PATENT
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicant(s)
`
`Myers et a1.
`
`Examiner:
`
`Janet L. Epps—Smith
`
`Serial No.:
`
`12/537,571
`
`Group Art Unit:
`
`1633
`
`Confirmation No.:
`
`5 630
`
`Docket:
`
`1 199-82
`
`Filed:
`
`For:
`
`August 7, 2009
`
`Dated:
`
`February 29, 2012
`
`Sublingual and Buccal Film
`Compositions
`
`Commissioner for Patents
`
`P.O. BOX 1450
`Alexandria, Virginia 22313-1450
`
`Certificate of EFS-Web Transmission
`I hereby certify that this correspondence is being transmitted to the U.S.
`Patent and Trademark Office Via the Office's electronic filing system.
`Dated: Febma
`29 2012
`
`Signature: Christine Briscoe/cbriscoe/
`
`AMENDMENT AND RESPONSE
`
`Sir:
`
`In response to the office action dated August 31, 2011, a response to which is due by
`
`February 29, 2012 in View of the concurrently filed petition for three month extension of
`
`time, please amend the application as follows:
`
`Amendments to the Claims begin on page 2 of this paper.
`
`Remarks begin on page 7 of this paper.
`
`P3991
`
`BDSI EXHIBIT 1007
`
`Page 1
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`

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`Applicants: Myers et al.
`Serial No.: 12/537,571
`Docket No.: 1199-82
`
`Page 2
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`Amendments to the Claims:
`
`This listing of claims shall replace all previous listings in this application:
`
`1.
`
`(Currently Amended) A film dosage composition comprising:
`
`a. A polymeric carrier matrix;
`
`b. A therapeutically effective amount of buprenorphine or a pharmaceutically
`
`acceptable salt thereof;
`
`e. A therapeutically effective amount of naloxone or a pharmaceutically
`
`acceptable salt thereof; and
`
`d. A buffer in an amount to provide a local pH e—f @ said composition of a value
`
`sufficient to optimize absorption of said buprenorphine= wherein said local pH
`
`is from about 2 to about 3 .5 in the presence of saliva.
`
`(Canceled).
`
`(Currently Amended) The composition of claim 1 2, wherein the local pH of said
`
`composition is from about 3 to about 3+5 [[4]].
`
`(Original) The composition of claim 1, wherein said film dosage composition
`
`provides a bioequivalent absorption of buprenorphine to that of a tablet having an
`
`equivalent amount of buprenorphine or a ph armaceutically acceptable salt thereof.
`
`(Original) The composition of claim 1, wherein said polymeric carrier matrix
`
`comprises at least one polymer in an amount of at least 25% by weight of said
`
`composition.
`
`(Original) The composition of claim 1, wherein said buffer is present in an amount of
`
`from about 2:1 to about 1:5 by weight of buffer to buprenorphine.
`
`(Original) The composition of claim 1, wherein said polymeric carrier matrix
`
`comprises at least one self-supporting film forming polymer.
`
`(Original) The film dosage composition of claim 1, wherein said buprenorphine is
`
`present in an amount of from about 2 mg to about 16 mg per dosage.
`
`(Original) The film dosage composition of claim 1, wherein said buffer comprises
`
`sodium citrate, citric acid, and combinations thereof.
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`Page 2
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`Page 2
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`

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`Applicants: Myers et al.
`Serial No.: 12/537,571
`Docket No.: 1199-82
`
`Page 3
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`10. (Original) The film dosage composition of claim l , wherein said buffer comprises
`
`acetic acid, sodium acetate, and combinations thereof.
`
`11. (Currently Amended) A film dosage composition comprising:
`
`a. A polymeric carrier matrix;
`
`b. A therapeutically effective amount of buprenorphine or a pharmaceutically
`
`acceptable salt thereof;
`
`c. A therapeutically effective amount of naloxone or a pharmaceutically
`
`acceptable salt thereof; and
`
`d. A buffer in an amount sufficient to inhibit the absorption of said naloxone,
`
`while also optimizing absopption of said buprenopphine when administered
`
`orally.
`
`12. (Currently Amended) The composition of claim 11, wherein said composition has a
`
`local pH of about 2 to about 3_5 [[4]].
`
`13. (Currently Amended) The composition of claim 11, wherein said composition has a
`
`local p_H of about 3 to about 3.5 said—buffer—is—present—in—an—amount—suffieient—to
`
`14. (Currently Amended) The composition of claim 13, wherein a—t—herapeut—iea—l—l-y
`
`adequateabsofiation—ef—buprenefiahineeempflses—said buffer is present in an amount
`
`sufficient to provide—a bioequivalent level of absorption of buprenorphine as a tablet
`
`having an equivalent amount of buprenorphine or a pharmaceutically acceptable salt
`
`thereof.
`
`15. (Currently Amended) A film dosage composition comprising:
`
`a. A polymeric carrier matrix;
`
`b. A therapeutically effective amount of buprenorphine or a pharmaceutically
`
`acceptable salt thereof;
`
`c. A therapeutically effective amount of naloxone or a pharmaceutically
`
`acceptable salt thereof; and
`
`d. A buffering system;
`
`wherein said buffering system comprises a buffer capacity sufficient to maintain
`
`the ionization of naloxone during the time which said composition is in the oral
`
`Page 3
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`Page 3
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`

