`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`_____________________________
`
`MYLAN PHARMACEUTICALS INC.,
`WOCKHARDT BIO AG, TEVA PHARMACEUTICALS USA, INC.,
`AUROBINDO PHARMA U.S.A. INC., and SUN PHARMACEUTICAL
`INDUSTRIES, LTD., SUN PHARMA GLOBAL FZE and
`AMNEAL PHARMACEUTICALS LLC,
`Petitioner,
`
`v.
`
`ASTRAZENECA AB,
`Patent Owner.
`
`_____________________________
`
`IPR2015-01340
`Patent RE44,1861
`_____________________________
`
`
`
`PETITIONERS’ RESPONSE TO MOTION FOR OBSERVATIONS
`
`REGARDING THE CROSS-EXAMINATION OF DEFOREST MCDUFF
`
`
`
`1 Petitioner Wockhardt from IPR2016-01209, Petitioner Teva from IPR2016-
`
`01122, Petitioner Aurobindo from IPR2016-01117, and Petitioner Sun/Amneal
`
`from IPR2016-01104 have each been joined as Petitioner to this proceeding.
`
`
`
`Petitioners file this Response to Patent Owner’s Motion for Observations on
`
`Cross-examination of DeForest McDuff (Paper 61) in accordance with Due Date 5
`
`(Papers 17, 35, 57).
`
`Observation #1:
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`Patent Owner complains that Dr. McDuff did not review the entirety of the
`
`district court record, but Patent Owner did not produce the entirety of the district
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`court record in this IPR proceeding. On October 13, 2016, Patent Owner and
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`Petitioner entered a stipulation agreeing that “Petitioner Mylan will rely on the
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`transcript of Dr. Christine Meyer’s September 21, 2016 cross-examination
`
`testimony from District Court Case …and the documents referenced therein” in
`
`lieu of deposing Dr. Meyer in the IPR regarding her declarations. Paper 35, ¶4.
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`The parties also stipulated regarding the scope of district court materials for
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`submission: “The entirety of the District Court Meyer cross-examination…and any
`
`documents referenced therein….” Paper 35, ¶5. Contrary to Patent Owner’s
`
`suggestion in Observation #1, Patent Owner did not produce in this IPR “the
`
`entirety of the record generated in the parallel district court proceeding involving
`
`the RE’186 patent on the issue of commercial success.” In EX2220 at 9:5-7, 14-
`
`19, Dr. McDuff testified that he reviewed all pertinent information in reaching his
`
`conclusions to the extent the information was available. Specifically, Dr. McDuff
`
`testified that he reviewed the Meyer declaration (EX2059A) and the underlying
`
`-1-
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`
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`sources cited in the Meyer declaration and that he was provided with “all or nearly
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`all of the exhibits” put forth by the patent holder. EX2220 at 11:8-12:10. Dr.
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`McDuff also testified that he “reviewed a wide range of academic literature
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`relating to pharmaceuticals” and information “generally about the subject matter of
`
`the case.” EX2220 at 12:11-22. Dr. McDuff testified that he “gathered
`
`information to the extent [he] thought it was relevant” and that “if [he] asked for
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`information from counsel and they had access to that information, [he] was
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`provided that as well.” EX2220 at 15:1-12. Dr. McDuff also testified at 16:4-7
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`that he did not restrict his review to material favorable to Petitioners. Dr. McDuff
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`testified that he was not aware of Patent Owner producing Dr. Meyer’s expert
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`report from the district court proceeding (EX2220 at 17:4-7, 19:9-16), and no such
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`report appears on Patent Owner’s Exhibit List (Paper 64). Dr. McDuff also
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`testified that he understood that Dr. Meyer’s IPR declaration provides the totality
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`of “her opinions here” in the IPR proceeding. EX2220 at 17:19-18:2, 19:9-16,
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`20:4-14. Dr. McDuff testified that he reviewed the Hofmann expert report that was
`
`deemed produced in this IPR by Patent Owner pursuant to the parties' stipulation
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`(Paper 35) “to obtain information that was not available elsewhere.” EX2220 at
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`19:17-22. Dr. McDuff also testified that he reviewed Patent Owner’s cross-
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`examination of Mr. Hofmann’s testimony from the trial in the district court
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`litigation (EX2220 at 18:20-23) and Dr. Meyer’s trial demonstratives (EX2220 at
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`-2-
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`
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`20:15-20), thereby ensuring that he was aware of any deficiencies in Mr.
