ATTORNEY DOCKET NO. 244168.000007.US.9
`PATENT
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Application of:
`
`Giorgio CALDERARI et al.
`
`Application No.: 13/901,830
`
`Filed: May 24,2013
`
`For:
`
`LIQUID PHARMACEUTICAL
`FORMULATIONS OF
`PALONOSETRON
`
`)
`)
`) Group Art Unit: 1628
`)
`
`) Examiner: Shirley V. GEMBEH
`)
`)
`) Confirmation No.: 3806
`)
`)
`
`SUPPLEMENTAL AMENDMENT AND RESPONSE TO OFFICE ACTION
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Dear Sir:
`
`TROUTMAN SANDERS
`Customer Number 06980
`
`In further response to the Office Action mailed November 22, 2013, please enter the
`following amendments and consider the following remarks.
`A REPLACEMENT CLAIM SET begins on page 2.
`REMARKS begin on page 4.
`
`24880533v1
`
`._________JI I
`
`Dr. Reddy’s Laboratories, Ltd., et al.
`v.
`Helsinn Healthcare S.A., et al.
`U.S. Patent No. 9,(cid:20)(cid:26)(cid:22),(cid:28)(cid:23)(cid:21)
`Reddy Exhibit 1024
`
`Exh. 1024
`
`

`
`U.S. Application No. 13/901,830
`Supplemental Reply to Office Action
`March 3, 2015
`Page 2 of 13
`
`REPLACEMENT CLAIM SET
`
`(Canceled)
`1-25.
`(New) A formulation comprising a pharmaceutical sterile aqueous intravenous
`26.
`solution, wherein said pharmaceutical sterile aqueous intravenous solution comprises:
`palonosetron hydrochloride or another pharmaceutically acceptable salt of palonosetron
`at a concentration of0.05 mg/mL based on the weight of the palonosetron free base; and
`from about 10 mg/mL to about 80 mg/mL mannitol;
`wherein the pharmaceutical sterile aqueous intravenous solution has a pH of 4.0 to 6.0.
`27.
`(New) The formulation of claim 26, wherein said pharmaceutical sterile aqueous
`intravenous solution comprises palonosetron hydrochloride or another pharmaceutically
`acceptable salt of palonosetron is in an amount of 0.25 mg.
`28.
`(New) The formulation of claim 26, wherein said pharmaceutical sterile aqueous
`intravenous solution comprises from about 20 mg/mL to about 60 mg/mL mannitol.
`29.
`(New) The formulation of claim 26, wherein said pharmaceutical sterile aqueous
`intravenous solution comprises from about 40 mg/mL to about 45 mg/mL mannitol.
`(New) The formulation of claim 26, wherein said pharmaceutical sterile aqueous
`30.
`intravenous solution comprises 41.5 mg/mL mannitol.
`31.
`(New) The formulation of claim 26, wherein said pharmaceutical sterile aqueous
`intravenous solution comprises a chelating agent.
`(New) The formulation of claim 31, wherein said chelating agent is EDT A.
`32.
`33.
`(New) The formulation of claim 32, wherein said pharmaceutical sterile aqueous
`intravenous solution comprises from about 0.3 mg/mL to about 0.7 mg/mL EDT A.
`34.
`(New) The formulation of claim 32, wherein said pharmaceutical sterile aqueous
`intravenous solution comprises 0.5 mg/mL EDT A.
`35.
`(New) The formulation of claim 26, wherein said pharmaceutical sterile aqueous
`intravenous solution has a pH of 5.0 ± 0.5.
`36.
`(New) The formulation of claim 26, wherein said pharmaceutical sterile aqueous
`intravenous solution comprises a citrate buffer.
`
`24880533v1
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`Exh. 1024
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`

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`U.S. Application No. 13/901,830
`Supplemental Reply to Office Action
`March 3, 2015
`Page 3 of 13
`
`(New) A formulation comprising a pharmaceutical sterile aqueous intravenous
`37.
`solution, wherein said pharmaceutical sterile aqueous intravenous solution comprises:
`palonosetron hydrochloride or another pharmaceutically acceptable salt of palonosetron
`at a concentration of0.05 mg/mL based on the weight of the palonosetron free base;
`from about 10 mg/mL to about 80 mg/mL mannitol; and
`from about 0.3 mg/mL to about 0.7 mg/mL EDT A.