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`Applicants: Myers et al.
`Serial No.: 12/537,571
`Docket No.: 1199-82
`
`Page 4
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`cavity of a user, and also sufficient to optimize the absogption of said
`
`buprenorphine.
`
`16. (Currently Amended) The composition of claim 15, wherein said composition has a
`
`local pH of about 2 to about 3+5 [[4]].
`
`17. (Currently Amended) A method of treating narcotic dependence of a user,
`
`comprising the steps of:
`
`a. providing a composition comprising:
`
`i. A polymeric carrier matrix;
`
`ii. A therapeutically effective amount of buprenorphine or a
`
`pharmaceutically acceptable salt thereof;
`
`iii. A therapeutically effective amount of naloxone or a pharmaceutically
`
`acceptable salt thereof; and
`
`iv. A buffer in an amount to provide a local pH of about 2 to about 3.5 for
`
`said composition of a value sufficient to optimize absorption of said
`
`buprenorphine and also sufficient to inhibit absorption of said
`
`naloxone; and
`
`b. administering said composition to the oral cavity of a user.
`
`18. (Original) The composition of claim 17, wherein said method provides a
`
`bioequivalent absorption of buprenorphine to that of a tablet having an equivalent
`
`amount of buprenorphine or a pharmaceutically acceptable salt thereof.
`
`19. (Currently Amended) The method of claim 17, wherein said composition has a local
`
`pH of about ; [[2]] to about 3+5 [[4]].
`
`20. (Original) The method of claim 17, wherein said film dosage composition is
`
`administered to the user through buccal administration, sublingual administration, and
`
`combinations thereof.
`
`21. (Original) The method of claim 17, wherein said film dosage composition remains in
`
`the oral cavity of the user for a period of at least 1 minute.
`
`22. (Original) The method of claim 17, wherein said film dosage composition remains in
`
`the oral cavity of the user for a period of between about 1 and 1.5 minutes.
`
`Page 4
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`Page 4
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`

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`Applicants: Myers et al.
`Serial No.: 12/537,571
`Docket No.: 1199-82
`
`Page 5
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`23.
`
`24.
`
`(Original) The method of claim 17, wherein said film dosage composition remains in
`
`the oral cavity of the user for a period of up to 3 minutes.
`
`(Currently Amended) A process of forming a film dosage composition comprising
`
`the steps of:
`
`a.
`
`casting a film-forming composition, said film-forming composition
`
`comprising:
`
`i. A polymeric carrier matrix;
`
`ii. A therapeutically effective amount of buprenorphine or a
`
`pharmaceutically acceptable salt thereof;
`
`iii. A therapeutically effective amount of naloxone or a pharmaceutically
`
`acceptable salt thereof; and
`
`iv. A buffer in an amount to provide a local pH of said composition of a
`
`value sufficient to optimize absorption of said buprenorphine and also
`
`sufficient to inhibit absorption of said naloxone; and
`
`b. drying said film—forming composition to form a self—supporting film dosage
`
`composition.
`
`25.
`
`26.
`
`(Currently Amended) The process of claim 24, wherein said composition has a local
`
`pH of about 2 to about Q [[4]].
`
`(Currently Amended) A film dosage composition comprising a therapeutically
`
`sufficient amount of buprenorphine or a pharmaceutically acceptable salt thereof and
`
`a therapeutically sufficient amount of naloxone or a pharmaceutically acceptable salt
`
`thereof, said film dosage composition having a bioequivalent release profile as a
`
`tablet containing about 2 times the amount of buprenorphine or a pharmaceutically
`
`acceptable salt thereof, and wherein said composition provides a local pH of from
`
`about 2 to about 3.5.
`
`27.
`
`(Original) An orally dissolving film formulation comprising buprenorphine and
`
`naloxone, wherein said formulation provides an in vivo plasma profile having a Cmax
`
`of between about 0.624 ng/rnl and about 5.638 ng/rnl for buprenorphine and an in
`
`vivo plasma profile having a Cmax of between about 41.04 pg/rnl to about 323.75
`
`pg/ml for naloxone.
`
`Page 5
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`Page 5
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`