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`Hofmann’s testimony that Patent Owner had purported to identify. Dr. McDuff
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`testified that he would have liked to review information that AstraZeneca failed to
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`provide in this case, such as information about “discounts and information on early
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`prescriptions and sales in the market.” EX2220 at 14:13-25. Dr. McDuff testified
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`that he was “surprised to see in Dr. Meyer’s declaration given that she makes a
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`claim on pricing that she did not provide information on discounts for Onglyza or
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`Kombiglyze, nor did she provide information for other DPP-4 competitors, nor did
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`AstraZeneca provide any business documents to my knowledge that provide such
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`price comparison.” EX2220 at 139:7-14.
`
`Observation #2:
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`As explained above in Petitioners’ response to Observation #1, Patent
`
`Owner complains that Dr. McDuff did not review the entirety of the district court
`
`record, but Patent Owner did not produce the entirety of the district court record in
`
`this IPR proceeding. The parties stipulated regarding the scope of district court
`
`materials for submission and to the use of Dr. Meyer’s cross-examination in lieu of
`
`a separate deposition in the IPR. Paper 35, ¶¶45. Moreover, Dr. McDuff testified
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`at length regarding the information he reviewed in reaching his conclusions,
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`including the totality of Dr. Meyer’s opinions in this case and the supporting
`
`materials thereto. EX2220 at 9:5-7, 9:14-19, 11:8-12:10, 12:11-22, 15:1-12,16:4-
`
`-3-
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`
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`7. Dr. McDuff testified that he was not aware of Patent Owner producing Dr.
`
`Meyer’s expert report from the district court proceeding (EX2220 at 17:4-7, 19:9-
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`16), and no such report appears on Patent Owner’s Exhibit List (Paper 64). Dr.
`
`McDuff also testified that he understood that Dr. Meyer’s IPR declaration provides
`
`the totality of “her opinions here” in the IPR proceeding. EX2220 at 17:19-18:2,
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`19:9-16, 20:4-14. Dr. McDuff testified that he reviewed the Hofmann expert
`
`report that was deemed produced in this IPR by Patent Owner pursuant to the
`
`parties' stipulation (Paper 35) “to obtain information that was not available
`
`elsewhere.” EX2220 at 19:17-22. Dr. McDuff also testified that he reviewed
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`Patent Owner’s cross-examination of Mr. Hofmann’s testimony from the trial in
`
`the district court litigation (EX2220 at 18:20-23) and Dr. Meyer’s trial
`
`demonstratives (EX2220 at 20:15-20), thereby ensuring that he was aware of any
`
`deficiencies in Mr. Hofmann’s testimony that Patent Owner had purported to
`
`identify.
`
`Observation #3:
`
`In EX2220 at 53:3-54:7, Dr. McDuff testified, that “[t]here are situations
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`where I do have a finding or opinion of commercial success,” and that “I have had
`
`that finding in my work,” but simply that in none of these cases has he served as
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`the testifying expert where the case proceeded to a point where he testified
`
`regarding that opinion. In EX2220 at 159:23:160:11, Dr. McDuff testified that
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`-4-
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`
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`there were “situations where I worked on those cases…[and] I agreed with those
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`opinions that were provided, at least with respect to commercial success of those
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`products.”
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`Observation #4:
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`In EX2220 at 161:22-162:3, Dr. McDuff testified that he has “presented on
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`commercial success as testimony in court” but that “the speaking engagements that
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`I’ve referenced and listed under speaking engagements on my CV” have not been
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`specific to commercial success.”
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`Observation #5:
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`In his declaration, Dr. McDuff stated that “Commercial success is a
`
`secondary consideration that a patent owner may use to argue that a patent is not
`
`obvious based on the alleged commercial success of a product embodying the
`
`invention of the patent. EX1060, ¶13. In EX2220 at 160:12-25 Dr. McDuff
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`testified that he performed an independent analysis in which he focused on
`
`reviewing and discussing the declaration of Dr. Meyer and responding to that
`
`declaration and the claims made there. Dr. McDuff referenced the Patent Owner’s
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`burden of production with regard to commercial success, and stated that he
`
`understood “that the board will ultimately make a determination.” Id. In EX2220
`
`at 52:14-24, Dr. McDuff testified: “I reviewed Dr. Meyer’s opinions and did not
`
`find them persuasive for a finding of commercial success, nor did I see any
`
`evidence that convinced me that this was a commercial success.”
