Docket No.: 888968004US10
`(PATENT)
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent Application of:
`Manku et al.
`
`Application No.: 13/768,906
`
`Confirmation No.: 4793
`
`Filed: February 15, 2013
`
`For: STABLE PHARMACEUTICAL
`COMPOSITION AND METHODS OF USING
`SAME
`
`Art Unit: 1615
`
`Examiner: A. Sasan
`
`AMENDMENT IN RESPONSE TO
`NON-FINAL OFFICE ACTION UNDER 37 C.F.R. 1.111
`
`MS Amendment
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Madam:
`
`INTRODUCTORY COMMENTS
`
`In response to the Office Action dated May 24, 2013, please amend the above(cid:173)
`
`identified U.S. patent application as follows:
`
`Amendments to the Claims are reflected in the listing of claims which begins on
`
`page 2 of this paper.
`
`Remarks/Arguments begin on page 5 of this paper.
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`Application No. 13/768,906
`Reply to Office Action of May 24, 2013
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`Docket No.: 888968004US10
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`AMENDMENTS TO THE CLAIMS
`
`This listing of Claims will replace all prior versions, and listings, of Claims in the
`
`application:
`
`1.
`
`(Currently amended) A method of reducing triglycerides in a subject
`
`with
`
`treating mixed dyslipidemia
`
`in a subject on statin
`
`therapy comprising,
`
`administering to the subject a pharmaceutical composition comprising about 2500 mg
`
`to 5000 mg per day of ethyl eicosapentaenoate and not more than about 5%...___Qy
`
`weight of all fatty acids, docosahexaenoic acid or its esters, by v,eight of all fatty
`
`acids, to effect a reduction in of at least 10% fasting triglyceride levels in the subject
`
`and a reduction in LDL C compared to placebo control.
`
`2.
`
`(Original) The method of claim 1 wherein upon 12 weeks of said
`
`administration the subject exhibits a reduction in LDL-C of at least 5% compared to
`
`placebo control.
`
`3.
`
`(Original) The method of claim 1 wherein the subject exhibits a reduction
`
`in fasting triglycerides of at least 15% compared to placebo control.
`
`4.
`
`(Original) The method of claim 1 wherein upon 12 weeks of said
`
`administration the subject exhibits a reduction in fasting triglycerides of at least 20%
`
`compared to placebo control.
`
`5.
`
`(Original) The method of claim 1 wherein upon 12 weeks of said
`
`administration the subject exhibits a reduction in fasting triglycerides of at least 25%
`
`compared to placebo control
`
`6.
`
`(Original) The method of claim 1 wherein the subject exhibits a reduction
`
`in fasting VLDL-C compared to placebo control.
`
`7.
`
`(Original) The method of claim 1 wherein the subject exhibits a reduction
`
`in fasting VLDL-C of at least 5% compared to placebo control.
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`Application No. 13/768,906
`Reply to Office Action of May 24, 2013
`
`Docket No.: 888968004US10
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`8.
`
`(Original) The method of claim 1 wherein the subject exhibits a reduction
`
`in hs-CRP compared to placebo control.
`
`9.
`
`(Original) The method of claim 1 wherein
`
`the subject exhibits a
`
`reduction in non-HDL-C compared to placebo control.
`
`10.
`
`(Original) The method of claim 1 wherein
`
`the subject exhibits a
`
`reduction in total cholesterol compared to placebo control.
`
`11.
`
`(Original) The method of claim 1 wherein
`
`the subject exhibits a
`
`reduction in non-HDL-C, total cholesterol and VLDL-C compared to placebo control.
`
`12.
`
`(Original) The method of claim 1 wherein
`
`the subject exhibits a
`
`reduction in oxidized LDL-C compared to placebo control.
`
`13.
`
`(Original) The method of claim 1 wherein
`
`the subject exhibits a
`
`reduction in lipoprotein associated phospholipase A2 compared to placebo control.