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`Applicants: Myers et al.
`Serial No.: 12/537,571
`Docket No.: 1199-82
`
`Page 6
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`28. (Original) The formulation of claim 27, wherein said formulation provides a mean
`
`AUC of between about 5.431 hr.ng/ml to about 56.238 hr.ng/ml for buprenorphine.
`
`29. (Original) The formulation of claim 27, wherein said formulation provides a mean
`
`AUC of between about 102.88 hr.pg/rn1 to about 812.00 hr.pg/m1 for naloxone.
`
`30. (Original) The formulation of claim 27, wherein said formulation comprises about 2
`
`to about 16 mg of buprenorphine or a salt thereof.
`
`31. (Original) The formulation of claim 27, wherein said formulation comprises about
`
`0.5 to about 4 mg of naloxone or a salt thereof.
`
`Page 6
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`Page 6
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`

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`Applicants: Myers et al.
`Serial No.: 12/537,571
`Docket No.: 1199-82
`
`Page 7
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`REMARKS
`
`The present application has been amended. Specifically, the claims have been
`
`amended to recite a particular local pH value and/or to recite that the buffer optimizes
`
`absorption of buprenorphine while also inhibiting absorption of the naloxone. Support for
`
`these amendments may be found, for example, at paragraphs [0013-17] and in the claims of
`
`the application as filed. It is noted that terms such as “optimize” and “inhibit” are defined in
`
`the application. No new matter is introduced through this Amendment.
`
`
`Brief Description of the Invention
`
`To aid the Examiner’s understanding, the Applicant believes that it is beneficial to
`
`provide a concise explanation of the invention. Delivery of compounds such as
`
`buprenorphine and naloxone was previously known, however, the previously-accepted form
`
`of the delivery is in the form of a tablet (e. g., a Suboxone® tablet). The present invention is
`
`directed to the formation of a suitable film product that provides a certain release profile and
`
`in some embodiments, is bioequivalent result to, for example, a Suboxone® tablet. The
`
`desired result is a product that provides a Cmax that is 80- 125% the level provided by, for
`
`example, the Suboxone® tablet at the same dosage levels of the buprenorphine and the
`
`naloxone.
`
`The desired film product includes the delivery of buprenorphine and naloxone
`
`together. The film is either a single-layered film or a multi-layered film. In either case, it is
`
`desired to provide a product that is cognizant of both the buprenorphine and naloxone. That
`
`is, the absorption of the buprenorphine should be “optimized” (as defined at paragraph [0019]
`
`of the application) to provide a desired level of absorption, but at the same time the
`
`absorption of the naloxone should be inhibited to provide a minimal, if any, level of
`
`absorption. As explained in detail throughout the application, the present applicants have
`
`discovered that the film product should include a buffer that provides a specific buffer
`
`capacity to the film in order to achieve the desired result.
`
`As set forth in the application as filed, according to pH partition theory, one would
`
`expect that saliva (which has a local pH of about 6.5) would maximize the absorption of both
`
`actives, given their respective pKa levels. See, for example, the Examples in the application
`
`Page 7
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`Page 7
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`