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`-5-
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`
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`Observation #6:
`
`Dr. McDuff testified: “I further understand that evidence of commercial
`
`success is only relevant if there is a nexus between the alleged commercial success
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`and the patentable features of the asserted claims. In other words, the patent owner
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`must show that the commercial success is attributable to the novel parts of a patent
`
`claim, and not on factors that are unrelated or were already known. EX1060, ¶13.
`
`In EX2220 at 49:24-50:4, Dr. McDuff testified that factors that were unrelated or
`
`were already known would include the prior art. In EX2220 at 117:24-118:5, Dr.
`
`McDuff testified that whether sitagliptin or saxagliptin was invented first is “not a
`
`primary consideration here” in “observing poor differentiation in the actual market
`
`where the economic evidence is.” In EX2220 at 50:5-14, Dr. McDuff explained
`
`that “the economic evaluation of commercial success is about assessing the
`
`marketplace as it exists and can be observed” because that is where the “economic
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`evidence” is. In EX2220 at 50:15-25, Dr. McDuff explained that he examined
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`“differentiation in the marketplace as it can be observed” and that he evaluates the
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`“economic matter” as it’s observed in the market,” leaving the Board to decide the
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`“legal issue” of what “legal inference” to draw regarding obviousness.
`
`Observation #7:
`
`Dr. McDuff testified that he neither disputed nor confirmed certain
`
`assertions made by Dr. Meyer. E.g., EX2220 at 21:22-22:3. In EX2220 at 24:17-
`
`25:25, Dr. McDuff testified that “gross sales” do not properly qualify as “sales of
`
`-6-
`
`
`
`Onglyza” because “[t]hey’re not earned revenues and they wouldn’t typically be
`
`described as the overall sales figures[,] not in terms of what is earned and actually
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`booked….” Dr. McDuff also testified that Dr. Meyer failed to compare the
`
`Onglyza sales to anything (EX2220 at 27:13-22), that the IMS promotional data
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`relied upon by Dr. Meyer understates the true promotional expenditures (EX2220
`
`at 31:6-15), and that the understatement would not be expected to be uniform
`
`across products (EX2220 at 31:16-25, 35:14), meaning that saxagliptin’s
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`promotional expenditures may be understated relative to its competitors’
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`promotional expenditures. Dr. McDuff also testified that Dr. Meyer’s Figure 7 is
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`not particularly informative because it “is graphed on a monthly basis,” is “highly
`
`influenced by the amount of marketing or sales in a particular month,” such as the
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`very low amount of sales in the denominator when a product launches.” EX2220 at
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`36:7-39:3. Dr. McDuff also testified that such comparisons based on “the same
`
`calendar year…aren’t apples to apples” because they do not compare promotional
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`efforts based on the number of “years since launch.” EX2220 at 120:6-121:22.
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`Observation #8:
`
`In EX2220 at 27:13-22, 59:15-22, Dr. McDuff testifies that Dr. Meyer relied
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`on products sales “in some abstract, unexplained sense” and that she did not
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`compare sales of Onglyza or Kombiglyze to sales of any other drug, whether gross
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`sales or net sales. Dr. McDuff explained that Dr. Meyer merely provides “a
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`-7-
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`
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`recitation of calculations,” that “she has not compared them to anything,” and that
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`“Dr. Meyer’s lack of any comparison is problematic.” EX2220 at 59:23-61:4,
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`61:16-63:5, 70:17-19. Dr. McDuff explained that whether $2.5 billion in net
`
`revenue is “substantial” depends on the context at issue (EX2220 at 63:9-10, 66:2),
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`and that “in light of [the] comparisons, I don’t think that [the] sales of saxagliptin
`
`are substantial. EX2220 at 64:6-17. Dr. McDuff explained that he “provided
`
`points of comparison to put Dr. Meyer’s calculations into context” in paragraph 18
`
`and elsewhere in his declaration (EX2220 at 69:11-14). Dr. McDuff explained that
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`the points of comparison he provided included other DPP-4 drugs, other drugs used
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`to treat Type 2 diabetes, such as non-insulin anti-diabetic drugs, and other factors.”