`
`14.
`
`(Original) The method of claim 1 wherein the ethyl eicosapentaenoate is
`
`administered to the subject in dosage units each comprising about 500 mg to about
`
`1.5 g of ethyl eicosapentaenoate.
`
`15.
`
`(Original) The method of claim 14 wherein
`
`the dosage units are
`
`capsules.
`
`16.
`
`(Original) The method of claim 1 wherein the ethyl eicosapentaenoate is
`
`administered to the subject in dosage units each comprising about 900 mg to about 1
`
`g of ethyl eicosapentaenoate.
`
`17.
`
`(Original) The method of claim 16 wherein the ethyl eicosapentaenoate
`
`is administered
`
`to the subject in dosage units each comprising about 1 g of ethyl
`
`eicosapentaenoate.
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`Application No. 13/768,906
`Reply to Office Action of May 24, 2013
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`Docket No.: 888968004US10
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`18.
`
`(Original) The method of claim 17 wherein
`
`the dosage units are
`
`capsules.
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`19.
`
`(Original) The method of claim 1 wherein the ethyl eicosapentaenoate
`
`comprises at least about 90%, by weight, of all fatty acids.
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`Application No. 13/768,906
`Reply to Office Action of May 24, 2013
`
`Docket No.: 888968004US10
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`REMARKS
`
`Reconsideration of this application is respectfully requested. At the time the
`
`present Office Action was mailed (May 24, 2013), claims 1-19 were pending. Claims 1-
`
`19 are rejected. Claim 1 has been amended. No new matter has been added. Claims
`
`1-19 are now pending in this application.
`
`Claim Rejections Under 35 U.S.C. § 103
`
`Claims 1-12 and 14-19 are rejected under 35 U.S.C. § 103(a) as allegedly being
`
`unpatentable over Katayama et al. (Prog. Med. 2001; 21 :457-467 - English Translation)
`
`("Katayama") in view of Davidson et al. (Clinical Therapeutics Vol. 29, Number 7, 2007,
`
`pp. 1354-1367) ("Davidson") and Saito et al. (Atherosclerosis 200 (2008) 135-140)
`
`("Saito").
`
`Claim 13 is rejected under 35 U.S.C. § 103(a) as allegedly being unpatentable
`
`over Katayama in view of Davidson, Saito and Anderson (The American Journal of
`
`Cardiology, 2008; 101 :23F-33F) ("Anderson").
`
`Claims 1-12 and 14-19 are rejected under 35 U.S.C. § 103(a) as allegedly being
`
`unpatentable over U.S. Patent Publication No. 2007-0191467 to Rong en et al.
`
`("Rongen") in view of Saito.
`
`Claim 13 is rejected under 35 U.S.C. § 103(a) as allegedly being unpatentable
`
`over Katayama in view Rongen in view of Saito and Anderson. Applicants respectfully
`
`traverse each of the foregoing rejections.
`
`I.
`
`Rejections over Katayama, Davidson, Saito and Anderson.
`
`To establish a prima facie case of obviousness under 35 U.S.C. § 103, the Office
`
`must articulate a reason or rationale that would have prompted a person of ordinary skill
`
`in the relevant field to combine the elements in the way the claimed new invention does.
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`Application No. 13/768,906
`Reply to Office Action of May 24, 2013
`
`Docket No.: 888968004US10
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`See, e.g., KSR Int'/ Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741-1742 (2007). One
`
`rationale commonly employed by the PTO (as in this case) is that an applicant is
`
`combining prior art elements according to known methods to yield predictable results.