`38.
`(New) The formulation of claim 37, wherein said pharmaceutical sterile aqueous
`intravenous solution comprises palonosetron hydrochloride or another pharmaceutically
`acceptable salt of palonosetron is in an amount of 0.25 mg.
`39.
`(New) The formulation of claim 37, wherein said pharmaceutical sterile aqueous
`intravenous solution has a pH of 4.0 to 6.0.
`40.
`(New) The formulation of claim 37, wherein said pharmaceutical sterile aqueous
`intravenous solution has a pH of 5.0 ± 0.5.
`41.
`(New) The formulation of claim 37, wherein said pharmaceutical sterile aqueous
`intravenous solution comprises from about 20 mg/mL to about 60 mg/mL mannitol.
`(New) The formulation of claim 37, wherein said pharmaceutical sterile aqueous
`42.
`intravenous solution comprises from about 40 mg/mL to about 45 mg/mL mannitol.
`(New) The formulation of claim 37, wherein said pharmaceutical sterile aqueous
`43.
`intravenous solution comprises 41.5 mg/mL mannitol and 0.5 mg/mL EDT A.
`44.
`(New) The formulation of claim 37, wherein said pharmaceutical sterile aqueous
`intravenous solution comprises a citrate buffer.
`
`24880533v1
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`Exh. 1024
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`

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`U.S. Application No. 13/901,830
`Supplemental Reply to Office Action
`March 3, 2015
`Page 4 of 13
`
`Status of Claims
`
`REMARKS
`
`Upon entry of this Supplemental Amendment, claims 26-44 will be pending in this
`application. Claims 1-9 were previously canceled and claims 10-25 are canceled herein, all
`without prejudice or disclaimer. New claims 26-44 are added by this amendment. Support for
`the new claims can be found throughout the specification of the priority application (U.S.
`Provisional Application No. 60/444,351 ), for instance at:
`- page 2, lines 4-6;
`-page 5, line 3 to page 6, line 2;
`- page 6, line 16 to page 7, line 1;
`-page 7, line 29 to page 8, line 8;
`-page 8 lines 14-25;
`-page 8, line 26 to page 9, line 23;
`-page 10, lines 9-25; and
`-Examples 1-3.
`No new matter is added by this amendment.
`
`Status o(Application
`
`On February 21, 2014, Applicants filed a timely and complete response to the Office
`Action mailed November 22, 2013. On April 17, 2014, Applicants requested a three-month
`suspension of prosecution to consider the strategic direction of this application relative to
`Applicants' other pending applications. On August 25, 2014, Applicants requested an additional
`three-month suspension to continue such consideration. Applicants hereby request that
`prosecution of this application be resumed and examination extended to include new claims 26-
`44 presented herein.
`The remarks presented in the Response filed February 21, 2014, regarding the
`patentability of claims 10-18 remain in full force and are incorporated herein by reference. In the
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`24880533v1
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`

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`U.S. Application No. 13/901,830
`Supplemental Reply to Office Action
`March 3, 2015
`Page 5 of 13
`
`pages that follow, Applicants provide reasons why the previous obviousness rejection of claims
`10-18 does not apply to new claims 26-44.
`
`Rejection Under 35 US. C. § 103
`
`In the Office Action mailed November 22, 2103, the Office rejected claims 10-18 under
`pre-AIA1 35 U.S.C. § 103 as obvious over U.S. Patent No. 5,202,333 to Berger et al. ("Berger")
`in view of Barton "Citric Buffer Calculation" (2000) ("Barton") and U.S. Patent No. 6,284,749
`to Castillo et al. ("Castillo"), and further in view of U.S. Patent No. 5,854,270 to Gambhir
`("Gambhir") as evidenced by Matsumoto et al. "Manual for Practical Pharmacy" (1989)
`("Matsumoto"). Office Action at pp. 3-8. For the reasons discussed below, Applicants
`respectfully traverse this rejection with respect to new claims 26-44.
`
`A.
`
`The Concentration of Palonosetron Hydrochloride Recited m Claims 26-44
`Would Not Have Been Obvious
`
`Applicants have prosecuted several applications in the same family as this application,
`including U.S. Patent No. 8,598,219 ("the '219 patent"), which is the parent of this application.
