Ex Parte Lambino et alDownload PDFBoard of Patent Appeals and InterferencesJun 30, 201011113937 (B.P.A.I. Jun. 30, 2010) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES ____________________ Ex parte JOHNSON & JOHNSON CONSUMER COMPANIES, INC. ____________________ Appeal 2009-013144 Application 11/113,937 Technology Center 3700 ____________________ Decided: June 30, 2010 ____________________ Before RICHARD E. SCHAFER, JAMESON LEE, and RICHARD TORCZON, Administrative Patent Judges. LEE, Administrative Patent Judge. DECISION ON APPEAL A. STATEMENT OF THE CASE This is a decision on appeal by the real party in interest Johnson & Johnson Consumer Companies, Inc. (“J & J”) under 35 U.S.C. § 134(a) from a final rejection of claims 1-24. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. Appeal 2009-013144 Application 11/113,937 2 References Relied on by the Examiner Rosenberg et al. (“Rosenberg”) 5,910,147 Jun. 8, 1999 Connelly et al. (“Connelly”) 6,689,100 Feb. 10, 2004 Cormier et al. (“Cormier”) 2002/0128599 Sep. 12, 2002 Skover 2003/0078518 Apr. 24, 2003 Lastovich et al. (“Lastovich”) 2004/0064087 Apr. 1, 2004 The Rejections on Appeal The Examiner rejected claims 19 and 21-24 under 35 U.S.C. § 102(b) as anticipated by Lastovich. The Examiner rejected claims 1-3, 8, and 9 under 35 U.S.C. § 103(a) as unpatentable over Skover and Lastovich. The Examiner rejected claims 4-7 under 35 U.S.C. § 103(a) as unpatentable over Skover, Lastovich, and Cormier. The Examiner rejected claims 10-16 and 18 under 35 U.S.C. § 103(a) as unpatentable over Rosenberg and Connelly. The Examiner rejected claim 17 under 35 U.S.C. § 103(a) as unpatentable over Rosenberg, Connelly, and Lastovich. The Examiner rejected claim 20 under 35 U.S.C. § 103(a) as unpatentable over Lastovich and Cormier. The Invention The invention relates to a method and device for treating acne. (Spec. 1:17-19.) The device includes a microprotrusion member that is pressed against a patient’s skin with a pressure that is sufficient to pierce a layer of skin known as the stratum corneum. (Id. at 1:21-25.) Appeal 2009-013144 Application 11/113,937 3 Claim 1 is reproduced below (App. Br. 8 Claims App’x.):1 A method of treating acne, wherein said method comprises piercing the stratum corneum of skin in need of such treatment with a stratum corneum-piercing device, said device comprising a microprotrusion member having a skin-contacting surface and plurality of stratum corneum- piercing microprotrusions thereon, wherein said device provides an impact pressure when applied to said skin of from about 0.5 lbs/cm2 to about 7 lbs/cm2. B. ISSUES 1. Has J & J shown that the Examiner was incorrect in finding that Lastovich anticipates a devices that provides an impact pressure to skin of from about 0.5 lbs/cm2 to about 7 lbs/cm2? 2. Has J & J shown that the Examiner erred in determining that a person of ordinary skill in the art would have concluded that providing an impact pressure of 0.5 lbs/cm2 to about 7 lbs/cm2 would have been obvious based on the teachings of the prior art? 3. Has J & J shown that the Examiner erred in determining that a person of ordinary skill in the art would have recognized that the teachings of Rosenberg and Connelly may be combined? 4. Has J & J shown that the Examiner erred in determining that claim 20 is obvious in light of the teachings of Lastovich and Cormier? 1 Claim 1 has been reproduced in a manner that complies with 37 C.F.R. § 1.75(i) (“[w]here a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation.”). Appeal 2009-013144 Application 11/113,937 4 C. FINDINGS OF FACT 1. Skover generally discloses a method of treating skin (Skover Abstract), which includes creating an opening in the stratum corneum (id. at 2: ¶ 0019). 2. Lastovich discloses an abrader device for abrading and penetrating the stratum corneum of skin. (Lastovich Abstract; 3: ¶ 0037.) 3. Lastovich describes that the amount of pressure supplied by the device “may be controlled to provide optimum reproducible abrasion of the desired area of the skin.” (Id. at 2: ¶ 0015.) 4. Lastovich also specifies that the amount of pressure is selected so as to sufficiently penetrate the stratum corneum while not so great to as to penetrate other epidermal layers of skin. (Id. at 6: ¶ 0066.) 5. Lastovich further describes that the appropriate pressure supplied is determined as a matter of “routine experimentation.” (Id. at 3: ¶ 0040.) 6. Lastovich does not set forth a specific range of pressure values. 