Ex Parte Sargeant et al

Patent Trial and Appeal BoardMay 21, 2018

13826561 (P.T.A.B. May. 21, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/826,561 03/14/2013 50855 7590 Covidien LP 60 Middletown A venue Mailstop 54, Legal Dept. North Haven, CT 06473 05/23/2018 FIRST NAMED INVENTOR Timothy Sargeant 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 ATTORNEY DOCKET NO. CONFIRMATION NO. H-US-03738 (203-9364) 6934 EXAMINER LOVE, TREVOR M ART UNIT PAPER NUMBER 1611 NOTIFICATION DATE DELIVERY MODE 05/23/2018 ELECTRONIC 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. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address( es): rs. patents. two@medtronic.com mail@cdfslaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte TIMOTHY SARGEANT and SAUMY A BANERJEE 1 Appeal2017-005874 Application 13/826,561 Technology Center 1600 Before ULRIKE W. JENKS, JOHN G. NEW, and RYAN H. FLAX, Administrative Patent Judges. FLAX, Administrative Patent Judge. DECISION ON APPEAL This is a decision under 35 U.S.C. Â§ 134(a) involving appealed claims directed to a therapeutic hydrogel. The Examiner's rejection of claims 2, 3, 7-10, and 21under35 U.S.C. Â§ 103(a) and for obviousness-type double patenting is appealed. We have jurisdiction under 35 U.S.C. Â§ 6(b). We affirm. 1 The Real Party in Interest is identified as "Covidien LP." Appeal Br. 1. Appeal2017-005874 Application 13/826,561 STATEMENT OF THE CASE The Specification states "[t]he present disclosure relates to hydrogels." Spec. i-f 1. Further, "[h]ydrogels are three-dimensional networks which swell in the presence of aqueous solutions. In a swollen state, hydrogels are soft and rubbery, resembling living tissue." Id. i-f 2. Further, "[h ]ydrogels may be utilized, for example, as a sealant for wounds, as a glue for adhering surgical implants to tissue, as drug delivery devices, as coatings on tissue and/ or medical devices, combinations thereof, and the like." Id. i-f 3. Independent claim 21, reproduced below, is representative: 21. A therapeutic hydrogel comprising: a first hydrogel precursor including gelatin; a second hydrogel precursor including a polyethylene glycol having 8 or more arms and n-hydroxysuccinimide groups thereon; and cells for delivery to a patient, wherein the first hydrogel precursor and the second hydrogel precursor react to form the therapeutic hydrogel, and wherein the therapeutic hydrogel has an osmolarity from about 200 mOsm/L to about 400 mOsm/L. Appeal Br. 11 (Claims App'x). 2 2 The Examiner noted: Acknowledgement is made to Applicant's election of: - gelatin as the first hydrogel precursor, - n-hydroxysuccinimide as the second hydrogel precursor, - chondrocytes as the cells, and - bioactive agents as the additional component. Final Action 2. When the examiner has required the applicant to elect single chemical species for examination, as is the case here, the issue on appeal is 2 Appeal2017-005874 Application 13/826,561 The following rejections are appealed: Claims 2, 3, 7-10, and 21 stand rejected under 35 U.S.C. Â§ 103(a) over Bennett3 and Fu. 4 Final Action 3. Claims 2, 3, 7-10, and 21 stand rejected on the ground ofnon- statutory double patenting over Sargeant5 and Fu. Id. at 7. DISCUSSION "[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting aprimafacie case ofunpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). We adopt the Examiner's findings of fact as set forth in the Final Action and Answer. Final Action 3-8; Answer 2-3. Obviousness "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). "[T]he analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and the patentability of the single elected species. It is appropriate to limit discussion to that single issue and take no position respecting the patentability of the broader generic claims, including the remaining, non- elected species. See Ex parte Ohs aka, 2 USPQ2d 1460 (BP AI 1987). 3 EP 2 233 161 A2 (pub. Sept. 29, 2010) ("Bennett"). 4 Yao Fu et al., 3D Cell Entrapment in Crosslinked Thiolated Gelatin- Poly(Ethylene Glycol) Diacrylate Hydrogels, 33(1) BIOMATERIALS 48-58 (2012) ("Fu"). 5 US 8,968,785 B2 (issued March 3, 2015) ("Sargeant"). 