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 .
Receipt is acknowledged of IDS filed on 12/19/2024.
Claims 1-22 and 24-26 are pending.
Claim 23 is cancelled.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1 and 4-18 are rejected under 35 U.S.C. 103 as being unpatentable over TIMM (US 2018/0228920).
Regarding claim 1, TIMM teaches a staining composition that is used for marking the gastrointestinal tissue (claim 30) comprising water (page 8, paragraph 0082), carbon particles (claim 1), that are derived from carbon black (claim 18), and a viscosity-increasing agent (claim 8), such as hyaluronic acid (page 7, paragraph 0070).
Regarding claim 11, TIMM teaches the composition further comprises glycerol (claim 10), Tween 80/polysorbate (page 2, paragraph 0016), and benzyl alcohol (claim 25).
Regarding claim 14, TIMM teaches the composition can be sterilized using an autoclave (page 1, paragraph 0008).
Regarding claim 15, TIMM teaches the composition does not comprise a dye (claims 1-25).
Regarding claim 16, TIMM teaches the composition further comprises glycerol (claim 10), which according to Applicant’s specification is a bulking agent (Applicant’s specification, page 4, paragraph 0031).
Regarding claim 17, TIMM teaches the composition can be in a syringe (page 9, paraph 0087).
Regarding claim 18, TIMM teaches a method of injecting the composition into a tissue using a syringe (page 9, paragraph 0087), such as gastrointestinal tissue (claim 30).
Additional disclosures: TIMM teaches carbon as a stain (claim 1), hyaluronic acid and glycerol as viscosity-increasing agents (claim 8), water as a base (page 8, paragraph 0082), Tween/polysorbate as a surfactant (page 2, paragraph 0016), which reduces or eliminates carbon particle agglomeration (page 3, paragraph 0037), and benzyl alcohol as a preservative (claim 25). The stain is used to mark an area of the gastrointestinal tract for surgical resection (page 4, paragraph 041).
Regarding claims 1, 4-10, 12-13, The reference does not specifically teach adding the components in the amounts/ratios claimed by Applicant. The amount/ratio of a specific component in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount/ratio of each component to add in order to best achieve the desired results, such as the appropriate amount of water and carbon to achieve the desired shade of black for clear marking, the appropriate amount of hyaluronic acid and glycerol for the desired viscosity to allow the ink to remain at the desired site longer, the appropriate amount of polysorbate to reduce or eliminate carbon particle agglomeration, and the appropriate amount of benzyl alcohol to achieve a long stable shelf life. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of component amounts/ratios would have been obvious at the time of Applicant's invention.
Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over TIMM (US 2018/0228920) in view of REBENDA (On the Dependence of Rheology of Hyaluronic Acid Solutions and Frictional Behavior of Articular Cartilage. Materials. 2020.).
TIMM teaches Applicant’s invention as discussed above.
TIMM does not teach the molecular weight of hyaluronic acid.
Regarding claim 2 and 3, REBENDA teaches that in hyaluronic acid injections, the molecular weight of the hyaluronic acid directly affects the viscosity of the injection (page 2, paragraph 3). The higher the molecular weight the higher the viscosity (page 2, paragraph 3). This type of relationship towards the concentration of hyaluronic acid in the solution is also present: higher concentration means higher viscosity (page 2, paragraph 3).
The reference does not specifically teach the molecular weight of the hyaluronic acid as claimed by the Applicant. The molecular weight of the hyaluronic acid is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of the ordinary skill to determine the optimal molecular weight of the hyaluronic acid in order to best achieve desired results, such as having the appropriate viscosity for the injection. For example, a low enough molecular weight/viscosity so that the solution can be easily injected through a syringe and a high enough molecular weight/viscosity that the solution will stay in the desired location of injection . Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the molecular weight of the hyaluronic acid would have been obvious at the time of Applicant’s invention.
Claims 1-22 and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over TIMM (US 2018/0228920) and REBENDA (On the Dependence of Rheology of Hyaluronic Acid Solutions and Frictional Behavior of Articular Cartilage. Materials. 2020.) in view of LUSIC (X‑ray-Computed Tomography Contrast Agents. Chemical Reviews. 2012.).