7. Connelly discloses a device for withdrawing or delivering a substance through a patient’s skin and includes a skin penetrating device with a plurality of skin penetrating members. (Connelly Abstract.) 8. Connelly describes that the skin penetrating device is positioned on a target site of a patient’s skin and “[p]ressure sufficient for the skin penetrating device to penetrate the skin” is provided. (Id. at 2:65- 67.) 9. Connelly specifically describes that the skin penetrated is the stratum corneum. (Id. at 3:59-64.) Appeal 2009-013144 Application 11/113,937 5 10. Rosenberg discloses a device for removing pus from a pimple and includes one end with a lancet and another with a pimple drain member. (Rosenberg Abstract.) 11. In Rosenberg, the lancet operates to pierce a pimple formed in a patient’s skin. (Id. at 4:25-34.) D. PRINCIPLES OF LAW Anticipation is established only when a single prior art reference discloses all elements of the claimed invention. In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990). Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456 (CCPA 1955). It is not necessary that the inventions of the references be physically combinable, without change, to render obvious the invention under review. In re Sneed, 710 F.2d 1544, 1550 (Fed. Cir. 1983). The test for obviousness is what the combined teachings of the references would have suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413, 425 (CCPA 1981). E. ANALYSIS The Anticipation Rejection The Examiner rejected claims 19 and 21-24 as anticipated by Lastovich. Claims 21-24 are dependent on, and argued collectively with, independent claim 19. We focus on the limitations that are in dispute. Claim 19 is drawn to a device that includes a plurality of microprotrusions Appeal 2009-013144 Application 11/113,937 6 for contacting and piercing a patient’s skin and which “provides an impact pressure when applied to said skin of from about 0.5 lbs/cm2 to about 7 lbs/cm2.” (App. Br. 10 Claims App’x.) J & J contends that Lastovich does not disclose a device that provides that specific range of impact pressure, i.e., about 0.5 lbs/cm2 to about 7 lbs/cm2. Lastovich discloses an abrader device that delivers a substance into the skin by pressing the device against the skin. (Lastovich Abstract.) The Examiner does not disagree with J & J that Lastovich does not describe the application of a particular pressure value that falls within the range of impact pressures specified in the claims. According to the Examiner, however, the requirement that the device “provides” the specified impact pressure is met by a device that is simply capable of providing that pressure. The Examiner concludes that Lastovich’s device is capable of supplying the required impact pressure and meets the requirement of claim 19. (Ans. 10:4-7.) We reject the Examiner’s position as it is based on an incorrect interpretation of the claim recitation that it is the device that provides the specified impact pressure. J & J’s specification describes embodiments in which the device is configured to include components, such as springs or other potential energy storage devices, that provide the pressure necessary to pierce the skin. (E.g., Spec. pp. 23-26 and pp. 30-33.) In the context of J & J’s specification, the claim requirement that the device provides certain impact pressure means the device itself is suitably set and configured to output the necessary level of impact pressure. The Examiner does not point to any portion of Lastovich establishing that its device is already configured to supply an impact pressure within the specified range. Neither does the Examiner find that such a setting is inherent to Lastovich’s device. That Appeal 2009-013144 Application 11/113,937 7 Lastovich’s abrader device may possibly be configured and arranged to output a necessary pressure level is not enough to meet the claimed limitation of J & J’s claim 19. We do not sustain the rejection of claim 19 as anticipated by Lastovich. We also do not sustain the rejection of dependent claims 21-24, which include all the features of claim 19, as anticipated by Lastovich. The Obviousness Rejections The Examiner rejected each of claims 1-18 and 20 as obvious in view of the prior art. Specifically, the Examiner rejected the claims as follows: (1) claims 1-3, 8, and 9 as unpatentable over Skover and Lastovich; (2) claims 4-7 as unpatentable over Skover, Lastovich, and Cormier; (3) claims 