Ex Parte Kjellin

Patent Trial and Appeal BoardOct 25, 2017

12744773 (P.T.A.B. Oct. 25, 2017)

UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 12/744,773 05/26/2010 Per Kjellin 9737-4/2204.04 5100 20792 7590 10/25/2017 MYERS BIGEL, P.A. PO BOX 37428 RALEIGH, NC 27627 EXAMINER SHAH, SAMIR ART UNIT PAPER NUMBER 1787 MAIL DATE DELIVERY MODE 10/25/2017 PAPER Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte PER KJELLIN ____________ Appeal 2016-008375 Application 12/744,7731 Technology Center 1700 ____________ Before ADRIENE LEPIANE HANLON, DONNA M. PRAISS, and BRIAN D. RANGE, Administrative Patent Judges. PRAISS, Administrative Patent Judge. DECISION ON APPEAL2 Appellant seeks our review under 35 U.S.C. § 134(a) of the Examiner’s decision rejecting claims 10–21. We have jurisdiction over the appeal under 35 U.S.C. § 6(b). We REVERSE. 1 Appellant identifies the real party in interest as Promimic AB. App. Br. 2. 2 In this Decision we reference the Specification filed May 26, 2010 (“Spec.”), the Non-Final Office Action dated June 30, 2015 (“Non-Final Act.”), the Appeal Brief filed Feb. 9, 2016 (“App. Br.”), Declaration Under 37 C.F.R. § 1.132 of Per Kjellin, Ph.D. dated May 28, 2013 (“Kjellin Decl.”), the Examiner’s Answer dated July 13, 2016 (“Ans.”), and the Reply Brief filed Sept. 12, 2016 (“Reply Br.”). Appeal 2016-008375 Application 12/744,773 2 STATEMENT OF THE CASE Claims 10 and 21 are illustrative of the subject matter on appeal and are copied below from the Claims Appendix to the Appeal Brief (paragraphing added and disputed limitations italicized): 10. A calcium phosphate particle comprising a water-soluble amino acid, said water-soluble amino acid comprising at least two functional groups comprising a negatively charged group and a positively charged group, wherein said negatively charged group of said water-soluble amino acid is attached to said calcium phosphate particle, thereby providing a coated calcium phosphate particle, and said positively charged group of said water-soluble amino acid is attached to a solid support comprising an oxide surface or a polymer surface so that said water-soluble amino acid is simultaneously attached to said solid support and said calcium phosphate particle, thereby providing said coated calcium phosphate particle in the form of a coating on said solid support. 21. A calcium phosphate particle comprising a water-soluble amino acid, wherein said water-soluble amino acid is monomeric and comprises at least two functional groups comprising a negatively charged group and a positively charged group, wherein said negatively charged group of said water-soluble amino acid is attached to said calcium phosphate particle, thereby providing a coated calcium phosphate particle, and wherein said positively charged group of said water-soluble amino acid is attached to a solid support comprising an oxide surface or a polymer surface, thereby providing said coated calcium phosphate particle in the form of a coating on said solid support. Appeal 2016-008375 Application 12/744,773 3 THE REJECTIONS3 1. Claims 10–21 stand rejected under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement; and 2. Claims 10–20 stand rejected under 35 U.S.C. § 102(b) as anticipated by Furedi-Milhofer.4 ANALYSIS Written Description The Examiner finds that “said water soluble amino acid is simultaneously attached to said solid support and said calcium phosphate particle” recited in claim 10 is not supported by the Specification. Non- Final Act. 2–3. The Examiner further finds that “water soluble amino acid is monomeric . . .” recited in claim 21 is not supported by the Specification. Id. at 3. Appellant contends that the Examiner’s written description rejections are in error because the two attachments to the amino acid are stated in original claim 10 itself and are described in the Specification to “reasonably convey[] that the water-soluble amino acid is simultaneously attached to both the solid support and the calcium phosphate particle.” App. Br. 3–4 (citing Spec. 5:4–19, 9:22–34, claim 10 as originally filed). Appellant also asserts that the disclosure in the Specification of amino acids such as neutral amino acids, basic amino acids, and acidic amino acids that may be organic 3 The rejection of claim 21 under 35 U.S.C. § 102(b) stands withdrawn. Ans. 2. 