`
`MPEP 2143A. To reject a claim on this rationale, the Office must resolve the Graham
`
`factual inquiries, and then articulate the following:
`
`(1) a finding that the prior art included each element claimed, although not
`
`necessarily in a single prior art reference, with the only difference between the
`
`claimed invention and the prior art being the lack of actual combination of the
`
`elements in a single prior art reference;
`
`(2) a finding that one of ordinary skill in the art could have combined the
`
`elements as claimed by known methods, and that in combination, each element
`
`merely performs the same function as it does separately;
`
`(3) a finding that one of ordinary skill in the art would have recognized that the
`
`results of the combination were predictable; and
`
`(4) whatever additional findings based on the Graham factual inquiries may be
`
`necessary, in view of the facts of the case under consideration, to explain a
`
`conclusion of obviousness.
`
`If any of these findings cannot be made, this rationale cannot be used to support
`
`a conclusion that the claim would have been obvious to one of ordinary skill in the art.
`
`Id. As will be discussed in detail below, Applicant respectfully submits that in the instant
`
`case, the results of the claimed invention were not predictable.
`
`In respect of the predictability/reasonable expectation of success prong, the
`
`Office Action at page 5 states that "[t]he result of achieving a reduction in LDL-C
`
`compared to placebo control would have been expected based on the teaching by Saito
`
`et al. unless there is evidence of criticality or unexpected results." Applicants
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`Application No. 13/768,906
`Reply to Office Action of May 24, 2013
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`Docket No.: 888968004US10
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`respectfully disagree and submit that one could not reasonably expect success in
`
`reducing LDL-C compared to placebo control subjects.
`
`Saito administered ~ 1.8 g per day of E-EPA (Epadel) to subjects taking a statin
`
`or in a control arm administered statin without E-EPA. Saito observed a relative
`
`increase in LDL-C of 2% for Epadel + statin as compared with subjects receiving statin
`
`alone (control). Specifically, Saito's control group showed a 22% mean reduction in
`
`LDL-C compared to baseline whereas Saito's active treatment group (statin + E-EPA;
`
`referred to by Saito as the "EPA group") showed only a 20% reduction in LDL-C.
`
`Therefore, the addition of E-EPA to a statin in Saito produced a less favorable LDL-C
`
`lowering profile than was seen in the statin-only arm. That is, statin alone (control)
`
`reduced LDL-C more than statin plus Epadel (active treatment).
`
`Contrary to the conclusion in the Office Action, Saito does not provide a
`
`reasonable expectation of success in reducing LDL-C compared to placebo control.
`
`If
`
`anything, Saito would create an expectation of no change or an increase in LDL-C
`
`compared to placebo control. Katayama and Davidson do not cure the defects of Saito.
`
`Katayama did not treat subjects receiving statin therapy and Davidson teaches that
`
`adding omega-3 fatty acid esters to statin therapy results in an increase in LDL-C
`
`compared to statin plus placeo--a 5.3% increase (P=0.52 as shown in Table II of
`
`Davidson).
`
`Nor does Anderson cure the defects in the prima facie case. Anderson merely
`
`discloses that Lp-PLA2 is an
`
`independent predictor of coronary artery disease.
`
`Because the "reasonable expectation of success" prong of the prima facie case is not
`
`met for any of the pending claims, no prima facie case of obviousness has been
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`established. Withdrawal of the rejection is respectfully requested.
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`Application No. 13/768,906
`Reply to Office Action of May 24, 2013
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`II.
`
`Unexpected LDL-C Reduction
`
`Docket No.: 888968004US10
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`Applicants respectfully submit that even if a prima facie case of obviousness has
`
`been established
`
`(which
`
`it has not), Applicants present herewith evidence of
`
`unexpected reductions of LDL-C observed in the ANCHOR trial.