10-16 and 18 as unpatentable over Rosenberg and Connelly; (4) claim 17 as unpatentable over Rosenberg, Connelly, and Lastovich; and (5) claim 20 as unpatentable over Lastovich and Cormier. The rejections of claims 1-9 Claims 1-3, 8, and 9 were rejected based on the combined teachings of Skover and Lastovich. Claims 4-7 were rejected over those references along with Cormier. The patentability of claims 2-9 is not argued apart from that of claim 1. Claim 1 is drawn to a method of treating acne on skin and includes using a stratum corneum-piercing device that “provides an impact pressure when applied to said skin of from about 0.5 lbs/cm2 to about 7 lbs/cm2.” (App. Br. 8 Claims App’x.) J & J contends that neither Skover nor Lastovich discloses that an impact pressure in that range is provided. J & J also argues that its invention is not an obvious modification of the Appeal 2009-013144 Application 11/113,937 8 teachings of the references. In support of that argument, J & J states the following (App. Br. 5:8-11): Applicants have experimentally identified an optimum pressure range for use in their methods and device, so that they may be used on facial skin. As neither Skover nor Lastovich is concerned with facial skin (or skin on any other specific area of the body), they cannot teach this improvement. J & J’s argument is misplaced. The claims do not refer to “facial skin.” The claims refer only generally to “skin.” The record does not reflect that the specified impact pressure range appearing in the claims is “optimum” only for a specific area of skin, to the exclusion of any other area. The assertion is merely argument of counsel, which cannot take the place of evidence lacking in the record. Estee Lauder Inc. v. L'Oreal, S.A., 129 F.3d 588, 595 (Fed. Cir. 1997). In any event, the Examiner reasoned that in view of the teachings of Skover and Lastovich, a person of ordinary skill in the art would have recognized that the impact pressure applied to skin for stratum corneum piercing devices is a result effective variable and would have optimized the impact pressure to values within the range called for in J & J’s claims. (Ans. 10:18-11:3.) That reasoning is sound. Skover generally discloses a method of treating skin (Skover Abstract), which includes creating an opening in the stratum corneum. (Id. at 2: ¶ 0019.) Lastovich discloses an abrader device for abrading and penetrating the stratum corneum of skin. (Lastovich 3: ¶ 0037.) Lastovich describes that the amount of pressure supplied by the device “may be controlled to provide optimum reproducible abrasion of the desired area of the skin.” (Id. at 2: ¶ 0015.) Lastovich also specifies that the amount of Appeal 2009-013144 Application 11/113,937 9 pressure is selected so as to sufficiently penetrate the stratum corneum while not so great to as to penetrate other epidermal layers of skin. (Id. at 6: ¶ 0066.) Lastly, Lastovich describes that the appropriate pressure provided is determined as a matter of “routine experimentation.” (Id. at 3: ¶ 0040.) Thus, a person of ordinary skill in the art would have recognized that the teachings of the prior art, and in particular those of Lastovich, apply to the penetration of any “desired area of skin,” e.g., facial skin. Furthermore, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d at 456. The teachings of Lastovich reflect that a person of ordinary skill in the art would have determined through routine experimentation the impact pressures which are suitable for the penetration of the stratum corneum. We reject J & J’s argument that it would not have been obvious to optimize the impact pressure to a value within the range specified in J & J’s claims. That argument does not adequately account for the ability of one of ordinary skill in the art in following the teachings of Lastovich with respect to determining an appropriate impact pressure for penetrating a patient’s skin. We sustain the rejection of claim 1 over Skover and Lastovich. Because claims 2-9 are not separately argued apart from claim 1, we also sustain the rejection of claims 2, 3, 8, and 9 over Skover and Lastovich, and the rejection of claims 4-7 over Skover, Lastovich, and Cormier. The rejections of claims 10-18 The Examiner rejected claims 10-16 and 18 over Rosenberg and Connelly, and claim 17 over Rosenberg, Connelly, and Lastovich. J & J argues dependent claims 11-18 collectively with independent claim 10. Appeal 2009-013144 Application 