaqueous formulation (col.4, lines 20-25; col.10, lines 5-13).
Chen teaches transdermal formulation that overcomes poor transdermal penetration of ibuprofen by delivering ibuprofen from anhydrous transdermal formulation comprising permeation enhancer selected from PEG and DSMO. Ibuprofen includes salts and esters of ibuprofen, that are prodrugs. Ibuprofen is delivered transdermally for 24 hour. (abstract; ¶¶ 0004, 0005, 0011, 0018, 0023).
Chaturvedi teaches composition comprising NSAID drugs and prodrugs, e.g. ibuprofen (abstract; ¶¶ 0264-0265). The reference teaches transdermal patch for delivering the prodrug. The patch comprises matrix, backing layer, rate controlling membrane. The matrix comprising drug/prodrug dispersed in polymer adhesive matrix, and the matrix comprises penetration enhancer. The penetration enhancer can be PEG 400 (¶¶ 0338-0342, 0353).
Herschler teaches composition to increase topical administration of active agent to intact skin including anti-inflammatory drugs, the composition comprises dimethyl sulfoxide (DMSO) and (abstract; col.3 and 4).
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 deliver ibuprofen prodrug transdermally using stable topical solution as taught by Abualhasan, and replace the topical/transdermal formulation with transdermal delivery device comprising adhesive polymeric matrix comprising PEG and/or DMSO as taught by Hsu. One would have been motivated to do so because Hsu teaches that ibuprofen can be delivered equally and successfully from any topical formulation including solution and transdermal delivery devices, and the devices are preferred because they can be affixed to the skin for long term contact while avoiding problems of oral administration. One would reasonably expect formulating transdermal device comprising polymeric adhesive matrix comprising ibuprofen prodrug and PEG and/or DMSO affixed to the skin for long period and safely and successfully deliver ibuprofen prodrug to the patient in need of ibuprofen treatment without any problems that associate with the oral delivery.
Further, it would have been obvious it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide transdermal patch comprising adhesive polymeric matrix comprising ibuprofen prodrug and permeation enhancer including PEG and/or DMSO as taught by the combination of Abualhasan and Hsu, and use PEG and/or DMSO taught by Chen in the adhesive matrix because Chen teaches suitability of both permeation enhancers to overcome poor transdermal permeation of ibuprofen and its prodrugs from anhydrous transdermal formulation.
Furthermore, it would have been obvious it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide transdermal patch comprising adhesive polymeric matrix comprising ibuprofen prodrug and permeation enhancer including PEG and/or DMSO as taught by the combination of Abualhasan, Hsu and Chen, and replace PEG with PEG-400 taught by Chaturvedi, and/or use DMSO taught by Herschler. One would have been motivated to do so because Chaturvedi teaches suitability of PEG-400 as permeation enhancer in adhesive matrix of transdermal patch comprising NSAID prodrug, and Herschler teaches DMSO in topical composition increases topical administration of active agent to intact skin including anti-inflammatory drugs. One would reasonably expect formulating a transdermal patch comprising adhesive matrix comprising prodrug of ibuprofen and PEG-400 and/or DMSO wherein the prodrug effectively permeates through intact skin.
Regarding the structure of ibuprofen prodrug as claimed by claim 1, Abualhasan teaches the claimed structure of ibuprofen prodrug. The structure of ibuprofen prodrug is not separable from the prodrug and it is taught by Abualhasan.
Regarding release of therapeutically effective amount of ibuprofen for 4-30 hours as claimed by claim1, Hsu teaches ibuprofen release for 4-24 hours that falls within the claimed period of time. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Regarding the drug is dispersed in the polymer matrix as claimed by claim 1, this is taught by Hsu that teaches drug dispersed or suspended in a carrier. Based on the carrier used, and solubility of ibuprofen in such a carrier, dispersion is expected specially Hsu teaches the claimed polyacrylate adhesive matrix as carrier in transdermal devices.
Regarding the claimed permeation enhancers claimed by claim 1, Hsu teaches both PEG and DMSO, and Chaturvedi teaches PEG-400, and Herschler teaches DMSO.
Regarding the expression “consisting of PEG and DMSO”, It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art. See In re kerkhoven 205 USPQ 1069, 1072. Applicants failed to show unexpected results obtained from permeation enhancer consisting of PEG and DMSO. Further, the open language of the claimed transdermal patch permits the presence of other ingredients that can be used as permeation enhancer or can be added for other purpose other than increase drug permeation.
Regarding diffusion of the drug through the skin or mucosa to achieve the therapeutic systemic level as claimed by claim 1, diffusion through skin or mucosa is an expected function from combination of the cited references since the combination teaches transdermal device and the therapeutic effective plasma level is achieved for 24 hours as taught by Hsu.
Regarding claim 1 that the transdermal patch is solid non-aqueous form, combination of the cited references suggests solid adhesive matrix as claimed.
Regarding stability of ibuprofen as claimed by claim 1, this is taught by Abualhasan.