`Like the claims of the '219 patent, claims 26-44 recite a specific concentration of palonosetron
`hydrochloride of 0.05 mg/mL based on the weight of its free base. The Office has already
`acknowledged that Berger is directed toward much higher concentrations of 10 to 100 mg/mL
`and thus, would have led the POSIT A away from using the claimed concentration in intravenous
`formulations. See Interview Summary dated October 11, 2013 in the '219 file history.
`Specifically, the Office stated, in distinguishing the 0.05 mg/mL (i.e., 0.25 mg/5 mL)
`palonosetron hydrochloride concentration recited in the '219 claims, that Berger describes "high
`concentrations." The Office supported that conclusion by referencing Berger's Example 13,
`
`As discussed in the Response filed February 21, 2014, Applicants believe that this case
`should be examined under post-AlA 35 U.S.C. § 103 because it claims priority to an application
`that presented a claim having a priority date after March 16, 2013. See also the "Choice of Law"
`section of the Preliminary Amendment filed May 24, 2013. Nevertheless, Applicants do not
`believe that the choice of law has any bearing on the patentability of the claims.
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`24880533v1
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`

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`U.S. Application No. 13/901,830
`Supplemental Reply to Office Action
`March 3, 2015
`Page 6 of 13
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`which describes concentrations (10 to 100 mg/mL) that are approximately 200-2,000 times
`higher2 than the currently claimed concentrations:
`
`This is commensurate with the low concentration described in the
`the high concentrations
`claims (0.25 mg/5 mL) relative to
`described in the prior art (Berger 5,202,333, Example 13).
`
`!d.
`
`As Applicant argued, and the Office agreed, nothing in Berger suggests moving from
`Berger's broad range of concentrations to the low claimed concentration, especially when the
`high concentrations exemplified in Example 13 are considered. In fact, the high concentrations in
`Berger's examples (i.e., 10 mg/mL and 100 mg/mL), would have moved the POSIT A away from
`the lower claimed concentration. Thus, claims 26-44, which recite the same concentration of
`palonosetron hydrochloride as the concentration claimed in the '219 patent, are allowable for at
`least the same reasons as the claims of the '219 patent.
`Nevertheless, Applicants submit the following additional arguments to explain why the
`subject matter of claims 26-44 would not have been obvious in view of the Office's cited
`references when the claimed invention was made.
`
`B.
`
`The POSITA Would Not Have Arrived at the Claimed Concentration VIa
`''Routine Experimentation/Optimization''
`
`The Office has concluded that the primary reference, Berger, would have rendered the
`claims obvious, inter alia, because it teaches "the concentration of palonosetron is from
`0.000001% w to 10% weight" and, "optimization of the concentration is within the purview of
`one of ordinary skill in the art." !d. at pp. 10, 12.
`Applicants respectfully disagree and submit that "routine experimentation/ optimization"
`does not support a rejection of claims 26-44. The POSITA would have found nothing routine
`about going from Berger's enormously broad concentration ranges to the specific concentration
`
`2
`10 mg/mL, the lowest of Berger's exemplified concentrations and is 200 times higher
`than the claimed concentration of0.05 mg/mL. 100 mg/mL, the highest of Berger's exemplified
`concentrations, is 2,000 times higher than the claimed concentration of0.05 mg/mL.
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`24880533v1
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`

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`U.S. Application No. 13/901,830
`Supplemental Reply to Office Action
`March 3, 2015
`Page 7 of 13
`
`recited in claims 26-44. Such a modification would have required a vast amount of work, with no
`reasonable expectation of success and no direction leading to the claimed values.
`Berger describes a "general" concentration range spanning seven orders of magnitude
`(i.e., "from 0.000001% w to 10.0% w"; col. 12, 11. 64-65; see also Office Action at p. 10), and
`subsequently leads the POSIT A to a preferred concentration range that spans five orders of
`magnitude (i.e., "preferably 0.00001% w to 1.0% w"; col. 12, 11. 66-67), and eventually to a
`concentration range of 1 0-100 mg/mL in Example 13.
`Thus, Berger's teachings would have led the POSIT A along the following path:
`
`(1) "In general, the final composition will comprise from
`0.000001% w to 10% w" (col. 12, 11. 64-65).
