DETAILED ACTION
The receipt is acknowledged of applicant’s amendment, terminal disclaimer, declaration under 37C.F.R. § 1.132, and IDS, all filed 03/02/2026.
Claims 1-29 previously presented. Claims 30-33 are currently added. Claims 1-33 are pending.
Claims 11-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention II and species (b), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/06/2025.
Claims 1-10 and 30-33 are subject of this office action.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/02/2026 and is being considered by the examiner.
Terminal Disclaimer
The terminal disclaimer filed on 03/02/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of copending application Serial Number 18/825,512 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Nonstatutory 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 1-10, 30-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,772,871. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims and the issued claims are directed to a common subject matter and any patent that will be issued on the present claims will be covered by the issued claims as follows: transdermal delivery patch comprising a drug layer affixed to a backing layer, wherein: the drug layer comprises from 2.5 mg to 3.5 mg dexmedetomidine, a pressure sensitive adhesive comprising a hydroxyl functionalized acrylate polymer, and lauryl lactate; the drug layer has an adhesive surface suitable for adhesion to a skin surface, wherein the patch provides average flux rate of 0.1-2 µg/cm2 (current claim 8). The issued claims recite by claim 19 average flux rate of 0.5-2 µg/cm2. The present claims are obvious over the issued claims.
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 1-10 and 30-33 are rejected under 35 U.S.C. 103 as being unpatentable over Pongpeerapat et al. (US 2015/0098982, IDS filed 6/10/2025).
Applicant Claims
Claim 1 is directed to transdermal delivery patch comprising a drug layer affixed to a backing layer, wherein:
the drug layer comprises from 2.5 mg to 3.5 mg dexmedetomidine, a pressure sensitive adhesive comprising a hydroxyl functionalized acrylate polymer, and lauryl lactate;
the drug layer has an adhesive surface suitable for adhesion to a skin surface, wherein the adhesive surface has a surface area from 11 cm2 to 13 cm2; and
the transdermal delivery patch is unitary in structure.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Pongpeerapat teaches transdermal drug delivery patch comprising dexmedetomidine (abstract; ¶¶ 0005, 0028). The reference teaches patch comprising dexmedetomidine in an amount ranges from 0.001-50 mg including 0.5-10 mg depending on the site of application and the intended use (¶¶ 0082, 0096-0097). The transdermal patch comprises backing layer, and single pressure adhesive drug containing layer, and siliconized polyester coated sheet (¶ 0127). The pressure adhesive layer comprises the drug, functionalized hydroxyl acrylate and permeation enhancer such as lauryl lactate (¶¶ 0102, 0103, 0110, 0114, 0116). The backing layer comprises polyethylene and polyethylene terephthalate (¶ 0115). The size of the transdermal delivery patch may vary, and range from 4 cm2 to 10,000 cm2, such as from 5 cm2 to 1000 cm2, and having a length from 1-100 cm and width from 1-60 cm depending on time of application (¶ 0113). The transdermal patch further has an average flux of the drug of 0.005 to 2.0 µg/cm2/hour (¶ 0078). The transdermal patch has a peak flux of the drug of 0.1 µg/cm2/hour or greater after 2 hours or more of applying the patch to the skin, e.g. 0.5, 1.0, 2.0 or 3.0 µg/cm2/hour (¶¶ 0072, 0074).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)&
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
While reference teaches all the elements of the claimed transdermal patch, the reference however does not teach a single embodiment with all the elements claimed by claim 1. As such, the instant prior art does not appear to provide sufficient specificity, i.e., involves some “picking and choosing” to give rise to anticipation. See, Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). That being said, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect.... the combination is obvious”. KSRv. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). Consistent with this reasoning, it would have been obvious to have selected the various combinations of features claimed from within the prior art disclosure, specifically transdermal patch comprising adhesive layer comprises the claimed amount of the drug, hydroxyl functionalized acrylate, and lauryl lactate, having the claimed size and the claimed backing layer.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to successfully formulate the claimed transdermal patch having the claimed structure from the teachings of Pongpeerapat.