4 Furedi-Milhofer et al., US 2006/0216494 A1, pub. Sept. 28, 2006 (“Furedi- Milhofer”). Appeal 2016-008375 Application 12/744,773 4 compounds having a positively charged group and a negatively charged group, in addition to the exemplified amino acids lysine and aspartic acid which are monomeric, “clearly conveys that the amino acid can be monomeric.” Id. at 5 (citing Spec. 9:10–14, 9:22–29). The Examiner responds that there is no support for claim 10’s recitation “said water soluble amino acid is simultaneously attached to said solid support and said calcium phosphate particle” because “simultaneously” requires attachment of both the positively charged group and the negatively charged group at the same time. Ans. 3. According to the Examiner, the Specification only requires that the charged groups attach and the charged groups could have attached one following the other rather than at the same time. Id. Regarding “monomeric” recited in claim 21, the Examiner finds that the Specification broadly discloses amino acid, so the amino acid can be polymeric or monomeric. Id. In the Reply Brief, Appellant argues that the recited “simultaneously” does not add a method step to the claim, but, rather, is preceded by “so that” and thereafter reiterates the prior recitations regarding the amino acid being attached to both the solid support and the calcium phosphate particle. Reply Br. 4. Regarding “monomeric,” Appellant asserts that an amino acid is a monomer that can undergo polymerization to form a polyamino acid or peptide, and what remains after water is removed from the combination of amino acids is called an amino-acid residue. Id. at 2 (citing Exhibit A (International Union of Pure and Applied Chemistry (USPACC), http://goldbook.iupac.org/A00279.html, last accessed Sept. 16, 2014)). Appellant also points out that the Examiner concurs that an amino acid can Appeal 2016-008375 Application 12/744,773 5 be monomeric and that it is not disputed that lysine and aspartic acid are monomers. Id. (citing Spec. 9:10–14). “Adequate written description means that the applicant, in the specification, must ‘convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the [claimed] invention.’” Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1379 (Fed. Cir. 2009) (citation omitted). The pertinent inquiry is not whether the Specification provides a reason to have made the invention which is now claimed, but whether the invention, with all its claimed limitations, is described in it. See Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). We agree with Appellant that the Specification sufficiently supports the dual attachment of the amino acid to both the solid support and the calcium phosphate particle. The Examiner does not find otherwise in this regard. Ans. 2–3. We also agree with Appellant that the context of claim 10 itself reflects that the recited “simultaneously” is not a product-by-process limitation modifying the timing of the initial attachments, as the Examiner concludes, but, rather, describes the structure of the final product subsequent to the two separate attachments recited earlier in the claim. The resulting structure with both attachments existing simultaneously “provide[s] said coated calcium phosphate particle in the form of a coating on said solid support” as subsequently recited in claim 10. Therefore, the broadest reasonable interpretation of claim 10 is that the recited attachments are present simultaneously in the claimed calcium phosphate particle and this interpretation is supported by the Specification. Accordingly, we reverse the Examiner’s rejection of claims 10–20 on this basis. Appeal 2016-008375 Application 12/744,773 6 Regarding “monomeric” recited in claim 21 to describe the amino acid, we agree with Appellant that the Specification discloses both the genus of amino acids (neutral amino acids, basic amino acids, and acidic amino acids) as well as two specific species of amino acids (lysine and aspartic acid). Spec. 9:10–14. There is no dispute that the species lysine and aspartic acid are monomers. The Examiner’s finding that amino acids are broadly understood to be polymeric or monomeric (Ans. 3) is consistent with the Specification’s broad disclosure of all forms of “amino acids” as well as Appellant’s position that “the [S]pecification clearly conveys that the amino acid can be monomeric” (App. Br. 5) (emphasis added). Appellant’s subsequent assertion in the Reply Brief that a skilled artisan would “recognize an amino acid is a monomer and this monomer can undergo polymerization to form a polyamino acid or peptide” (Reply Br. 2) is not directly supported by the definition of “amino acid residue” submitted by Appellant as Exhibit A. Appellant infers from the “amino acid residue” definition, i.e., “[w]hen two or more amino acids combine to form a peptide . . . ”, that (1) amino acids cease to be amino acids upon polymerization to form a polyamino acid or (2) amino acids are monomers because they are building blocks of polyamino acids. Reply Br. 2. Based on the cited record in this appeal, we are not persuaded that amino acids are categorically monomeric. Amino