Regarding the claimed permeation coefficient claimed by claim 1, the combination of the cited references teaches the instantly claimed transdermal non-aqueous formulation comprising the claimed adhesive polymer matrix comprising ibuprofen prodrug, and the claimed permeation enhancers, and it is expected that the transdermal permeation of ibuprofen prodrug in the transdermal drug delivery taught by the combination of the cited references to be the same as claimed since material and their properties cannot have exclusive characteristics, absent evidence to the contrary.
Regarding period of stability of 4 month to 3 years as claimed by claim 1, Abualhasan teaches 99% stability at 3 month. After 3 month the drug not expected to be unstable immediately, stability might drop but the drug will be still considered stable for more time. No degree of stability is claimed, and in view of the term “about 4 month” of the claims, the stability taught by the reference is close enough to the claimed stability. Combination of the cited references teaches the instantly claimed device comprising the same polymer matrix and permeation enhancer, and the period of stability of the device and the polymer matrix is expected to be the same as claimed since materials and their properties are inseparable.
Regarding R2 is ethyl as claimed by claim 1, this is taught by Abualhasan.
Regarding claim 9 that he transdermal patch comprises backing layer, release liner or rate controlling membrane, all taught by Hsu.
Regarding claim 10 that recites the adhesive matrix material, Hsu teaches polyacrylate pressure sensitive adhesive polymer.
Regarding the amount of the prodrug in the polymer matrix of 200-2550 mg as claimed by claim 11, Hsu teaches 200-1600 mg/day that falls within the claimed amounts. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Regarding the size of the patch as claimed by claim 17 of 1-20 cm2, Hsu teaches 2-200 cm2, and preferably 5-100 cm2 and most preferably 20-60 cm2 that all overlap with the claimed sizes. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
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 09/11/2025 have been fully considered but they are not persuasive.
Rejections Under 35 U.S.C. § 103
The Rejection Rational
Applicants disagree with the office action that “it would have been obvious to one having ordinary skill in the art .. . to deliver [an] ibuprofen prodrug transdermally using a stable topical solution as taught by Abualhasan, and replace the topical/transdermal formulation with transdermal delivery device comprising adhesive polymeric matrix comprising PEG and/or DMSO as taught by Hsu.” The Office Action plainly acknowledges that Abualhasan does not provide a transdermal device comprising a polymer matrix and permeation enhancers, as presently claimed. To close this fundamental gap in teaching, the Office Action turns to Hsu and asserts that there would have been motivation because “Hsu teaches that ibuprofen can be delivered equally and successfully from any topical formulation including solution and transdermal delivery devices, and the devices are preferred because they can be affixed to the skin for long term contact while avoiding problems of oral administration”. Lastly, the Office Action additionally cites Chaturvedi and Herschler as providing motivation to use “PEG-400 taught by Chaturvedi and/or use DMSO taught by Herschler.”
In response to this argument, applicant’s attention is directed to the scope of the present claims that are directed to a product, and all the elements of the claimed product are taught by combination of the cited references. Stability of ibuprofen prodrug is intrinsic property of the prodrug, that is recognized by the art, e.g. Domb, previously cited by the examiner, that teaches: “Prodrugs have advantages over the drug from they are derived, and have different physical and chemical properties for formulation purposes including greater stability, improved longevity, increased absorption, with less topical irritability and increased bioavailability when administered to the skin.” Hsu is relied upon for teaching the structure of the claimed transdermal patch. Chaturvedi and Herschler are relied upon for teaching specific permeation enhancers. 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 combine the cited references to achieve ibuprofen prodrug in a transdermal polymeric matrix comprising permeation enhancers that is stable for long period of time. 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, even for a different reason.
B. The combination of the cited references as alleged by the Office would not arrive at the present claims.
1. In contrast to the claimed invention, Albualhasan is limited to ibuprofen alkyl ester prodrugs
Applicants argue that Abualhasan is directed to ibuprofen alkyl ester prodrugs, and only teaches formulations of the ibuprofen alkyl ester prodrugs as a topical solution and is completely devoid of any disclosure related to the alkyl ester prodrug used in any other type of formulation, such as a transdermal patch. The topical formulations of Abualhasan include ibuprofen or butyl- ibuprofen, isopropyl alcohol, and isopropyl palmitate. See, e.g., Table 1. Abualhasan does not teach or suggest the presently claimed ibuprofen prodrug having the structure of formula I formulated with a vehicle consisting of DMSO, PEG-400, or a combination thereof in a transdermal patch.
In response to this argument it is argued that Abualhasan teaches the instantly claimed ibuprofen prodrug having the structure of formula II. Table 2 teaches ethyl ibuprofen. Combination of Abualhasan with the secondary references would have suggested transdermal patch comprising the claimed prodrug in an adhesive nonaqueous matrix formulation and comprising the claimed permeation enhancers. One having ordinary skill in the art would have replaced the transdermal formulation in the form of solution taught by Abualhasan with other transdermal formulations taught by Hsu because Hsu teaches equivalency between transdermal formulations including solution, lotion, patch, etc., and also teaches both aqueous and nonaqueous formulations, in terms of delivering ibuprofen transdermally. Hsu further teaches the advantages of the transdermal patch over other formulations. If Abualhasan was to teach transdermal patch, the reference would have considered for anticipation. Further, it is noted that applicants argue against Abualhasan individually while obviousness is based on combination of the cited references. PEG and DMSO are taught by combination of the other cited references and no need to be taught by each reference.