Regarding the claimed amount of 2.5 mg to 3.5 mg dexmedetomidine as claimed by claim 1, and 2.6 to 3 mg as claimed by claim 2, the reference teaches 0.5-10 mg depending on the site of application and the intended use. The claimed amount falls within that taught by the reference. One having ordinary skill in the art would have determined the desired amount of the drug based on site of application, intended use and individual patient condition.
Regarding hydroxyl functionalized acrylate polymer, and lauryl lactate claimed by claim 1, both are taught by the reference.
Regarding surface area of the patch of 11 cm2 to 13 cm2 as claimed by claim 1 and 12 cm2 as claimed by claim 3, the claimed surface area falls within the surface area taught by the reference of 5 cm2 to 1000 cm2. One having ordinary skill in the art would have determined the size of the patch in light of the teaching of the reference that the size of the patch varies depending on time of application. Size of the patch would have been determined by one having ordinary skill in the art based on the specific intended use, duration of use of the patch, and individual patient needs.
Regarding the limitation of claim 1 that the transdermal delivery patch is unitary in structure, the reference teaches a unitary patch as claimed.
Regarding claim 4 that the claimed the drug layer comprises 2.92 mg dexmedetomidine and the adhesive surface has a surface area of 12 cm2, these two limitations are addressed above.
Regarding claim 5 that the transdermal delivery patch has a length of 3.5 cm to 4 cm and a width of 3 cm to 3.5 cm, the reference teaches length of 1-100 cm and width of 1-60 cm, and the claimed dimensions fall within that taught the reference. One having ordinary skill in the art would have determined the dimensions of the patch in light of the teaching of the reference that the size of the patch varies depending on duration of
Application, and it would be determined by one having ordinary skill in the art based on individual patient needs.
Regarding the release liner claimed by claims 6 and 7, the reference teaches silicone coated polyester as claimed.
Regarding the average flux as claimed by claim 8 of 0.1 to 2 µg/cm2/hour, the flux falls within that taught by the reference that teaches 0.005 to 2.0 µg/cm2/hour.
Regarding the peak flux as claimed by claim 9 of 0.1 to 3 µg/cm2/hour, the flux falls within that taught by the reference that teaches 0.1 µg/cm2/hour or greater.
Regarding claim 10 that peak flux is reached 2 hours or more after applying the transdermal patch to the skin, this is taught by the reference.
Regarding the measurement of flus using human cadaver as claimed by claims 8-10, the method of measuring is just an in vitro method of measurement that is not part of the claimed transdermal patch, and would not impart patentability to the claims.
Regarding all the claimed values by any of claims 1-10 above, the claimed values all fall within the values taught by the reference. 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 material of the backing layer comprises polyethylene and polyethylene terephthalate as claimed by claims 30-33, this is taught by the reference.
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 &
Declaration of Bert Berner Under C.F.R. § 1.132
Applicant's arguments filed 03/02/2026 have been fully considered but they are not persuasive.
Nonstatutory Double Patenting over U.S. Patent No. 10,772,871
Applicants traverse this obviousness double patenting rejection. In support of Applicant's position, Applicant submits the Declaration under 37 CFR § 1.132 of Dr. Bret Berner ("the Declaration"). As discussed in para. 5 of the Declaration, the instant application is based, in part, on the inventors' surprising discovery from a Phase II human clinical trial conducted in 2022-2023 that which evaluated the analgesic efficacy of the dexmedetomidine transdermal system ("DMTS") compared with placebo in subjects following abdominoplasty. In this study, the DMTS patch having a surface area of 12 cm² and 2.92 mg dexmedetomidine outperformed the DMTS patch having a surface area of 15 cm² and 3.65 mg dexmedetomidine in a number of pain treatment metrics as outlined in paragraphs 0443-0447 of the publication of the instant application. Applicant surprisingly discovered that subjects in the 12 cm² DMTS group demonstrated superior results. Overall these results demonstrated that the 12 cm² DMTS patch provided greater analgesia while providing a more favorable safety profile than the 15 cm² DMTS patch. These results were surprising and unexpected because the 12 cm² DMTS patch has less dexmedetomidine (2.92 mg) as compared to the 15 cm² patch (3.65 mg), but a lower amount of the analgesic dexmedetomidine would have been expected to lead to less analgesia, not greater analgesia. Declaration at paras. 5-7 (emphasis in original). Dr. Berner then goes on to state: “The results were surprising and unexpected also because both the 12 cm² DMTS patch and the 15 cm² DMTS patch have a dexmedetomidine amount-to-surface- area ratio of 0.243 mg/cm² and therefore were expected to exhibit similar dexmedetomidine release profiles and thus similar adverse effect/safety profiles. However, the 12 cm² DMTS unexpectedly exhibited a more favorable safety profile.”
