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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15-16 recites the limitation "claim 14". There is insufficient antecedent basis for this limitation in the claim. Claim 14 was previously cancelled.
Claims 20 recites the limitation "the isolated environmental humidity chamber” in the last paragraph of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claims 20 recites the limitation "the environmentally isolated chamber facility". There is insufficient antecedent basis for this limitation in the claim. In particular this is confusing because it is unclear if the claim is intended to say that the second chamber is separate from the first chamber or placed in a separate facility and in a separate chamber. For the purposes of this examination the examiner assumes that the applicant intends that the claim limitations to be read as though the first and second chambers are distinct but not necessarily in separate facilities.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 3-5, 7-13, 15-16 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Purdy et al. (USPGPub 2007/0027535) in view of Park et al. (WO2014/170870).
Regarding claims 1, 10, 14 and 20, Purdy teaches applying polymeric material in a liquid state to a valve frame and leaflet formation structure by dipping the structure in a polymeric solution and automatically moving the frame after taking it from the coating solution [0129-0135]. Purdy fails to teach wherein the coating takes places inside a chamber inside of a manufacturing facility. However, the examiner is taking Official Notice to inform the applicant that it is known in most coating fields to house coating operations and place them in facilities, especially those having volatile solvents to 1) prevent drying of coating compositions before use, 2) to prevent exposure of people and objects outside the coating area to volatilized solvent and 3) to prevent contamination of coating composition from outside sources. Therefore it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to house the operation of Purdy in both a chamber and a facility in order to gain the benefits stated above. Further although Purdy teaches that the drying may occur in a separate heating oven that is implicitly temperature controlled, Purdy fails to teach that humidity is controlled in the drying oven. However, Park shows that coating chambers and drying ovens employed in the coating of heart valve leaflets are preferably heat and humidity controlled (pp. 18-19) wherein those of ordinary skill in the art would readily recognize that the amount of humidity present in the drying chamber would directly affect the ability of the material drying inside the chamber to dry. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to perform the drying operations of Purdy in the oven of Park in order control the drying process of Purdy. Park does not teach that his humidity controlled drying oven comprises sensors of circuitry to detect and control humidity. However first and foremost the examiner believes that those of ordinary skill in the art would consider these elements to be implicit in Park especially given that without some sensor it would not seem possible to determine if the device of Park was within its intended range wherein a movement of humidity outside the desired range would prompt some action from the device to bring the humidity back within the set range and means to control this humidity would likely be electronic in nature and thus comprise circuitry. However, in an alternate the examiner is taking Official Notice to inform the applicant that sensors and circuitry are commonly provided means in a wide variety of devices to control desired levels. For example, heaters often have temperature sensors and means to adjust temperature. In home HVAC systems have humidifiers with humidistats to detect humidity and circuitry to cause the provision of moisture to the air. Electrical circuits may have surge detectors (sensors) to detect power surges and circuitry necessary to shut off the flow of electricity. This concept of sensor based action circuitry is common in most fields and one would use it in the device of Park if it were not already understood to be present as a simple application of a known sensing and response circuitry provided in a plurality of mechanical fields to a known device ready for improvement wherein the provisional of said improvement would be predictable based on its generalized use to those of ordinary skill in the art in a wide variety of machinery related fields. Further it is noted that leaflet coating of Purdy shows a level of thickness and percent variation that would correspond to the thickness variation of the current claims [0050]. Further Purdy generally teaches rotating the device being dried during drying [0161]. The teachings of Purdy in view of Park are as shown above. Purdy in view of Park fails to teach the use of a third chamber to which the device being treated is moved after partial curing of the device in the first drying oven. However, this would constitute a mere separation of the steps of Purdy from one drying step into two wherein the second humidity chamber of the current claims is not defined as being different in any way from the first. As such the Court has long held that in general, the transposition of process steps or the splitting of one step into two, wherein the processes are substantially identical or equivalent in terms of function, manner and result is held to not patentably distinguish the processes. See Ex parte Rubin, 128 USPQ 440 (Bd. Pat. App. 1959). See also In reBurhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946). Further the heating and drying of Purdy occur over a set period of time [0121].
Regarding claim 3, the rotation of Purdy as stated above would necessarily take place “around the environmental humidity chamber” and rotation would generally be understood to take place about some axis.
Regarding claim 4, based on the drying times taught [0171] and the rotation rates or Purdy [0131] and a lack of necessarily need to change the direction of rotation, it can be stated that in at least some embodiments the frame of Purdy would be understood to rotate at least one time.