3 Appeal2017-005874 Application 13/826,561 creative steps that a person of ordinary skill in the art would employ." Id. at 418. "In determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid underÂ§ 103." Id. at 419. The Examiner determined the rejected claims would have been obvious over the Bennett-Fu combination; determining Bennett disclosed a hydro gel composition having the same components as claimed (e.g., gelatin and a multi-armed n-hydroxysuccinimide PEG), for drug delivery, and that Fu disclosed a similar hydrogel composition useful for chondrocyte (i.e., cells) encapsulation. Final Action 3-6 (citing Bennett in its entirety, but specifically i-fi-123, 27, 28, 70, 79, 80, 83; citing Fu in its entirety, but specifically at 2-3, 6, Figure 2); Answer 2-3. Based on the material and functional similarities between the hydro gels of Bennett and Fu, the Examiner determined that using the Bennett hydrogel for chondrocyte encapsulation, as taught by Fu, would have been obvious and that there would have been a reasonable expectation of successfully doing so. Final Action 4--5. As for the claimed osmolarity, the Examiner indicated that, while the specifically claimed osmolarity was not expressly disclosed by Bennett or Fu, because the hydro gel composition of Bennett was the same as that of the claim it would be expected to have the same osmolarity. Id. at 5 (citing In re Best, 562 F.2d 1252, 1255 (CCPA 1977) andin re Spada, 911 F.2d 705, 709 (Fed. Cir. 1990)). We discern no error in the Examiner's determinations. 4 Appeal2017-005874 Application 13/826,561 Appellants argue "nowhere does Bennett disclose the use of its hydrogels for the delivery of cells, such as chondrocytes." Appeal Br. 3. This argument is not persuasive. "Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references. . . . [The references] must be read, not in isolation, but for what [each] fairly teaches in combination with the prior art as a whole." In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). The Examiner cites Fu in combination with Bennett as teaching that chondrocytes can be delivered via hydrogels like those disclosed by Bennett. "[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill." KSR, 550 U.S. at 417. Thus, if chondrocytes are useful when paired with the gelatin/n- hydroxysuccinimide PEG hydro gel of Fu, they would also be obviously useful when paired with a similar gelatin/n-hydroxysuccinimide PEG hydrogel as disclosed in Bennett. Appellants argue "Bennett also fails to disclose or suggest its compositions have an osmolarity from about 200 mOsm/L to about 400 mOsm/L." Appeal Br. 4. This argument is not persuasive. Where ... the claimed and prior art products are identical or substantially identical ... the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. . . . [The] fairness [of the burden-shifting] is evidenced by the PTO' s 5 Appeal2017-005874 Application 13/826,561 inability to manufacture products or to obtain and compare prior art products. Best, 562 F.2d at 1255. The Examiner has determined that the compositions of the claimed invention and those of Bennett are the same hydro gels and, therefore, that their osmolarity would be expected to be the same. Appellants do not rebut this determination. Appellants argue that one of skill in the art would be led by Fu to a different hydrogel than the claimed invention because "Fu forms its thiolated gelatin by modifying gelatin with L-cysteine using n-hydroxysuccinimide polyethylene glycol as a linker (see Fu at Figure 2), Fu then reacts this material with polyethylene glycol diacrylate to form its hydrogel." Appeal Br. 4. This argument is not persuasive. The Examiner cites Fu not for its disclosure of a specific hydrogel composition or its fabrication, but because its hydro gel composition is similar to that of Bennett and also because Fu discloses that such a composition can be used to effectively deliver cells such as chondrocytes. See, e.g., Answer 2-3. Thus, whether or not Fu's hydrogel is identical to the claimed hydrogel is not determinative and, even if not, does not diminish the motivation to combine the references in the fashion discussed in the Final Action. For the reasons above, we affirm the obviousness rejection. Double Patenting The Examiner has determined that the rejected claims constitute unpatentable variants over the cited claims of Sargeant. Final Action 7; Answer 2. We discern no error in this determination. Appellants present no argument in rebuttal, but state "[u]pon obtaining a favorable decision from 6 Appeal2017-005874 Application 13/826,561 the Appeal Board as to the patentability of the claims, Appellant will submit a terminal disclaimer to overcome the double patenting rejection." Appeal Br. 6. Therefore, we affirm the rejection. SUMMARY The obviousness rejection is affirmed. The double patenting rejection is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a)(l)(iv). AFFIRMED 7