2. Hsu does not remedy the deficiencies of Abualhasan
Applicants argue that Hsu teaches formulations of a nonsteroidal anti-inflammatory drug with a hydroxide-releasing agent to enhance the flux of the drug through the body surface without causing damage thereto. See, e.g., column 3, lines 27-25. Hsu defines a hydroxy-releasing agent as “an agent that releases free hydroxide ions in an aqueous environment.” See, e.g., column 5, lines 32-34.
In response to this argument, it is argued that Hsu clearly teaches transdermal formulations can be equally aqueous or nonaqueous. Chaturvedi teaches the use of PEG-400 and Herschler teaches the use of DMSO as permeation enhancers without the need of hydroxide releasing agent in any of the references. Applicant’s attention is directed to the expression “transdermal drug delivery patch comprising” of the claims’ language, the expression does not exclude the presence of any other ingredients, active or inactive, even in major amounts, e.g. hydroxide releasing agent that can be added for reasons other than permeation enhancing. The transitional term “comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) (“like the term ‘comprising,’ the terms ‘containing’ and ‘mixture’ are open-ended.”). Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003) (“The transition ‘comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps.”); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) (“Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) (“comprising” leaves “the claim open for the inclusion of unspecified ingredients even in major amounts”). In Gillette Co. v. Energizer Holdings Inc., 405 F.3d 1367, 1371-73, 74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005), the court held that a claim to “a safety razor blade unit comprising a guard, a cap, and a group of first, second, and third blades” encompasses razors with more than three blades because the transitional phrase “comprising” in the preamble and the phrase “group of” are presumptively open-ended. “The word ‘comprising’ transitioning from the preamble to the body signals that the entire claim is presumptively open-ended.” Id. In contrast, the court noted the phrase “group consisting of” is a closed term, which is often used in claim drafting to signal a “Markush group” that is by its nature closed. The court also emphasized that reference to “first,” “second,” and “third” blades in the claim was not used to show a serial or numerical limitation but instead was used to distinguish or identify the various members of the group.
Applicants argue that, although Hsu lists examples of other compounds that have been used for enhancing the permeability of skin, e.g. DMSO and PEG, Hsu teaches that there is a need for enhancers that are highly effective in increasing the rate at which an NSAID permeates through the skin without resulting in skin damage, irritation, sensitization, or the like, and that hydroxide-releasing agents are highly effective at achieving such advantages. See, e.g., column 1, lines 51-65. Thus, none of the formulations of Hsu include DMSO, PEG-400, or a combination thereof. See, e.g., Example 3 of Hsu. Accordingly, Hsu does not teach or suggest a transdermal drug delivery system comprising the claimed ibuprofen prodrug having the structure of formula II formulated with a vehicle consisting of DMSO, PEG-400, or a combination thereof in a transdermal patch, and where the permeation coefficient of the at least one ibuprofen prodrug in the transdermal drug delivery system is from 33.32 - 65.47 µg/h/cm2.
In response to this argument, it is argued that Hsu clearly teaches transdermal adhesive matrix comprising the claimed permeation enhancers. As discussed above, the claims’ language permits the presence of hydroxide releasing agent taught by Hsu. If Hsu was to teach the claimed transdermal drug delivery system comprising the claimed ibuprofen prodrug having the structure of formula II formulated with a vehicle consisting of DMSO, PEG-400, the reference would have been an anticipatory references. Regarding the claimed coefficient of the at least one ibuprofen prodrug in the transdermal drug delivery system is from 33.32 - 65.47 µg/h/cm2, as claimed, it is argued the combination of the cited references teaches the instantly claimed transdermal non-aqueous formulation comprising the claimed adhesive polymer matrix comprising ibuprofen prodrug, and the claimed permeation enhancers, and it is expected that the transdermal permeation of ibuprofen prodrug in the transdermal drug delivery taught by the combination of the cited references to be the same as claimed since material and their properties cannot have exclusive characteristics, absent evidence to the contrary.
Further, it is noted that applicant argues against Hsu reference individually, while obviousness is based on combination of references. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
3. Chaturvedi and Herschler do not remedy the deficiencies of the other references
Applicants argue that Chaturvedi and Herschler were merely relied on for their teachings of PEG-400 and DMSO, respectively, and do not cure the deficiencies of Abualhasan, and Hsu, alone or in combination.
In response to this argument, both Chaturvedi and Herschler satisfied the purpose for which they were applied as set forth in this office action.
Finally, the 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.").
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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/ISIS A GHALI/
Primary Examiner, Art Unit 1611 /I.G./