In response to this argument and to paragraph 5-7 of the declaration, it is argued that the patch claimed by the issued patent provide the same effect as instant patch. For example, claim 8 of the issued patent recites the patch delivers 10-1000 µg/day of the drug, and current claim 8 recites 0.1-2 µg/cm2/hr. The amount recites by the current application is calculated to be 28.8-576 µg/day that falls within the amount delivered by the issued patent. Further claim 19 of the issued patent recites flux rate of 0.5-2.0 µg/cm2/hr that falls within the claimed flux rate. Furthermore, the issued claims recites by claim 14 that lauryl lactate is present in an amount of 1-5% and the present claims do not recite any amount of permeation enhancer, however disclosed in paragraph [0065] of the published application 0.01-20% permeation enhancer. Therefore, the present patch may have included the more amount of the permeation enhancer that resulted in the more drug delivery and better effects. It is further noted that the “comprising” language of the current claims’ language permits additional ingredients more than the claimed ingredients that may resulted in better analgesia than the issued claims. The current claims are therefore obvious over the issued claims. The comparison of the present claims and the issued claims appears to be unfair side by side comparison because the issued claims are “consisting of” only the drug, permeation enhancer and polymer, while the present claims are open ended and may contain additional ingredients that affect the drug flux and effect.
Applicants argue that, during the Examiner Interview conducted on November 21, 2025, the Examiner agreed that the data demonstrate superior effects with respect to a larger patch containing an amount of dexmedetomidine above the claimed range, but suggested providing supporting data for a patch having dexmedetomidine in an amount below the claimed range to establish the criticality of the upper and lower limits of the claimed range of the amount of dexmedetomidine. (Examiner Interview Summary, dated November 26, 2025). Therefore, Applicant herein provides data indicating that the claimed 12 cm² DMTS patch is more effective than a smaller DMTS patch containing dexmedetomidine in an amount below the claimed range to further support the superior performance of the patch presently claimed.
In response to this argument, it is noted that the declaration does not provide side by side comparison between the two compared patches in terms of their contents and amount of each ingredients in order to obtain fair side by side comparison. It is reiterated that the issued claims are limited to drug, enhancer and polymer as permitted by the “consisting of” language, and the present claims are open ended “comprising” language that permits additional ingredients that may affect the function and effect of the patch. The declaration includes statements which amount to an affirmation that the claimed subject matter functions as it was intended to function. This is not relevant to the issue of nonobviousness of the claimed subject matter and provides no objective evidence thereof. See MPEP § 716.