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`Applicants: Myers et al.
`Serial No.: 12/537,571
`Docket No.: 1199-82
`
`Page 8
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`as filed. As generally understood, absorption of an active depends on the available unionized
`
`form of the active. Thus, as the local pH of the surrounding environment is lowered, basic
`
`actives will be more ionized, and less will be available for absorption.
`
`Thus, it would be contrary to think of lowering the pH from 6.5 to pH 5.5, and
`
`especially to pH 3.5, given the above-mentioned theory. However, as explained in the
`
`application as filed, the absorption of the buprenorphine was increased by dropping the pH
`
`from 6.5 to 5.5. The absorption at a pH of 5.5 was, however, higher than desired (i.e., it was
`
`“maximized”, not “optimized”). Extrapolating this further, it was surprising to find that the
`
`absorption for the buprenorphine decreased to a desirable level upon further lowering of the
`
`pH. As explained in the application as filed and in the Examples, controlling the local pH by
`
`providing a buffer having a specific buffer capacity in the film compositions of the present
`
`invention provides a system in which the desired release and/or absorption of the components
`
`is achieved.
`
`For film products including both buprenorphine and naloxone, it was particularly
`
`surprising to find that both may be included in one film by providing a buffer having a pH of
`
`from about 2 to about 3.5. At this buffer capacity, it was found that the absorption of the
`
`buprenorphine may be optimized to a desirable level, while at the same time the absorption of
`
`the naloxone may be inhibited to a desirable level.
`
`The present applicants have discovered that following pH partition theory actually
`
`does not result in a suitable product. This discovery was completely surprising and was not
`
`known prior to the invention. The claims have been amended where applicable to reflect the
`
`essence of the invention.
`
`Response to Rejection
`
`In the Office Action, the Examiner rejected claims 1, 4, 5, 7-10, 15, 17 and 20-24
`
`under 35 U.S.C. §102(b) as allegedly anticipated by Oksehe (WO 2008/025791, counterpart
`
`US 2010/0087470). The Examiner alleged that Oksehe discloses the use of modified
`
`cellulose materials to administer buprenorphine and naloxone orally. The Examiner also
`
`pointed to the use of citric acid, tartaric acid, phosphoric acid, hydrochloric acid and maleic
`
`acid.
`
`Page 8
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`Page 8
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`

`

`Applicants: Myers et al.
`Serial No.: 12/537,571
`Docket No.: 1199-82
`
`Page 9
`
`The applicant respectfiilly traverses the instant rejection, and notes that the claims
`
`recite that the buffering system is sufficient to “optimize” the absorption of buprenorphine.
`
`To clarify the claims, the Applicant has amended claim 1 to recite that the pH for the
`
`buprenorphine is from 2 to 3.5. This pH allows for absorption of buprenorphine, but, in the
`
`case where naloxone is present, its absorption is minimized. The naloxone is included in the
`
`formulation, for example, as an antagonistic component if the product is injected or snorted
`
`by a product abuser, but its effect is minimized when the product is taken as intended, such as
`
`orally. As explained above, a pH of about 5.5 may be usefiil in maximizing absorption,
`
`however, not “optimizing” the absorption as defined in the application as filed. Even further,
`
`for the other claims as pending, the claims recite the use ofa buffer that is suitable to not only
`
`optimize the absorption of buprenorphine, but also at the same time to inhibit the absorption
`
`of the naloxone.
`
`The mere disclosure of the use of a pH modifier, for example, citric acid, is not the
`
`same as providing a buffer system that is sufficient to provide a buffer capacity suitable to
`
`optimize the absorption of the buprenorphine, let alone inhibit the absorption of the naloxone.
`
`Oksche completely fails to acknowledge that the pH of the system plays any role in the
`
`optimization or inhibition of the actives to be administered. Oksehe merely discloses the
`
`inclusion of “suitable pH modifiers”, without providing any discussion as to their use, their
`
`amount, the resulting pH levels, or their relation to the absorption of the buprenorphine.
`
`Oksche completely failed to recognize that providing a particular buffer capacity would be
`
`beneficial or important in the absorption of the buprenorphine. Oksche does not disclose any
`
`particular buffer capacity, either expressly or implicitly. Oksche only generally discloses
`
`flavoring agents, pH modifiers, and taste masking agents, each of which may have a
`
`pronounced effect on the pH of the material.
`
`The present application is based upon the discovery that the delivery and absorption
`
`of buprenorphine can be optimized to a desired level through administration via a film if the
`
`pH is balanced appropriately.
`
`Since Oksche fails to disclose the present limitation of a buffer capacity suitable to
`
`optimize the absorption of the buprenorphine, it cannot anticipate the claims as pending.
`
`Page 9
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`Page 9
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`