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`EX2220 at 70:8-14. Dr. McDuff testified that this “context is important.” EX2220
`
`at 80:7-18. He also explained that it is helpful to look at both DPP-4 comparators
`
`and other NIAD comparators. EX2220 at 76:6-77:13. Dr. McDuff also testified
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`that he did not agree with Dr. Meyer that it was appropriate to focus on
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`comparisons solely to DPP-4 inhibitors to the exclusion of other NIAD
`
`comparators because “[i]t’s very common for there to be separate classes of
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`treatment for the same disease or diagnosis, yet they are in competition with one
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`another, such as D[P]P-4s and other noninsulin antidiabetic drugs.” EX2220 at
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`78:3-79:2. Dr. McDuff also testified: “I think it is not reasonable to ignore the
`
`broader notion of competition and the competition with treatments outside D[P]P-4
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`-8-
`
`
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`inhibitors, I don’t agree with that.” EX2220 at 79:3-12. Dr. McDuff also testified
`
`that a focus on comparing saxagliptin sales only to DPP-4 inhibitors instead of the
`
`broader NIAD market would overstate saxagliptin’s commercial sales because “the
`
`Type 2 diabetes treatment market as a whole is larger than the D[P]P-3 inhibitor
`
`market.” EX2220 at 81:10-18.
`
`Observation #9:
`
`In EX2220 at 42:1-22, Dr. McDuff testified that “My declaration provides
`
`my opinions and they do primarily relate to commercial success and its relation to
`
`the ’186 patent,” that it is “possible that some of my opinions may be cited in
`
`support of other indicia, yet my opinions are generally focused on commercial
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`success as I would think of it, yet they may relate to other indicia as well,” and that
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`he is not offering an opinion on the overall validity of the ’186 patent “[a]s a
`
`conclusory matter,” but that his “opinions may go towards that determination via
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`secondary considerations.”
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`Observation #10:
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`In EX2220 at 75:20-76:2, in answer to a question whether he “studied the
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`relative efforts of AstraZeneca and Novartis to promote and market saxagliptin-
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`containing products and vildagliptin-containing products outside of the U.S.,” Dr.
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`McDuff testified that this “[i]s not something I focused on, nor do I recall seeing
`
`that evaluation in the Meyer declaration.”
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`-9-
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`
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`Observation #11:
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`In EX2220 at 82:5-14, Dr. McDuff testified that he thought sitagliptin had “a
`
`first mover advantage to some degree” that was “substantial enough to understand
`
`and evaluate as one factor that influenced how this market developed.” In EX2220
`
`at 82:15-25, Dr. McDuff testified that “Given the lack of differentiation, relative
`
`lack of differentiation of the competition here, at least among D[P]P-4 inhibitors,
`
`the first mover advantage would tend to be stronger,” but was not absolute, as
`
`evidenced by “Tradjenta over[taking] Onglyza despite the reverse order in launch.”
`
`Dr. McDuff testified that “this class of treatments [DPP-4 inhibitors] is less
`
`differentiated than most pharmaceutical markets,” and that “in light of that lack of
`
`differentiations” sitagliptin’s first mover advantage “was impactful.” EX2220 at
`
`83:1-25. IN EX2220 at 112:7-15, Dr. McDuff testified: “In this market with the
`
`limited differentiation among the products that are competing, I think the first
`
`mover advantage for Merck was more impactful than average.”
`
`Observation #12:
`
`In EX2220 at 91:20-92:10, Dr. McDuff testified that “it’s likely that the
`
`expected cost of commercializing the saxagliptin products were on the greater side
`
`of drug commercialization costs,” that he was “not aware of any specific dollar
`
`figures having been provided by AstraZeneca or Dr. Meyer,” but that he cites
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`“typical costs of drug developments, as well as facts specific to Onglyza and
`
`Kombiglyze XR’s development that allows a determination or an overall
`
`-10-
`
`
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`assessment of what those costs would be.” In EX2220 at 95:15-96:6, Dr. McDuff
`
`testified that he had not seen data “provided by AstraZeneca or Dr. Meyer that
`
`would allow for calculation” of the exact amount expended to develop Onglyza
`
`and Kombiglyze, but that he had provided information about “what is typical for
`
`commercialization costs and have indicated that Onglyza and Kombiglyze together
`
`have similar characteristics as the drugs that have been studied and would thus
`
`have similar or possibly greater commercialization costs relative to figures from
`
`the published literature.” In EX2220 at 97:6-16, Dr. McDuff testified that he had
`
`enough information about efforts to develop and commercialize saxagliptin to
`
`opine under oath that it is likely that the cost of development was on the greater
`
`side of pharmaceutical development costs based on the evidence he reviewed, but
`
`that he would have been open to considering evidence about actual development
`
`costs had AstraZeneca chosen to provide it.