Applicants argue that, as discussed at para. 9 of the Declaration, Teikoku Pharma USA, Inc., who is the Applicant and assignee of the instant application, conducted a Phase II human clinical study in 2020 that is similar to the study described in the instant application but using a 6 cm² DMTS patch to determine the analgesic effect of DMTS compared with placebo in subjects undergoing abdominoplasty. The 6 cm² DMTS patch used in the 2020 Phase II study was formulated with 1.46 mg dexmedetomidine, which is below the presently claimed range (i.e., from 2.5 mg to 3.5 mg dexmedetomidine). Dr. Berner states: “the 6 cm² DMTS patch also had an amount-to-surface-area ratio of 0.243 mg/cm². Yet the present application] demonstrates that the claimed 12 cm² DMTS patch displayed superior therapeutic benefits, as compared to both the 6 cm² DMTS patch and the 15 cm² DMTS patch. This nonlinear 'inverted U' therapeutic dose response for DMTS could not have been predicted by any known data or studies regarding dexmedetomidine”. The 2020 clinical study results and highlight the superior performance of the 12 cm² DMTS patch as compared to the 6 cm² DMTS patch by pointing to certain data from the 2020 study and data in Table 19 of the present application. Dr. Berner states: “In the 2020 Phase II study, the time to first use of rescue medication was evaluated for patients administered the 6 cm² DMTS patch and patients administered a placebo. Table A, there was not a significant difference in the time to first use of rescue medication between the patients treated with a placebo patch (the median was 0.7 h after the surgery) and those with the 6 cm² DMTS patch (the median was 0.8 h after the surgery). In contrast, Table 19 of the '573 Application shows that the time to first use of rescue medication by the subjects who received the 12 cm² DMTS patch was about 4 times longer than the time to first use of rescue medication by the placebo group (the 12 cm² DMTS patch group waited 42 hrs and the placebo group waited 10.6 hrs after the surgery to use rescue medication). Table 19 shows that the time to first use of rescue medication by the subjects who received the 15 cm² patch was about 2 times longer than the time to first use of rescue medication by the placebo group (and thus 2 times faster than the 12 cm² DMTS patch group). The data corroborate the superior effectiveness of the 12 cm² DMTS patch as compared to the 6 cm² DMTS patch, which has surface area and amount of dexmedetomidine that fall below the presently claimed ranges, and to the 15 cm² DMTS patch, which has surface area and amount of dexmedetomidine that fall above the presently claimed ranges”.
In response to this argument and to paragraph 9 of the declaration, it is noted that applicants compared 6 cm2 patch with 12 cm2 patch, which is expected to have less effect, and applicants did not compare the lower limit of the claimed patch of 11 cm2, that can be 10.9 cm2 and the upper limit of the claimed patch of 13 cm2, that can be 13.1 cm2, in order to establish criticality of the claimed range of the patch size. Table A and Table 19 of the present specification do not establish criticality of the claimed patch size. Only showing that patch is working as it suppose to be working.
Applicants argue that in the Declaration at para. 10 and 11, Dr. Berner continues to discuss the results of the 2020 clinical study by pointing to additional data from the 2020 study and data in Table 17 of the present application. In particular, he states: “Furthermore, in the 2020 Phase II study, the proportion of subjects using rescue medication after the surgery was compared between the subjects administered the 6 cm² DMTS patch and the placebo group. Table B shows that the proportion of subjects using rescue medication was similar between the treatment groups when measured at both 0-12 hours after surgery and 0-96 hours after surgery (i.e., 83 vs. 85 events, or only a 2.4% difference). In comparison, Table 17 shows that the proportion of subjects using rescue medication is much less for the 12 cm² DMTS patch group (20% at 0-12 hours after the surgery and 32% at >12 hours) as compared to the placebo group (55.3% at 0-12 hours after the surgery and 56.5% at > 12 hours), and the difference VS. placebo is greater for the 12 cm² DMTS patch group than the 15 cm² DMTS patch group (31.6% at 0-12 hours after the surgery and 40.4% at >12 hours). These findings reinforce the unexpected advantages associated with the claimed DMTS patch of the specified surface area size and amount of dexmedetomidine.
In response to this argument, the arguments as in the previous sections are hereby repeated. To summarize: the data provided does not show the patch ingredients in the compared patches for the comparison to be fair, and the declaration includes statements which amount to an affirmation that the claimed subject matter functions as it was intended to function. This is not relevant to the issue of nonobviousness of the claimed subject matter and provides no objective evidence thereof. See MPEP § 716.