`
`(2) "preferably 0.00001% w to 1.0% w" (col. 12, 11. 66-67).
`
`!
`!
`
`(3) only exemplified composition for intravenous administration
`(Example 13): 1% w to 10% w concentrations.
`
`It would have taken a prodigious amount of work by the POSIT A, with no reasonable
`expectation of success and no direction (i.e., no sign posts or trail markers), to go from the wide
`concentration ranges disclosed by Berger to the specific concentration described in claims 26-44.
`This is especially true when Berger's only exemplified intravenous concentration range in
`Example 13 (10-100 mg/mL) is 200-2,000 times greater than the claimed concentration (see
`above). Thus, to the extent that Berger gave the POSIT A any direction whatsoever, it was
`direction, such as the range in Example 13, that would have led the POSITA away from the
`claimed invention.
`Because of the large amount of work needed for the POSIT A to go from Berger's broad
`concentration disclosures, and because there was absolutely no guidance in Berger leading to the
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`U.S. Application No. 13/901,830
`Supplemental Reply to Office Action
`March 3, 2015
`Page 8 of 13
`
`claimed concentration, it would have taken far more than "routine experimentation" for the
`POSIT A to arrive at the invention of claims 26-44.
`The doctrine of "routine experimentation" cannot be applied to claims 26-44 for
`additional reasons. In particular, the concept of "routine experimentation" can be found in the
`Office's KSR Examination Guidelines in its "obvious to try" discussion, which makes clear that
`the doctrine is limited. As stated in the Examination Guidelines Update: Developments in the
`Obviousness Inquiry After KSR v. Teleflex, published at 75 Fed. Reg. 53643, at 53654
`("Guidelines"):
`
`This rationale is only appropriate when there is a recognized
`problem or need in the art; there are a finite number of identified,
`predictable solutions to the recognized need or problem; and one of
`ordinary skill in the art could have pursued these known potential
`solutions with a reasonable expectation of success.
`
`As this discussion makes clear, the "obvious to try" rationale is only appropriate when
`there are a finite number of predictable solutions. Berger's broad concentration ranges spanning
`five and seven orders of magnitude are, for practical purposes, anything but a finite number of
`predictable solutions made available to the POSITA. See Office Guidelines at 53655, 53660
`(citing Ortho-McNeil Pharm., Inc. v. Mylan Labs, Inc. 520 F.3d 1358 (Fed. Cir. 2008), which
`notes that "several" unpredictable alternatives is not a "finite number of identified, predictable
`solutions," and "several" is certainly far less than 104
`, 105
`, 106
`, and 10\
`Of Ortho-McNeil, MPEP 2143, E, Example 5 states that "finite" means "small or easily
`traversed":
`
`The Federal Circuit affirmed. The Federal Circuit pointed out
`that ... there would have been no reason to test that intermediate
`for anticonvulsant properties if treating diabetes had been the
`goal. ... Summarizing their conclusion with regard to Mylan's
`obvious to try argument, the Federal Circuit stated:
`
`[T]his invention, contrary to Mylan's characterization, does
`not present a finite (and small in the context of the art)
`number of options easily traversed to show obviousness ...
`. KSR posits a situation with a finite, and in the context of
`the art, small or easily traversed, number of options that
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`U.S. Application No. 13/901,830
`Supplemental Reply to Office Action
`March 3, 2015
`Page 9 of 13
`
`artisan of
`skilled
`an ordinarily
`convince
`would
`obviousness .... [T]his clearly is not the easily traversed,
`small and finite number of alternatives that KSR suggested
`might support an inference of obviousness. !d. at 1364, 86
`USPQ2d at 1201.
`
`to clarify the Supreme Court's
`Thus, Ortho-McNeil helps
`requirement in KSR for "a finite number" of predictable solutions
`when an obvious to try rationale is applied: under the Federal
`Circuit's case law "finite" means "small or easill traversed" in the
`context of the art in question. (Emphasis added.)
`
`The MPEP further elaborates on the "obvious to try" doctrine, and gives two classes of
`situations in section 2143 in which it is improper to apply an "obvious to try" rationale.