`

`Applicants: Myers et al.
`Serial No.: 12/537,571
`Docket No.: 1199-82
`
`Page 10
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`Next, in the Office Action, claims l-3l were rejected under 35 U.S.C. §l03(a) as
`
`allegedly obvious over Oksche. The Examiner acknowledged that the reference fails to
`
`disclose the specific range of pH in the claims. However, the Examiner alleged that it would
`
`have been obvious to identify the optimal pH in an effort to provide optimal absorption of
`
`both the buprenorphine and the naloxone. In short, the Examiner alleged that the pH range
`
`would be a matter of routine experimentation.
`
`The Applicant respectfillly traverses the instant rejection and notes that the general
`
`disclosure in Oksche of a buffer is not sufficient to establish a primafacz'e case of
`
`obviousness. As an initial matter, it appears that the Examiner has set forth an “obvious to
`
`try” rejection. In order to establish that it would have been obvious to try certain variations,
`
`there must be a “finite number” of choices to choose from, which provide predictable results.
`
`Here, there are a significant number of pH ranges to choose from, ranging from 1-14 and
`
`including all fractions thereof. In addition, there are a significantly high number of potential
`
`buffers from which to choose, including acids, bases, and combinations thereof. Oksche
`
`provides absolutely no teaching as to what a suitable buffer that can provide a suitable buffer
`
`capacity is, nor is there simply a finite number of choices available.
`
`Even further, for reasons stated in detail in the application, the proper buffering
`
`capacity is not one of routine experimentation nor is it one that can be predictably selected by
`
`one of ordinary skill in the art. Those skilled in the art would have simply relied upon pH
`
`partition theory and selected a buffering capacity that follows this theory — for example, a pH
`
`commensurate with the pKa of the active. However, as explained in the application,
`
`following pH partition theory did not result in a suitable product and the proper buffer
`
`capacity actually varied from that expected by the theory. Thus, the buffer capacity suitable
`
`to optimize the absorption of the buprenorphine and, at the same time, to inhibit the
`
`absorption of the naloxone, is not predictable.
`
`The present inventors have undertaken significant experimentation to determine the
`
`conditions to effectively and efficiently deliver a suitable dosage of buprenorphine and, at the
`
`same time, to effectively and efficiently inhibit the absorption of naloxone. The inventors
`
`have determined that the buffer selected and the buffer capacity used in the film has a
`
`significant and dramatic affect on the absorption of actives. However, the arrival at this
`
`Page 10
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`Page 10
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`

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`Applicants: Myers et al.
`Serial No.: 12/537,571
`Docket No.: 1199-82
`
`Page 11
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`invention is not simply limited to mere selection of pH ranges, and must take into account the
`
`Cmax and AUC values for the product.
`
`As can be seen, one must consider a number of variables and consider many different
`
`features in order to consider the absorption of the buprenorphine “optimized”, as presently
`
`claimed, so as to provide a bioequivalent release level as that of a Suboxone® tablet having
`
`similar levels of buprenorphine. The particular buffering levels and amount play a critical
`
`role in determining the effectiveness of the composition. The buffer capacity must be
`
`considered so as to provide the desired absorption levels of both actives. The discovery of
`
`the desirable buffer capacity was certainly not contemplated in Oksche and would not have
`
`been predictable.
`
`The claims include both components to be together in a single film, with a buffer
`
`capacity that is suitable for both. The inventors have found that the two components may be
`
`used together with a single buffer capacity that optimizes the absorption of the buprenorphine
`
`but concurrently inhibits the absorption of the naloxone. This discovery was certainly not
`
`disclosed or contemplated in Oksche.
`
`Oksche fails to disclose or suggest any buffering capacity and, in fact, fails to even
`
`acknowledge that buffering capacity can play a role in the relative absorptions of the
`
`components. Oksche merely states that buffers can be used, but includes nothing further.
`
`This general disclosure of a buffer is not sufficient to render obvious claims that require a
`
`particular buffer capacity to optimize the absorption of buprenorphine and inhibit the
`
`absorption of naloxone.
`
`The Examiner alleged that modification of the pH values would be obvious.
`
`However, the Applicant respectfiilly disagrees and notes that there has been undertaken a
`
`significant course of experimentation to determine how pH can have an effect on the
`
`absorption (which is summarized in the application as filed). Oksche merely discloses that
`
`certain additives may be used, including acids as well as bases. One of ordinary skill in the
`
`art would therefore be led to believe that any particular pH value, whether neutral, acidic or
`
`basic, would be acceptable based upon the disclosure of Oksche. Further, there is no reason
`
`to believe, based upon the teachings of Oksche, that pH would even play any role in the
`
`effectiveness of the composition.
`
`Page 11
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`Page 11
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`