`
`The results of the ANCHOR study are published in Ballantyne et al., Efficacy and
`
`Safety of Eicosapentaenoic Acid Ethyl Ester (AMR101) Therapy in Statin-Treated
`
`Patients With Persistent High Triglycerides (from the ANCHOR study) American Journal
`
`of Cardiology Vol. 110, Issue 7, Pages 984-992. AMR101 is also known as Vascepa®
`
`Overall, Vascepa® 4 g/day decreased LDL cholesterol by 6.2% (p = 0.0067) and
`
`reduced apoB by 9.3% (p < 0.0001 ), total cholesterol by 12.0% (p < 0.0001 ), very-low(cid:173)
`
`density lipoprotein (VLDL) cholesterol by 24.4% (p < 0.0001 ), lipoprotein-associated
`
`phospholipase A2 ("Lp-PLA2") by 19.0% (p < 0.0001 ), and high-sensitivity C-reactive
`
`protein ("hsCRP") by 22.0%. Applicants respectfully submit that the statistically
`
`significant reduction in LDL-C levels compared to placebo control with 4 g per day of
`
`AMR-101 in the ANCHOR trial was unexpected and is of significant clinical importance.
`
`By contrast, Davidson administered Omacor® or placebo to subjects on stable
`
`statin therapy. Davidson's Omacor® group experienced a median increase in LDL-C of
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`3.5% (mean increase of 5.3%; p = 0.052) compared to control (statin + placebo). As
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`discussed above, a similar result was observed in Saito when 1.8 g of Epadel was
`
`administered (instead of Omacor®). Saito observed a relative increase in LDL-C of 2%
`
`for Epadel + statin as compared with statin alone. Saito differed from Davidson in that
`
`Saito's subjects were not on stable statin therapy but rather were given, after a washout
`
`period, E-EPA + statin or statin monotherapy.
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`Saito's control group (statin without E-EPA) showed a 22% mean reduction in
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`LDL-C compared to baseline whereas Saito's active treatment group (statin + E-EPA;
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`referred to by Saito as the "EPA group") showed only a 20% reduction in LDL-C.
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`Application No. 13/768,906
`Reply to Office Action of May 24, 2013
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`Docket No.: 888968004US10
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`Therefore, the addition of E-EPA to a statin in Saito, if anything, produced a less
`
`favorable LDL-C lowering profile than was seen in the statin-only arm. That is, statin
`
`alone reduced LDL-C more than statin plus Epadel.
`
`A summary of the results of Davidson, Saito, and ANCHOR are shown in Table
`
`1, below.
`
`Study
`Comparison
`
`LDL-C Change:
`Active vs. Control
`* Represented as median values, ** represented as mean values
`
`Davidson
`OMACOR®+
`Statin vs. Statin +
`Placebo*
`+ 3.5% (P = 0.052)
`
`Saito
`Epadel + Statin
`vs.
`Statin Alone**
`+2%
`
`ANCHOR
`4 g AMR101 + Statin
`vs. Statin + Placebo*
`
`- 6.2% (P < 0.001)
`
`Because both the OMACOR® + statin therapy in Davidson and the Epadel +
`
`statin therapy in Saito increased LDL-C compared to statin plus placebo or statin alone,
`
`it was, as of the effective filing date, entirely unexpected that the substitution of
`
`Omacor® in Davidson with 4 g per day of ethyl-EPA would have lowered LDL-C
`
`compared to statin + placebo.
`
`Instead, the person skilled in the art reading Davidson,
`
`and Saito would have expected that substituting Omacor® with 4 g of purified E-EPA in
`
`the Davidson paper would produce the same outcome Davidson reported with
`
`Omacor®-namely, no statistically significant change in LDL-C compared to statin +
`
`placebo. In fact, at the outset of the ANCHOR trial, Dr. Paresh Soni expected just that.
`
`At paragraphs 11 - 13 of the Declaration of Dr. Soni dated May 31, 2013 and executed
`
`June 6 2013 ("Soni Declaration"; originally submitted
`
`in co-pending application
`
`13/768,897 in response to the same rejection) attached herewith, Dr. Soni states:
`
`Based at least in part on the COMBOS trial (i.e. Davidson) and
`11.
`Saito which both reported numeric increases in LDL-C in the respective
`treatment groups compared to control, prior to the ANCHOR study I
`expected that the ANCHOR subjects would also exhibit no significant
`change and perhaps even a numeric increase in LDL-C compared to
`placebo control.