11/113,937 10 Claim 10 is drawn to a method of removing pus from a pimple and includes a device that “provides an impact pressure when applied to said skin of from about 0.5 lbs/cm2 to about 7 lbs/cm2.” (App. Br. 9 Claims App’x.) J & J contends that neither Rosenberg nor Connelly, taken singly or in combination, describe the use of an impact pressure within that stated range. According to J & J, each of the references is “completely silent about pressure.” (Id. at 6:8; 6:12.) Rosenberg discloses a device for removing pus from a pimple and includes one end with a lancet and another with a pimple drain member. (Rosenberg Abstract.) The lancet operates to pierce a pimple formed in a patient’s skin. (Id. at 4:25-34.) Connelly discloses a device for withdrawing or delivering a substance through a patient’s skin and includes a skin penetrating device with a plurality of skin penetrating members. (Connelly Abstract.) Connelly describes that the skin penetrating device is positioned on a target site of a patient’s skin and “[p]ressure sufficient for the skin penetrating device to penetrate the skin” is provided. (Id. at 2:65-67.) The Examiner explained that in light of the teachings of those references, a person of ordinary skill in the art would have recognized that the impact pressure to penetrate a patient’s skin is a result effective variable and would have known to optimize that variable by selecting an impact pressure that is within the range set forth in J & J’s claims. (Ans. 11:20-21:1.) The Examiner’s explanation is reasonable. J & J’s assertion that each reference, including Connelly, is “silent about pressure” is inaccurate and does not account for Connelly’s disclosure of supplying a “sufficient” pressure to penetrate skin. J & J does not meaningfully explain why impact pressures falling within the range “about 0.5 lbs/cm2 to about 7 lbs/cm2” are Appeal 2009-013144 Application 11/113,937 11 outside of the known pressures values that a person of ordinary skill in the art would have readily appreciated as sufficient for skin penetration. J & J also argues that the teachings of Rosenberg and Connelly are not combinable because the references “approach withdrawing substances from the skin in two different ways.” (App. Br. 6:20-22.) According to J & J (Id. at 6:22-27): Rosenberg uses separate tools to cut and then withdraw a substance from the skin in sequence, using the one end and then the other end of the device. Connelly is designed to cut the skin and withdraw a substance at the same time through a single location. The devices cannot be combined without changing their essential structures and operating them in ways contrary to what each references teaches. J & J’s argument is misplaced. It is not necessary that the inventions of the references be physically combinable, without change, to render obvious the invention under review. In re Sneed, 710 F.2d 1544, 1550 (Fed. Cir. 1983). Rather, the test for obviousness is what the combined teachings of the references would have suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413, 425 (CCPA 1981). Here, each of Rosenberg and Connelly describe devices that operate to penetrate skin. Connelly teaches that the amount of pressure necessary for skin penetration must be “sufficient.” That the particular configurations of the two devices are not identical to one another or may not be immediately implementable onto one another, without change or adjustment, does not mean that their teachings can not be combined. The level of ordinary skill in the art is such that one with ordinary skill would have appreciated from the combined teachings of the references that there are a number of known configurations for skin penetrating devices and that those Appeal 2009-013144 Application 11/113,937 12 devices operate to pierce skin upon application of a range of impact pressures. A person of ordinary skill in the art would have readily recognized that the teachings of Rosenberg and Connelly may be combined and that they adequately account for the features of claim 10. For the foregoing reasons, we sustain the rejection of claim 10. We also sustain the rejection of claims 11-16 over Rosenberg and Connelly and claim 17 over Rosenberg, Connelly, and Lastovich. The rejection of claim 20 Claim 20 is dependent on claim 19. Claim 19 recites (App. Br. 10 Claims App’x.):2 A device comprising (i) a microprotrusion member having a skin-contacting surface and plurality of stratum