Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 11-12, 40, 43, 79 and 86 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mullick et al. (USPGPub2015/0025198).
Regarding claims 1, 40, 43 and 79, Mullick teaches admixing a macromolecule that reads on the SMM formulas (claim 1) that is mixed with a base polymer (claim 73). Further it is noted that the SMM and base polymer are employed in similar percentages to those claimed in current claim 79. As such, the prior art composition would logically function in the manner claimed. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112. Furthermore, each claim must include all elements which applicant has described as essential. See, e.g., Johnson Worldwide Assoc. Inc. v. Zebco Corp., 175 F.3d at 993, 50 USPQ2d at 1613; MPEP 2163, Section II, Subsection A, Subsection 3, Subsection (b).
Regarding claims 11, Mullick teaches admixing a macromolecule that reads on the SMM formulas (claim 1) that is mixed with a base polymer (claim 73). Further it is noted that the SMM and base polymer are employed in similar percentages to those claimed in current claim 79. As such, the prior art composition would logically function in the manner claimed. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112. Furthermore, each claim must include all elements which applicant has described as essential. See, e.g., Johnson Worldwide Assoc. Inc. v. Zebco Corp., 175 F.3d at 993, 50 USPQ2d at 1613; MPEP 2163, Section II, Subsection A, Subsection 3, Subsection (b).
Regarding claims 12, Mullick teaches admixing a macromolecule that reads on the SMM formulas (claim 1) that is mixed with a base polymer (claim 73). Further it is noted that the SMM and base polymer are employed in similar percentages to those claimed in current claim 79. As such, the prior art composition would logically function in the manner claimed. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112. Furthermore, each claim must include all elements which applicant has described as essential. See, e.g., Johnson Worldwide Assoc. Inc. v. Zebco Corp., 175 F.3d at 993, 50 USPQ2d at 1613; MPEP 2163, Section II, Subsection A, Subsection 3, Subsection (b).
Regarding claim 86, Mullick additionally teaches testing outside (see Examples) wherein it is further noted that Mullick specifically teaches that the coating system provides is suited for use on articles intended to be used outside the body and implants used inside the body [0076-0079].
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Mullick et al. (2015/0025198) as applied to claims 1, 11-12, 40, 43, 79 and 86 above, and further in view of Estrand et al. (US8574604).
Regarding claim 10, the teachings of Mullick are as shown above. Mullick fails to teach contacting the implant surface with urine although it is noted that Mullick does teach wherein the implant may be a catheter. However, Estrand teaches that urinary catheters are a type of catheter and medical device (see col. 15, Shaped Articles) that are known to be coated with coating to those similar to the type of Mullick (see figures) and are combined with base polymers for controlling biological activity of the medical device. Therefore it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use the urinary catheter of Estrand as the medical device of Mullick as a use of a known coating technique to improve similar catheters in the same way. See KSR, 550 U.S. at 418, 82 USPQ2d at 1396.
Claims 14 and 28-29 is rejected under 35 U.S.C. 103 as being unpatentable over Mullick et al. (2015/0025198) as applied to claims 1, 11-12, 40, 43, 79 and 86 above, and further in view of Mullick et al. (WO2016/095042)(referred to herein as M2).
Regarding claim 14 the teachings of Mullick are as shown above. Mullick fails to teach contacting with his composition with agents as claimed. However, M2 teaches that it is known to provide compositions substantially similar to those of Mullick with monoclonal antibodies which are antimicrobial (pg. 11, lines 8-28). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide the coating system of Mullick with the monoclonal antibodies of M2 in order to provide the specific antimicrobial activity provided by monoclonal antibodies to the invention of Mullick.
Regarding claim 28 the teachings of Mullick are as shown above. Mullick to teach testing microbial activity in the timeframe claimed. However, M2 teaches using his coating system in conjunction with medical implants (see pg. 18, Medical Articles) and wherein the test periods implied for the use of the coating system of Mullick would read on the time frame claimed (see pg. 33, Measurement of Immobilization and/or Denaturation of a Biologic on the Surface). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to test the articles of Mullick using the testing timeframes and general methodologies of M2 as an application of a known testing technique applied to a known device ready for the improvements associated with providing additional testing data wherein the results of said testing would have been predictable based upon the overall similarity of the products of Mullick and M2.
Regarding claim 29 the teachings of Mullick are as shown above. Mullick to teach testing microbial activity in the timeframe claimed. However, M2 teaches using his coating system in conjunction with medical implants (see pg. 18, Medical Articles) and wherein the test periods implied for the use of the coating system of Mullick would read on the time frame claimed (see pg. 33, Measurement of Immobilization and/or Denaturation of a Biologic on the Surface). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to test the articles of Mullick using the testing timeframes and general methodologies of M2 as an application of a known testing technique applied to a known device ready for the improvements associated with providing additional testing data wherein the results of said testing would have been predictable based upon the overall similarity of the products of Mullick and M2. Further Mullick in view of M2 read upon performing the steps (i) and (ii) of the current claim simultaneously.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely primarily on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J BOWMAN whose telephone number is (571)270-5342. The examiner can normally be reached Mon-Sat 5:00AM-11:00AM.
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/ANDREW J BOWMAN/Examiner, Art Unit 1717
/ROBERT S WALTERS JR/Primary Examiner, Art Unit 1717