Regarding claim 5, the teachings of Purdy in view of Park are as shown above. Purdy in view of Park fails to necessarily that the humidity control comprises access to a liquid. However, first it is the position of the examiner that one of ordinary skill in the art would view this as reasonably implied. It would be difficult to increase humidity (i.e., control humidity above a low level which Park seems to be able to do) with access to a humidity creating medium. Second in a case wherein this is not implicit, the examiner is taking Official Notice to inform the applicant that the use of water or a liquid medium is a common way of increasing humidity in general. Humidity is added to home HVAC using water lines to control humidity as is also done with steam ovens and steam autoclaves. Use of a moisture source to control humidity is well established in industrial manufacture in general. Therefore if it were not already understood to be present in the invention of Purdy in view of Park it would have been considered obvious by those of ordinary skill in the art at the time of invention to use a liquid medium as a source of humidity for humidity control in the invention of Purdy in view of Park as a simple application of a known humidity source to a known humidity providing device ready for improvement wherein the provisional of said improvement would be predictable based on its generalized use to those of ordinary skill in the art in a wide variety of machinery related fields.
Regarding claims 7 and 12, the teachings of Purdy in view of Park are as shown above. Purdy in view of Park fails to teach the size of the chamber. However, the chamber of Purdy would reasonably have some size and the Court has long held that in the absence of a criticality of a claimed change in size from an original size of a claimed object, a change is size and shape cannot overcome a prima facie case of obviousness based on a prior art size. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Further one would generally be motivated to create a chamber that was as small as reasonably possible in order to conserve space in a coating area.
Regarding claim 8, there is no mention of a fan in the operation of Purdy.
Regarding claims 9 and 15, Purdy further teaches trimming excess from the frame that was coated but generally prior to crosslinking [0169][0093]. Purdy in view of Park fails to teach trimming after removal from the environmental humidity chamber (i.e., after drying). However, this would constitute a mere change in the order of the steps of Purdy in view of Park wherein the trimming step would be transposed to a time after the drying occurs wherein the Court has long held that in general, the transposition of process steps or the splitting of one step into two, wherein the processes are substantially identical or equivalent in terms of function, manner and result is held to not patentably distinguish the processes. See Ex parte Rubin, 128 USPQ 440 (Bd. Pat. App. 1959). See also In reBurhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results).
Regarding claim 11, the teachings of Purdy in view of Park are as shown above. Park fails to teach humidity control within the range claimed. However, Park teaches humidity control within the range claimed (as cited above as relates to drying conditions) for drying coating present on heart valves. 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 humidity level of Park for drying the coated valves of Purdy because Park shows that his humidity level is suitable for the intended purposes of Purdy (i.e. drying coated biomedical valves). See Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). See also Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Further in general, without citation of humidity levels for drying in Purdy, one applying the teachings of Park would likely use the conditions provided by Park as they are the only suitable conditions shown. Park is generally silent as to how tightly within the range that they humidity is controlled. However, in the cited portion Park generally does teach progressively more tightly controlled ranges to be more or most preferable. As such, Park seemingly recognizes that narrower control is more desirable, likely for consistency among other things. As such, it can be generally acknowledged that Park recognizes a desire to limit control even within a range that is desirable. Therefore, in the absence of criticality of the specific level of humidity control within the level of humidity control of the current claims (i.e., +-1% within the 50-90% range) it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the level of humidity as tightly as possible even within a range in order to produce a more consistent and uniform product logically.
Regarding claim 13, any part of the frame could be considered to be an “optical identifier”.
Regarding claim 16, the thicknesses provided by Purdy read on the claimed range.
Regarding claim 19, Purdy teaches wherein the range of thickness variation is within the claimed range [0045].
Response to Arguments
Although the primary art reference being applied is the same as in the last Office Action, all claims are rejected under a combination of prior art references not previously applied, wherein the applicants’ arguments in general are drawn to what was provided for by a different secondary reference in the previous action or for the failure of the primary reference to provide for all claim limitations. Arguments drawn to the previously provided references are moot in view of new grounds of rejection and arguments drawn to Purdy for failing to teach all claim limitations present wherein the use of Purdy was provided in conjunction with additional references in a 103-type obviousness rejection have long been held by the Court as incapable of overcoming a prima facie case of obviousness based on the combination of references.
Conclusion
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
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