acid is defined in at least one source as “any of a class of organic compounds that contains at least one amino group, –NH 2 , and one carboxyl group, –COOH: the alpha-amino acids, RCH(NH 2)COOH, are the building blocks from which proteins are constructed.” See Dictionary.com, http://www.dictionary.com/browse/amino-acid?s=t, last visited Oct. 12, 2017. Nevertheless, it is not disputed that amino acids can Appeal 2016-008375 Application 12/744,773 7 be monomers and that two monomeric amino acids are exemplified in the Specification. Whether the exemplified monomeric amino acids named in the Specification among the broader disclosure of neutral, acidic, or basic amino acids generally, which can be monomeric or polymeric, is adequate to convey with reasonable clarity that Appellant was in possession of the claimed monomeric amino acid is the question before us. We answer this question in the affirmative. Appellant’s disclosure is clearly directed to amino acids of the type claimed, i.e., monomeric amino acids, given the specific examples of a basic amino acid and an acidic amino acid that are both monomeric. That the full scope of Appellant’s disclosure of amino acids in the Specification encompasses amino acids that can be polymeric does not negate Appellant’s possession of monomeric amino acids, particularly in view of the examples provided being all monomeric amino acids. “It is for the inventor to decide what bounds of protection he will seek.” In re Johnson, 558 F.2d 1008, 1018 (CCPA 1977) (limited genus claimed found to be supported generically and by specific examples). Therefore, we are persuaded that the Specification provides ample basis for Appellant to claim the limited genus of monomeric amino acids and reverse the rejection of claim 21. In sum, we reverse the rejection of claims 10–21 under 35 U.S.C. § 112, first paragraph. Anticipation We need to address only independent claim 10 because each of claims 11–20 depends directly or indirectly from claim 10. Appeal 2016-008375 Application 12/744,773 8 The Examiner finds that Furedi-Milhofer discloses coated calcium phosphate particles in the form of a coating on a polymer surface where the amino acid is polyaspartic acid and finds that polyaspartic acid is water soluble, has a positively charged amine group, and has a negatively charged –COOH group. Non-Final Act. 3–4. The Examiner further finds that given aspartic acid is the same as disclosed in the Specification, it would inherently function as claimed. Id. at 4. Appellant contends that polyaspartic acid is a polymer rather than an amino acid, it has a distinctly different structure than an amino acid, and that it can have distinctly different properties than an amino acid due to the side chains of each residue (-CH2COOH). App. Br. 7– 8. Appellant asserts that the Examiner failed to establish that the polyaspartic acid of Furedi-Milhofer would necessarily be arranged as claimed, i.e., with a negatively charged group attached to a calcium phosphate particle and a positively charged group attached to a solid support, because it is significantly larger and has significantly more charged groups compared to an amino acid. Id. at 8. Appellant further argues that the multi-layer structure of Furedi-Milhofer means that the first layer is attached to the substrate surface via a positively charged group of the polyelectrolyte and it is likely that the first layer would not be simultaneously attached to the amorphous calcium phosphate particles due to the multiple layers between the substrate surface and the particles. Id. at 9–10 (citing Kjellin Decl. ¶¶ 6–7). Appellant also argues that polyelectrolytes including polyaspartic acid of Furedi-Milhofer are unsuitable for binding both to a surface and a calcium phosphate particle because it is strongly negative and is used Appeal 2016-008375 Application 12/744,773 9 as a scale inhibitor to prevent deposits or precipitation of calcium phosphate particles on a surface. Id. at 10–11 (citing Kjellin Decl. ¶ 11). The Examiner responds that nothing in the claim excludes polyaspartic acid as the claimed amino acid given that it is made of the amino acid aspartic acid, has CH2COOH groups to attach to the calcium carbonate as claimed, and is also water soluble. Ans. 4. The Examiner also finds that there is nothing in the claim that excludes the structure of polyaspartic acid or its molecular weight. Id. Regarding Appellant’s strongly negatively charged polyaspartic acid argument, the Examiner finds that the Kjellin Declaration is conclusory and based on the position that Furedi-Milhofer requires multiple layers of electrolytes when the reference states “at least one” reflecting a single polyelectrolyte film is also disclosed. Id. at 