`
`Observation #13:
`
`In EX2220 at 100:4-14, Dr. McDuff testified that he agreed that,
`
`numerically speaking, the promotional spending reported by IMS for sitagliptin
`
`was approximately two times that reported by IMS for Onglyza and Kombiglyze.
`
`However, Dr. McDuff also testified that “marketing for Onglyza and Kombiglyze
`
`was above average relative to sales in comparison to other D[P]P-4 inhibitors” for
`
`its time period. EX2220 at 148:21-25. Dr. McDuff further testified that marketing
`
`-11-
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`
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`expenditures for Onglyza and Kombiglyze was less “on a dollar basis” than for the
`
`Januvia product family from 2009 to 2015, but that the same was not true “[o]n a
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`share of voice verses share[ of] prescription basis.” EX2220 at 149:1-8.
`
`Observation #14:
`
`In EX2220 at 123:12-20, Dr. McDuff testified that both the decline in sales
`
`that started in 2012 and the 2016 FDA warning “go towards supporting the overall
`
`notion of limited future opportunity” for saxagliptin. In EX2220 at 125:8-126:4,
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`Dr. McDuff testified that it “may have been” known to prescribers prior to the
`
`issuance of the FDA warning in 2016 that patients receiving saxagliptin “had a
`
`greater risk of hospitalization for heart failure,” but that even if the issue were
`
`known, the FDA warning would still have an effect because “it’s a matter of
`
`degree and a matter of signal” when the FDA “at some point elevates” the risk “to
`
`the level where the FDA evaluates it and issues a warning.” Dr. McDuff testified
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`that even if there were “some impact from the scientific evidence,” he would
`
`expect a “further impact from the FDA warning.” EX2220 at 125:13-126:4.
`
`Observation #15:
`
`In EX2220 at 132:14-135:5, Dr. McDuff testified: “As indicated in my
`
`declaration and as described in my previous response, I looked at the discounts for
`
`Novartis as a company. They did not separately report discount[s] for vildagliptin,
`
`but I use them as a representative benchmark.” In EX2220 at 131:14-132:13, Dr.
`
`McDuff referenced paragraphs 41-13 of his declaration and testified that Novartis
`
`-12-
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`
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`is the manufacturer of vildagliptin and is “a representative benchmark for not only
`
`the company that is the competitor company selling the competitor product, but as
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`a company selling this type of product.” Dr. McDuff testified that he analyzed the
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`discounts for Onglyza and Kombiglyze “relative to not only my experience
`
`analyzing pharmaceutical discounts” and also compared to “the best information I
`
`could find on a benchmark… It was the company selling vildagliptin.” EX2220 at
`
`133:25-134:7. Dr. McDuff testified that the Onglyza and Kombiglyze discounts
`
`were “large relative to” his experience analyzing pharmaceutical discounts
`
`generally. Dr. McDuff testified that is “notable how much lower those
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`[vildagliptin health care plans and program rebates] are compared to Onglyza and
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`Kombiglyze” because “[i]t’s an order of magnitude lower, from a company that is
`
`“representative not only of the industry generally, but representative of the
`
`company that sells vildagliptin.” EX2220 at 135:3-12. Dr. McDuff explained that
`
`although the Novartis data is not isolated to “vildagliptin specifically, which was
`
`not available,” that it is “either the case that competitor D[PP]-4 products don’t
`
`have as big a discount as Onglyza or Kombiglyze, which is my expectation, but if
`
`they did, again, because I’ve been using the best proxy that I can, [it] just further
`
`indicates the lack of differentiation in the market. So either way the large discount
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`for Onglyza and Kombiglyze indicate a relative lack of nexus to the patent-in-suit.”