`According to MPEP 2143 IE (Example 3), the Office should not use an obvious to try rationale
`to reject an application:
`
`(1) when what would have been "obvious to try" would have been
`to vary all parameters or try each of numerous possible choices
`until one possibly arrived at a successful result, where the prior art
`gave either no indication of which parameters were critical or no
`direction as to which of many possible choices is likely to be
`successful; and
`
`(2) when what was "obvious to try" was to explore a new
`technology or general approach that seemed to be a promising field
`of experimentation, where the prior art gave only general guidance
`as to the particular form of the claimed invention or how to achieve
`it.
`
`3
`In the Patent Trial & Appeal Board's ("Board") decision in International Flavors &
`Fragrances Inc. v. USA., IPR2013-00124, Paper 12, at 15 (P.T.A.B. May 20, 2014), the Board
`relied on Ortho McNeil's characterization of "finite" as "small or easily traversed" when finding
`that patentee's amended claims directed to modified insect repellant compounds would have
`been nonobvious. After considering evidence of what the POSIT A would have understood, the
`Board stated that the prior art failed to provide any reason to modify the known insect repellant
`to arrive at the modified compounds or a reasonable expectation that such modifications would
`result in a compound with the desired insect repellent activity. !d. at 16. Berger and its enormous
`concentration ranges also do nothing to point the POSITA towards the presently claimed
`concentration.
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`U.S. Application No. 13/901,830
`Supplemental Reply to Office Action
`March 3, 2015
`Page 10 of 13
`
`Both of those situations apply here. Berger, as noted, provides a "general" range of
`concentrations that spans seven orders of magnitude (i.e., 0. 000001% w to 10.0% w ), involving
`at least 10 7 choices. To be sure, Berger narrows the broad concentration range to encompass five
`orders of magnitude (i.e. "preferably 0.00001% w to 1.0% w"), involving at least 105 choices.
`But even that narrowed range remains very broad and to arrive at the presently claimed
`concentration based on these general teachings in Berger, the POSIT A would have had to try a
`practically infinite number of possible choices of concentrations. And the POSIT A would have
`faced that practically impossible task with absolutely nothing pointing her towards the presently
`claimed concentration. Berger's general guidance providing a range of 105 or 107 concentrations
`would have been no reasonable guidance at all.
`To be sure, Berger also exemplifies a single representative intravenous formulation, itself
`having a range of concentrations of active ingredients spanning 1% w to 10% w (i.e.,
`"10-100 mg" in "1 mL"), involving fewer choices than the general concentration ranges
`discussed above. See Example 13, col. 29, 11. 1-13. But that example of Berger moves in an
`opposite direction within Berger's broad concentration ranges compared to the much LOWER
`claimed concentration of 0.05 mg/mL.
`These differences between Berger's disclosure and the claimed invention are significant.
`As is well established, "[ e ]vidence that others were 'going in different ways' is strong evidence
`that the [inventor's] way would not have been obvious." In re Cyclobenzaprine Hydrochloride
`Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1082 (Fed. Cir. 2012) (citing Panduit
`Corp. v. Dennison Mfg. Co., 774 F.2d 1082, 1099 (Fed. Cir. 1985), which MPEP §§ 2144.08,
`1504.03, and 2141.02, all cite with approval for other reasons).
`There is no rationale of record that would have motivated the POSITA to decrease
`Berger's exemplified range of high concentrations for intravenous formulations and thereby
`obtain the presently claimed concentration. Rather, Berger would have led the POSITA away
`from the presently claimed value.
`And, of course, the fact that the claimed concentration (i.e., a species) is encompassed by
`Berger's broad genera of 105 and 10 7 concentrations is not sufficient by itself to establish a prima
`facie case of obviousness. The Office must establish that the POSITA would have been
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`24880533v1
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`Exh. 1024
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`

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`U.S. Application No. 13/901,830
`Supplemental Reply to Office Action
`March 3, 2015
`Page 11 of 13
`
`motivated to select the claimed concentration from Berger's broad disclosure. See MPEP
`§ 2144.08 II A (4) (a)-(f).
`The secondary references cited by the Office fail to provide such a motivation. None of
`those references even deals with palonosetron hydrochloride, much less would have indicated to
`the worker of ordinary skill any direction within Berger's broad concentration ranges that span
`105 and 107 orders of magnitude.