corneum-piercing microprotrusions thereon and (ii) a composition comprising an anti-acne agent, wherein said device provides an impact pressure when applied to said skin of from about 0.5 lbs/cm2 to about 7 lbs/cm2. Claim 20 adds features specifying that the composition is “coated” onto portions of the device including the stratum-corneum piercing microprotrusions. The Examiner rejected claim 20 as unpatentable over Lastovich and Cormier. The Examiner determined that Lastovich accounts for all the limitation of claim 20 with the exception of microprotrusions that are coated. To make-up for the deficiency the Examiner pointed to Cormier as teaching 2 Claim 19 has been reproduced with indentations in accordance with 37 C.F.R. § 1.75(i). Appeal 2009-013144 Application 11/113,937 13 the coating of a stratum corneum piercing member 10 with a therapeutic agent. (Ans. 9:1-4.) J & J challenges the Examiner’s rejection, stating the following (App. Br. 7:15-16). Cormier does not teach or suggest a device for use on the face or to treat acne. Applicants maintain this combination does not arrive at the claimed invention. J & J, however, does not explain the significance of those statements. Neither claim 20 nor claim 19 refer to a “face.” Nor does either claim refer to treating acne. Claim 19 does refer to its composition as being an “anti- acne agent.” However, each of Lastovich and Cormier disclose that a variety of “pharmaceutical agents” may be delivered to the skin of a patient. (Lastovich 3: ¶ 00036; Connelly 4:1-15.) J & J does not explain why a person of ordinary skill in the art would not have appreciated that the pharmaceutical agents described in those references can include anti-acne agents, or that one with ordinary skill would not have recognized acne as a skin condition treatable by a pharmaceutical agent. We sustain the rejection of claim 20 as unpatentable over Lastovich and Cormier. New Ground of Rejection Pursuant to 37 C.F.R. § 41.50(b), the following new ground of rejection is applied to J & J’s claim 19. Claim 19 is rejected under 35 U.S.C. § 103(a) as unpatentable over Lastovich and Cormier. Because claim 20 is unpatentable over the combination of Lastovich and Cormier, the broader claim 19, all of whose features are included in Appeal 2009-013144 Application 11/113,937 14 claim 20, is also unpatentable over Lastovich and Cormier. See Ormco Corp. v. Align Tech., Inc., 498 F.3d 1307, 1319-20 (Fed. Cir. 2007); In re Muchmore, 433 F.2d 824, 825 (CCPA 1970). F. CONCLUSION 1. J & J has shown that the Examiner was incorrect in finding that Lastovich anticipates a devices that provides an impact pressure to skin of from about 0.5 lbs/cm2 to about 7 lbs/cm2. 2. J & J has not shown that the Examiner erred in concluding that a person of ordinary skill in the art would have concluded that providing an impact pressure of 0.5 lbs/cm2 to about 7 lbs/cm2 would have been obvious based on the teachings of the prior art. 3. J & J has not shown that the Examiner erred in determining that a person of ordinary skill in the art would have recognized that the teachings of Rosenberg and Connelly may be combined. 4. J & J has not shown that the Examiner erred in determining that claim 20 is obvious in light of the teachings of Lastovich and Cormier. G. ORDER The rejection of claims 19 and 21-24 under 35 U.S.C. § 102(b) as anticipated by Lastovich is reversed. The rejection of claims 1-3, 8, and 9 under 35 U.S.C. § 103(a) as unpatentable over Skover and Lastovich is affirmed. The rejection of claims 4-7 under 35 U.S.C. § 103(a) as unpatentable over Skover, Lastovich, and Cormier is affirmed. The rejection of claims 10-16 and 18 under 35 U.S.C. § 103(a) as unpatentable over Rosenberg and Connelly is affirmed. Appeal 2009-013144 Application 11/113,937 15 The rejection of claim 17 under 35 U.S.C. § 103(a) as unpatentable over Rosenberg, Connelly, and Lastovich is affirmed. The rejection of claim 20 under 35 U.S.C. § 103(a) as unpatentable over Lastovich and Cormier is affirmed. This decision contains a new ground of rejection pursuant to 37 C.F.R. § 41.50(b). That section provides that the Appellant, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the proceeding will be remanded to the examiner…. (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same record…. AFFIRMED-IN-PART rvb PHILLIP S. JOHNSON JOHNSON & JOHNSON ONE JOHNSON & JOHNSON PLAZA NEW BRUNSWICK, NJ 08933-7003 Copy with citationCopy as parenthetical citation