5. The Examiner further finds that because polyaspartic acid is identical to the amino acid claimed, the claimed amino acid also would have a strong negative charge. Id. at 6. The Examiner acknowledges that Furedi-Milhofer does not explicitly disclose that the negatively charged group of the amino acid attaches to the calcium phosphate particle and the positively charged group of the amino acid attaches to the support, but finds that it would inherently function as claimed because the same water-soluble amino acid is used. Id. The Examiner further finds that the claim only requires one positively charged group and one negatively charged group and that the negatively charged layer would necessarily attach to calcium phosphate and the positively charged layer attach to the Appeal 2016-008375 Application 12/744,773 10 support because it is the same amino acid as claimed. Id. at 7. Regarding the suitability of polyaspartic acid to coat calcium phosphate particles, the Examiner finds that the reference itself discloses “depositing calcium phosphate on polyelectrolyte layer.” Id. In the Reply Brief, Appellant argues that a polyamino acid is not an amino acid, but rather a peptide or a polymer formed from two or more amino acids. Reply Br. 3. Appellant further argues that the negatively charged group of the water-soluble amino acid attached to the calcium phosphate particle and the positively charged group attached to the support as claimed would not necessarily occur in a polyamino acid for at least the reason that at least one end of each amino acid residue in the polyamino acid would be joined to another amino acid residue by a covalent, peptide bond. Id. Based on the cited record on appeal, we are persuaded of reversible error in the rejection of claim 10 as anticipated by Furedi- Milhofer. The Examiner acknowledges that Furedi-Milhofer does not disclose attachment of the negatively charged group of the amino acid to the calcium phosphate particle and the positively charged group to the support. Ans. 6. The Examiner does not adequately explain, however, why the polyamino acid form of aspartic acid disclosed by Furedi-Milhofer would inherently function to produce the claimed structure. Although the Examiner finds that Furedi-Milhofer discloses a single polyelectrolyte film comprising polyaspartic acid deposited on a surface (Non-Final Act. 3–4; Ans. 5–6; Furedi-Milhofer Abstr., ¶¶ 11, 13, claim 16) in addition to calcium phosphate particles in the form of a coating (Non-Final Act. 3; Furedi-Milhofer Abstr., ¶ 11), Appeal 2016-008375 Application 12/744,773 11 the structure defined by the claim of the amino acid being attached at the negatively-charged group to the calcium phosphate particle while the positively-charged group is attached to the support is not necessarily formed by Furedi-Milhofer’s coating. Appellant contends that Furedi-Milhofer’s structure would be influenced by the strongly negative charge of polyaspartic acid making it unsuitable for both binding to a surface and a calcium phosphate particle. App. Br. 10–11 (citing Kjellin Decl. ¶ 11). We find Appellant’s evidence that Furedi-Milhofer’s polyamino acid would be strongly positively or negatively charged persuasive of a structural difference between the cited prior art calcium phosphate particle and the claimed calcium phosphate particle. Indeed, Furedi- Milhofer describes the coating layers being prepared by adsorption or embedding amorphous calcium phosphate particles into the polyamino acid film (Non-Final Act. 4; Furedi-Milhofer Abstr., ¶¶ 11, 33) which does not suggest the particular attachment structure claimed. We agree with Appellant (App. Br. 10) that claim 10 does not encompass attachment of a polyelectrolyte (polyamino acid) film to a substrate and to a calcium phosphate particle as taught by Furedi- Milhofer (where no single molecule is attached to both the substrate and to the calcium phosphate), but, rather, requires that a single polyelectrolyte (polyamino acid) be attached to both the particle and the support. The latter has not been sufficiently shown by the Examiner to support the rejection of claim 10 as anticipated by Furedi-Milhofer. Appeal 2016-008375 Application 12/744,773 12 Appellant has, therefore, persuasively argued the Examiner’s finding that Furedi-Milhofer discloses a polyelectrolyte coating that inherently functions as required by claim 10 is not supported by the record. Because we determine the facts and reasons relied on by the Examiner are insufficient to support anticipation of claim 10 by Furedi-Milhofer, we reverse the rejection of claim 10, as well as claims 11–20 which depend from claim 10 either directly or indirectly. DECISION Each rejection is reversed. ORDER REVERSED