Rejection under 35 U.S.C. § 103 over US 2015/0098982
Applicants argue that, as set forth above, the instant application is directed to a novel transdermal dexmedetomidine patch defined by a particular surface area size and a particular amount of dexmedetomidine. The claimed patch provides unexpected and superior therapeutic outcomes that a skilled artisan could not have reasonably foreseen from the teachings of Pongpeerapat. Along with the additional data and arguments presented by Dr. Berner, as discussed above, Dr. Berner further states in para. 13 of the Declaration: “Pongpeerapat teaches that its patch may have a much larger size range of 4 cm² to 10,000 cm², i.e., 4 cm² to 1 m² (see para. 0113 of Pongpeerapat). This sprawling size range encompasses 6 cm², 12 cm², and 15 cm² patches and many more patch sizes. Yet, Pongpeerapat does not suggest that there is any particular size of importance with its broad range”. In para. 14 of the Declaration, Dr. Berner additionally states: “Likewise, Pongpeerapat teaches that the patch therein might include a much larger range of 0.001 mg to 50 mg of dexmedetomidine (paras. 0082 and 0096). This expansive range encompasses the 1.46 mg, 2.92 mg, and 3.65 mg amounts of the above-tested 6 cm², 12 cm², and 15 cm² DMTS patches, respectively. However, Pongpeerapat does not suggest that any dexmedetomidine amount within its large range might perform unexpectedly better than other amounts.
In response to this argument, and to paragraph 13 and 14 of the declaration, it argued that while the reference teaches broader range of the patch size, this range embraces the claimed size. Therefore, no sufficient specificity of the claimed range, and the range disclosed by the prior art constitute an anticipation of the claims. See, e.g., Atofina v. Great Lakes Chem. Corp, 441 F.3d 991, 999, 78 USPQ2d 1417, 1423 (Fed. Cir. 2006). However, In the instant case, the claimed range is not disclosed in the reference with "sufficient specificity” because the reference discloses broader. Therefore, the reference renders the claimed range of patch size obvious. It had been decided by Courts that the indiscriminate selection of "some" from among "many" is considered prima facie obvious. In re Lemin, 141 USPQ 814 (1964); National Distillers and Chem. Corp. V. Brenner, 156 USPQ 163. “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05. There is no evidence of record as to the criticality of the claimed ranges.
Further, the patch taught by the reference provides the same effect as instant patch. For example, the patch delivers 10-1000 µg/day of the drug, and current patch delivers 28.8-576 µg/day that overlaps with the amount delivered by reference. Further reference teaches flux rate of 0.5-2.0 µg/cm2/hr that falls within the claimed flux rate. Furthermore, the reference teaches lauryl lactate is present in an amount of 1-5% and the present claims do not recite any amount of permeation enhancer, however disclosed in paragraph [0065] of the published application 0.01-20%. Therefore, the present patch may have included more amount of the permeation enhancer that resulted in the more drug delivery and better effects. Further, the “comprising” language of the current claims’ language permits additional ingredients more than the claimed ingredients that may resulted in better analgesia than the reference. The comparison of the present claimed patch and the patch of the prior art appears to be unfair side by side comparison, as discussed above. because the issued claims are “consisting of” only the drug, permeation enhancer and polymer, while the present claims are open ended and may contain additional ingredients that affect the drug flux and effect.
Applicants argue that, without the benefit of impermissible hindsight, the skilled person would not have been motivated to pick and choose the particular combination of patch features within the broad disclosure of Pongpeerapat, as suggested by the Office Action, to develop the novel patch of the present application, and the skilled person would have had no expectation of the superior therapeutic properties exhibited by the instantly claimed patch. One of ordinary skill in the art would have had no reasonable expectation of successfully developing the claimed patch without the teachings of the present application or without understanding our surprising discovery based on human clinical trials as described in the Declaration.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the n case, it would have been obvious to one having ordinary skill in the art to select the desired patch size and the dose of the drug as claimed. The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain. In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir 1983). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments.
Further, as discussed above, the declaration does not make fair comparison with the prior art.
Finally, 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.").
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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 at 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./
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