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`Application No. 13/768,906
`Reply to Office Action of May 24, 2013
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`Docket No.: 888968004US10
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`Surprisingly, upon administration of 4 g per day AMR101, the
`12.
`subjects in ANCHOR exhibited a median 6% placebo-adjusted reduction
`in LDL-C. The 6% reduction in LDL-C in the ANCHOR study is clinically
`meaningful because 6% represents the expected reduction in LDL-C
`achievable with each doubling of the dose of statin therapy after the initial
`dose (commonly referred to by lipidologists as the "Rule of 6").
`
`Statins are associated with side effects including muscle pain and
`13.
`in some cases rhabdomyolysis (leading to liver damage and kidney
`failure). Due to these side effects, many statin-treated patients in the
`general population are already at their maximally tolerated statin dose.
`Thus, the ability to achieve a reduction in LDL-C equivalent to that
`expected to be achieved by the doubling of a statin dose, without the side
`effects associated with doubling a patient's statin dose, represents a
`significant advance in the field.
`
`Under Federal Circuit precedent, "when an applicant demonstrates substantially
`
`improved results ... and states that the results were unexpected, this should suffice to
`
`establish unexpected results in the absence of evidence to the contrary." In re Soni, 54
`
`F.3d 746, 751 (Fed. Cir. 1995). This principle is particularly relevant to the claimed
`
`invention because the claims recite methods of use of chemical compounds. As the
`
`Federal Circuit remarked, "the basic principle [of what] would have been surprising to a
`
`person of ordinary skills in the particular art would not have been obvious ... applies
`
`most often to the less predictable fields, such as chemistry, where minor changes in a
`
`product or process may yield substantially different results."
`
`Id. Applicants therefore
`
`respectfully request withdrawal of the outstanding rejection.
`
`Furthermore, Applicants also note that there is no requirement that unexpected
`
`results be recited in the claims. The courts have consistently held that there is no
`
`requirement that unexpected properties be specifically recited within a claim even when
`
`rebutting a prima facie case of obviousness based upon unexpected properties. See
`
`Application of Merchant, 575 F.2d 865, 869 (C.C.P.A. 1978) where the Court of
`
`Customs and Patent Appeals (C.C.P.A.) stated "[w]e are aware of no law requiring that
`
`unexpected results relied upon for patentability be recited in the claims." See also,
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`Application of Fenton, 451 F.2d 640, 642 (C.C.P.A. 1971), where the C.C.P.A. stated
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`Application No. 13/768,906
`Reply to Office Action of May 24, 2013
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`Docket No.: 888968004US10
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`that the results obtainable by a claimed process are relevant to the patentability even
`
`though they are not recited within the claims; In re Estes, 420 F.2d 1397, 1399
`
`(C.C.P.A. 1971 ), where the C.C.P.A. reversed the Board's affirmance of an obviousness
`
`rejection when the Board failed to consider evidence of unexpected results because the
`
`unexpected properties were not expressly recited in the claims.
`
`More recently, the Court of Appeals for the Federal Circuit has held that there is
`
`no requirement that unexpected properties of a claimed invention even be recognized
`
`as of filing date of a patent application, never mind be recited within the claims. See,
`
`Knoll Pharm. Co. v. Teva Pharms. USA, Inc., 367 F.3d 1381, 1385 (Fed. Cir. 2004 );
`
`Genetics Institute, LLC v. Novartis Vaccines and Diagnostics, Inc., 655 F .3d 1291, 1307
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`(Fed. Cir. 2011 ).
`
`In view of the foregoing, Applicants respectfully submit that the Office has failed
`
`to establish a prima facie case of obviousness. However, assuming for the sake of
`
`argument only, even if the Office has established a prima facie case of obviousness,
`
`Applicants submit that the prima facie case is overcome by the evidence of unexpected
`
`results presented herein. Accordingly, Applicants request that the rejections be
`
`reconsidered and withdrawn.