`For all these reasons, Applicants respectfully submit that the Office Action lacks a prima
`facie case of obviousness with respect to claims 26-44.
`
`C.
`
`Applicants Rebut Any Prima Facie Case of Obviousness That Might Have Been
`Established
`
`Even assuming, arguendo, that the Office Action had set forth a prima facie case of
`obviousness, which Applicants respectfully submit it did not, Applicants have rebutted any such
`alleged prima facie case. Rebuttal evidence may include evidence that the claimed invention
`yields unexpectedly improved properties or properties not present in the prior art. M.P.E.P.
`§ 2145.
`"Whether the unexpected results are the result of unexpectedly improved results or a
`property not taught by the prior art, the 'objective evidence of non-obviousness must be
`commensurate in scope with the claims which the evidence is offered to support."' !d. at
`§ 716.02(d) (citing In re Clemens, 622 F.2d 1029, 1036 (C.C.P.A. 1980)). However, "[w]hen
`considering whether proffered evidence is commensurate in scope with the claimed invention,
`Office personnel should not require the applicant to show unexpected results over the entire
`range of properties possessed by a chemical compound or composition. Evidence that the
`compound or composition possesses superior and unexpected properties in one of a spectrum of
`common properties can be sufficient to rebut a prima facie case of obviousness. "!d. at § 2145
`(internal citations omitted).
`Here, Applicants unexpectedly discovered that as the concentration of palonosetron
`hydrochloride in a pharmaceutical formulation decreases, the stability of the formulation
`increases. For example as discussed in Example 2, a formulation optimization study was
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`U.S. Application No. 13/901,830
`Supplemental Reply to Office Action
`March 3, 2015
`Page 12 of 13
`
`performed using experimental design software. Twenty-four lots of drug product were analyzed
`to investigate, inter alia, the appropriate concentration ranges for palonosetron hydrochloride.
`The results of that study indicated that palonosetron hydrochloride concentration was a
`critical factor in chemical stability, "with greatest stability seen at the lowest palonosetron
`hydrochloride concentrations." See Example 2.
`A visual representation of that discovery is depicted in the following graph, which is
`adapted from a Figure of the Bonadeo Declaration dated February 9, 2009 (of record):
`
`.,~
`.. ]
`!~(l~.I<DAlK~~ 2 ·1
`
`~Al!::J;:o:)N~lt,.N'l , ~
`
`~-~
`
`As can be seen from this Figure, Applicants unexpectedly discovered that as the
`concentration of palonosetron hydrochloride decreases from 5 mg/mL toward the presently
`claimed low concentration of 0.05 mg/mL, the palonosetron degradation rate decreases (follow
`the line on the right-hand side of the figure from back to front). See also Supplemental Bonadeo
`Declaration (of record) at Exhibit 3 (demonstrating reduced chemical stability of palonosetron
`hydrochloride at 10 mg/mL and 50 mg/mL, which are the lower end and middle of Berger's
`Example 13 range of concentrations).
`This stability of formulations compnsmg different concentrations of palonosetron
`hydrochloride would have been unpredictable. See, e.g., Stella Declaration dated September 19,
`2007 (of record). Indeed, Berger provided no reason to expect improved stability by lowering the
`palonosetron hydrochloride concentration. Thus, the unexpected stability of compositions
`comprising palonosetron hydrochloride at the presently claimed concentration could not have
`been reasonably predicted based on Berger's teachings.
`For all these reasons, Applicants respectfully submit that claims 26-44 would not have
`been obvious over the Office's cited combination of references.
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`Exh. 1024
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`U.S. Application No. 13/901,830
`Supplemental Reply to Office Action
`March 3, 2015
`Page 13 of 13
`
`CONCLUSION
`
`In view of the foregoing remarks, Applicants respectfully request reconsideration of this
`application and the timely allowance of the pending claims. Should the Examiner disagree or
`have any questions regarding this submission, the Applicants invite the Examiner to call the
`undersigned at 212.704.6105.
`
`Respectfully submitted,
`
`By:/Clark G. Sullivan/
`Clark G. Sullivan
`Reg. No. 36,942
`
`Troutman Sanders LLP
`Chrysler Bldg, 405 Lexington Ave
`New York, NY 10174
`Phone: (212) 704-6000
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