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`Applicants: Myers et al.
`Serial No.: 12/537,571
`Docket No.: 1199-82
`
`Page 12
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`Some ofthe claims recite a particular Cmax value for both the buprenorphine m the
`
`naloxone — which is not disclosed or even suggested in Oksche. Oksche is completely silent
`
`as to the Cmax for the naloxone, and merely discusses values for the buprenorphine.
`
`Summarizing the invention, the present invention includes embodiments that provide a
`
`bioequivalent release and absorption as that of a Suboxone® tablet, both for the
`
`buprenorphine and the naloxone, which is not disclosed in Oksche.
`
`At best, Oksche generally discloses that acids and bases may be used in the system,
`
`but does not even consider the pH effect on the absorption, let alone varying pH values in one
`
`composition.
`
`As explained above, the present applicants have discovered that the suitable buffer
`
`capacity actually differs from that which would be expected from pH partition theory. For
`
`example, the buffer capacity for a product including both the buprenorphine and naloxone
`
`would be one that minimizes the absorption of the naloxone but optimizes the absorption of
`
`the buprenorphine — a concept not disclosed nor considered by Oksche. For example, the
`
`present inventors have discovered that at a pH of about 2—3.5, the relative absorptions can be
`
`controlled effectively. Alternatively, if the pH of the formulation is 2-3.5, the desired
`
`absorption profile may be achieved for buprenorphine while minimizing absorption of the
`
`naloxone.
`
`One of ordinary skill in the art reading Oksche would not be led to believe that pH
`
`would play any role in the absorption. Even further, with respect to those claims including
`
`buprenorphine and naloxone, one of ordinary skill in the art certainly would not believe that
`
`varying local pH values would have any determinable or noticeable effect. There is no
`
`rational basis to modify Oksche to arrive at the presently claimed invention, and it would not
`
`be predictable to one of ordinary skill in the art to arrive at the claimed invention. For these
`
`reasons, these claims including the dual-region composition are allowable over Oksche.
`
`There is no rational basis to arrive at the presently claimed invention based upon
`
`Oksche. Further, based upon the experimentation undertaken by the Applicants, and
`
`summarized in the application, the results obtained were certainly not predictable. Oksche
`
`Page 12
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`Page 12
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`Applicants: Myers et al.
`Serial No.: 12/537,571
`Docket No.: 1199-82
`
`Page 13
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`states nothing about the buffer capacity playing any role whatsoever in the optimum
`
`absorption, and one of ordinary skill in the art would not think it plays any role. There would
`
`be no reason to modify Oksche to arrive at any of these specific limitations as presently
`
`claimed. As such, claims 1-31 are not obvious over Oksche for a multitude of reasons.
`
`Information Disclosure Statement
`
`The Applicant is submitting herewith an Information Disclosure Statement, citing
`
`several references. Included in this submission is the citation of US. Publication No.
`
`2011/0262522, which specifically claims pH ranges that are outside those presently claimed.
`
`In fact, based upon the disclosure ofthis reference, it would not be obvious to those of
`
`ordinary skill in the art to make or use the presently-claimed invention.
`
`Conclusion
`
`The fees for a three month extension of time is also due with this submission, to be
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`charged to Deposit Account No. 08—2461. In addition, the fee for a late filed IDS may also be
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`charged to the same Deposit Account. If any additional fees are due, the Commissioner is
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`hereby authorized to charge payment any fees associated with this communication, or credit
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`any overpayment, to Deposit Account No. 08-2461. Such authorization includes
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`authorization to charge fees for extensions oftime, if any, under 37 CPR § l.l7 and also
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`should be treated as a constructive petition for an extension of time in this reply or any future
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`reply pursuant to 37 C.F.R. § 1.136.
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`If there are any questions or if additional information is required, the Examiner is
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`respectfillly requested to contact Applicant’s attorney at the number listed below.
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`Respectfully submitted,
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`/Jon A. Chiodo/
`Jon A. Chiodo
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`Registration No.: 52,739
`Attorney for Applicant(s)
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`HOFFMANN & BARON, LLP
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`6900 Jericho Turnpike
`Syosset, New York 11791
`(973) 331—1700
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