`
`Ill.
`
`Rejections Over Rongen In View of Saito.
`
`Claims 1 - 12 and 14 - 19 stand rejected over Rongen (US 2007/0191467) in
`
`view of Saito. Rongen's working example reports the same data reported in Davidson
`
`(COMBOS) wherein subjects on statin therapy treated with Omacor® exhibited an
`
`increase
`
`in LDL-C.
`
`Thus,
`
`for the same reasons discussed above, Applicants
`
`respectfully submit that the Office has failed to establish a prima facie case of
`
`obviousness. However, assuming for the sake of argument only, even if the Office has
`
`established a prima facie case of obviousness, Applicants submit that the prima facie
`
`case has been overcome by the evidence of unexpected results presented herein.
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`Application No. 13/768,906
`Reply to Office Action of May 24, 2013
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`Docket No.: 888968004US10
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`Again, because both the OMACOR® + statin therapy in Davidson/Rongen and
`
`the Epadel + statin therapy in Saito increased LDL-C compared to statin plus placebo or
`
`statin alone, it was, as of the effective filing date, entirely unexpected that the
`
`substitution of Omacor® in Davidson with 4 g per day of ethyl-EPA would have lowered
`
`LDL-C when compared to statin + placebo. Instead, the person skilled in the art reading
`
`Davidson/Rongen and Saito would have expected that substituting Omacor® with 4 g
`
`of purified E-EPA in the Davidson/Rongen example would produce the same outcome
`
`Davidson reported with Omacor®-namely, a 5.2% non-significant increase in LDL-C
`
`compared to statin + placebo.
`
`Double Patenting
`
`Claims 1-19 are provisionally
`
`rejected on
`
`the ground of nonstatutory
`
`obviousness-type double patenting as being unpatentable over claims 1-10, 12-15, 20-
`
`22 and 24-25 of co-pending Application No. 12/815,569 (the '"569 Application") now
`
`U.S. Patent No. 8,455,472.
`
`Claims 1-19 are provisionally
`
`rejected on
`
`the ground of nonstatutory
`
`obviousness-type double patenting as being unpatentable over claims 19-33 of co(cid:173)
`
`pending Application No. 13/124,628 (the "'628 Application").
`
`Claims 1-19 are provisionally
`
`rejected on
`
`the ground of nonstatutory
`
`obviousness-type double patenting as being unpatentable over claims 21-27 of co(cid:173)
`
`pending Application No. 13/266,085 (the "'085 Application").
`
`Claims 1-19 are provisionally
`
`rejected on
`
`the ground of nonstatutory
`
`obviousness-type double patenting as being unpatentable over claims 1-17 of co(cid:173)
`
`pending Application No. 13/359, 114 (the "'114 Application").
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`Application No. 13/768,906
`Reply to Office Action of May 24, 2013
`
`Docket No.: 888968004US10
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`Claims 1-19 are provisionally
`
`rejected on
`
`the ground of nonstatutory
`
`obviousness-type double patenting as being unpatentable over claims 1, 5-17 and 21 of
`
`co-pending Application No. 13/403,699 (the '"699 Application").
`
`Claims 1-19 are provisionally
`
`rejected on
`
`the ground of nonstatutory
`
`obviousness-type double patenting as being unpatentable over claims 1-15 of co(cid:173)
`
`pending Application No. 13/404,686 (the "'686 Application").
`
`Claims 1-19 are provisionally
`
`rejected on
`
`the ground of nonstatutory
`
`obviousness-type double patenting as being unpatentable over claims 8-17 and 22-24
`
`of co-pending Application No. 13/540,319 (the "'319 Application").
`
`Claims 1-19 are provisionally
`
`rejected on
`
`the ground of nonstatutory
`
`obviousness-type double patenting as being unpatentable over claims 31-32 and 34-38
`
`of co-pending Application No. 13/614,111 (the "'111 Application"), now U.S. Patent
`
`8,454,994.