`
`EX2220 at 135:12-136:13
`
`-13-
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`
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`Observation #16:
`
`In EX2220 at 140:6-141:11, Dr. McDuff was asked to examine a partial
`
`excerpt of an undated deposition transcript marked as Exhibit 2218 that Patent
`
`Owner represented was read into a trial record on September 1, 2016. In EX2220
`
`at 144:4-9, Dr. McDuff was asked to examine for the first time a document marked
`
`as Exhibit 2219 that Patent Owner represented as a CVS Caremark Value
`
`Formulary effective as of October 1, 2016. Dr. McDuff testified that he could not
`
`confirm whether either of these documents was what Patent Owner represented
`
`them to be because he had no independent knowledge about the document.
`
`EX2220 at 141:4-11, 144:10-15. Dr. McDuff was asked to speculate regarding the
`
`relationship between EX2218 and EX2219. EX2220 at 145:6-146:7. Dr. McDuff
`
`answered that he did not see any price comparison in the documents, that the
`
`document provided “limited context,” and that the questioning attorney’s
`
`speculation “may be possible.” Id.
`
`Observation #17:
`
`In EX2220 at 149:1-150:6, Dr. McDuff testified that the marketing
`
`expenditures for Onglyza and Kombiglyze were not lower than expenditures for
`
`the Januvia product family from 2009 to 2015 when the relative share of
`
`prescriptions was taken into account, and that a calendar month comparison “does
`
`not take into account the differences in time of launch.” In EX2220 at 151:22-
`
`152:10, Dr. McDuff testified that comparing the numerical promotional spending
`
`-14-
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`
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`for Tradjenta vs. Onglyza was not “a valid comparison” because “[i]t cuts off
`
`significant early promotional expenditures for Onglyza in the two years before
`
`2011, and looking at their market share as of 2015, the’re more comparable. It’s
`
`13.7 percent for Tradjenta and 13.1 percent for Onglyza and Kombiglyze.” In
`
`EX2220 at 152:12-14, Dr. McDuff testified, “Looking at those values, I’d say they
`
`are more occasional as opposed to one being significantly different than the other.”
`
`See also EX2220 at 152:19-25 (2015 market share of 13.7 for Tradjenta vs. 13.1
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`for Onglyza family).
`
`
`
`
`
`Date: 19 December 2016
`
`
`
`
`
`
`
`Respectfully,
`
`
`
`/ Richard Torczon /
`Richard Torczon, Reg. No. 34,448
`Counsel for Mylan
`
`-15-
`
`
`
`CERTIFICATE OF SERVICE
`37 CFR §42.6(e)
`
`I certify that, on 19 December 2016, this PETITIONERS’ RESPONSE TO
`
`MOTION FOR OBSERVATIONS REGARDING THE CROSS-EXAMINATION
`
`OF DEFOREST MCDUFF was served on AstraZeneca at the following service
`
`electronic addresses:
`
`Charles E. Lipsey
`
`charles.lipsey@finnegan.com
`
`Eric E. Grondahl
`
`egrondahl@mccarter.com
`
`John D. Livingstone
`
`john.livingstone@finnegan.com
`
`Anthony A. Hartmann
`
`anthony.hartmann@finnegan.com
`
`M. David Weingarten
`
`david.weingarten@finnegan.com
`
`Nicole A. Conlon
`
`nicole.conlon@finnegan.com
`
`Daniel M. Silver
`
`dsilver@mccarter.com
`
`Kassandra M. Officer
`
`kassandra.officer@finnegan.com
`
`on Wockhardt at the following service electronic addresses:
`
`Frederick R. Ball
`
`FRBall@duanemorris.com
`
`Patrick C. Gallagher
`
`PCGallagher@duanemorris.com
`
`on Teva at the following service electronic addresses:
`
`Iain A. McIntyre
`
`IMcIntyre@carlsoncaspers.com
`
`Gary J. Speier
`
`GSpeier@carlsoncaspers.com
`
`-16-
`
`
`
`on Aurobindo at the following service electronic addresses:
`
`Sailesh K. Patel
`
`SPatel@schiffhardin.com
`
`Joel Wallace
`
`JWallace@schiffhardin.com
`
`George Yu
`
`GYu@schiffhardin.com
`
`
`and on Sun/Amneal at the following service electronic addresses:
`
`Samuel S. Park
`
`spark@winston.com
`
`Andrew R. Sommer
`
`asommer@winston.com
`
`
`Dated: 19 December 2016
`
`
`
`
`
`/ Richard Torczon /
`Richard Torczon, Reg. No. 34,448
`
`
`
`
`
`-17-