`
`Claims 1-19 are provisionally
`
`rejected on
`
`the ground of nonstatutory
`
`obviousness-type double patenting as being unpatentable over claims 1-21 of co(cid:173)
`
`pending Application No. 13/768,897 (the "'897 Application").
`
`Claims 1-19 are provisionally
`
`rejected on
`
`the ground of nonstatutory
`
`obviousness-type double patenting as being unpatentable over claims 1-19 of co(cid:173)
`
`pending Application No. 13/768,869 (the "'869 Application").
`
`Claims 1-19 are provisionally
`
`rejected on
`
`the ground of nonstatutory
`
`obviousness-type double patenting as being unpatentable over claims 1-13 of U.S.
`
`Patent No. 8,410,086 (the "'086 Patent").
`
`LEGAL26918830.l
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`13
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`Hikma Pharmaceuticals
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`IPR2022-00215
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`Ex. 1025, p. 13 of 16
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`

`

`Application No. 13/768,906
`Reply to Office Action of May 24, 2013
`
`Docket No.: 888968004US10
`
`The Applicant accordingly does not concede to the merits of these rejections.
`
`Nonetheless, in the interest of expediting prosecution of the present application,
`
`terminal disclaimers have been filed for the above-listed patents and applications.
`
`LEGAL26918830.l
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`14
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`Hikma Pharmaceuticals
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`IPR2022-00215
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`Ex. 1025, p. 14 of 16
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`

`

`Application No. 13/768,906
`Reply to Office Action of May 24, 2013
`
`No Disclaimers or Disavowals
`
`Docket No.: 888968004US10
`
`Although the present communication may include alterations to the application or
`
`claims, or characterizations of claim scope or referenced art, Applicant is not conceding
`
`in this application that previously pending claims are not patentable over the cited
`
`references. Rather, any alterations or characterizations are being made to facilitate
`
`expeditious prosecution of this application. Applicant reserves the right to pursue at a
`
`later date any previously pending or other broader or narrower claims that capture any
`
`subject matter supported by the present disclosure, including subject matter found to be
`
`specifically disclaimed herein or by any prior prosecution. Accordingly, reviewers of this
`
`or any parent, child or related prosecution history shall not reasonably infer that
`
`Applicant has made any disclaimers or disavowals of any subject matter supported by
`
`the present application.
`
`LEGAL26918830.l
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`15
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`Hikma Pharmaceuticals
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`IPR2022-00215
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`Ex. 1025, p. 15 of 16
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`

`

`Application No. 13/768,906
`Reply to Office Action of May 24, 2013
`
`Docket No.: 888968004US10
`
`CONCLUSION
`
`In view of the above amendment, applicant believes the pending application is in
`
`condition for allowance.
`
`If the Examiner believes that a conference would be of value in expediting the
`
`prosecution of this application, he is cordially invited to telephone the undersigned
`
`counsel at (312) 324-8400 to arrange for such a conference.
`
`Applicant believes no fee is due with this response. However, if a fee is due,
`
`please charge our Deposit Account No. 50-0665, under Order No. 888968004US10
`
`from which the undersigned is authorized to draw.
`
`Dated: -----"A"""'"u'""'"g'"""u"""st-'--'2"'""'6'-'"-1 -=2..a;..0 1-'-'3"----_
`
`Respectfully submitted,
`
`By_/davidbfourn ier/ __
`David B. Fournier
`Registration No.: 51,696
`PERKINS COIE LLP
`131 South Dearborn Street
`Chicago, Illinois 60603
`(312) 324-8400
`(312) 324-9400 (Fax)
`Attorney for Applicant
`
`LEGAL26918830.l
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`16
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`Hikma Pharmaceuticals
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`IPR2022-00215
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`Ex. 1025, p. 16 of 16
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`