TIMM and REBENDA teach Applicant’s invention as discussed above. As discussed above, TIMM and REBENDA teach a composition comprising: water, carbon black, hyaluronic acid, and glycerol, which is a bulking agent.
TIMM and REBENDA do not teach adding a metal based polymer radiopaque component.
Regarding claim 19-22 and 24-25, LUSIC teaches imaging agents for X-Ray-computed tomography to visualize areas of interest in the gastrointestinal track (page 1641, paragraph 1). Metal based polymers can be used as contrast agents for X-Ray-computed tomography (page 1650, paragraph 7), which would be considered a radiopaque component.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a metal based polymer as a radiopaque material. The person of ordinary skill in the art would have been motivated to make those modifications, because it helps to visualize areas of interest in the gastrointestinal tract, and reasonably would have expected success because the references are in the same field of endeavor, such as visualizing the gastrointestinal tract.
Response to Arguments
Applicant argues, Hyaluronic acid is menti1`oned twice in Timm. Once in paragraph [0060] to describe how hyaluronic acid "should not be included in the composition if it is going to be sterilized by autoclaving." The second time is in paragraph [0070] as one option that can be included when there are multiple "viscosity-increasing agent". Applicant argues, Claim 14 depends on amended claim 1, which includes hyaluronic acid. Timm discloses in paragraph [0060] that hyaluronic acid "should not be included in the composition if it is going to be sterilized by autoclaving." Thus, Timm teaches away from amended claim 14.
Examiner does not find the argument persuasive because, TIMM discloses “non-crosslinked hyaluronic acid” should not be included in the composition if it is going to be sterilized by autoclaving (page 6, paragraph .0060). Then proceeds to state that hyaluronic acid can be used in a thermally stable composition and only explicitly states that carboxymethyl cellulose and hydroxypropyl methylcellulose should be sterilized in a non-thermal method (page 7, paragraph 0070). Therefor crosslinked hyaluronic acid could be used in the composition and the composition could be sterilized using an autoclave.
Applicant argues, the only viscosity-increasing agents that Timm discloses that can be used without another viscosity-increasing agent are glycerol, propylene glycol, isopropylene glycol, polyethylene glycol, and cellulose. (See Timm, [0014], [0069]-[0071], [0089], [0095], claims 8-10). Thus, there is nothing in Timm discloses how much hyaluronic acid may be present in Timm's composition, much less in relation to carbon black. Timm discloses that "carbon in the tissue staining composition can be from about 0.025% (w/v) to about 2.0% (w/v)" and that "viscosity increasing agent~ can be present in the staining composition at a final concentration of from about 5% to about 25%". (Timm, [0057], [0070]-[0071]). The resulting concentration mass of the viscosity-increasing agent(s) is between 2.5 and 1,000 times that of the carbon particles. Thus, Timm consistently teaches formulations in which the viscosity-increasing agent is present in substantially excess relative to the carbon particles.
Examiner does not find the argument persuasive because, obviousness does not require complete predictability and less preferred embodiments do not constitute a teaching away.
Furthermore, as discussed above, although the reference does not specifically teach adding the components in the amounts/ratios claimed by Applicant. The amount/ratio of a specific component in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount/ratio of each component to add in order to best achieve the desired results, such as the appropriate amount of water and carbon to achieve the desired shade of black for clear marking, the appropriate amount of hyaluronic acid and glycerol for the desired viscosity to allow the ink to remain at the desired site longer, the appropriate amount of polysorbate to reduce or eliminate carbon particle agglomeration, and the appropriate amount of benzyl alcohol to achieve a long stable shelf life. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of component amounts/ratios would have been obvious at the time of Applicant's invention.
Applicant argues, Timm is directed to carbon-based gastrointestinal tattoo compositions designed for optical endoscopic visualization. Timm focuses on suspension stability, particle size control, and injectability. Lusic, in contrast, is directed to radiographic contrast agents designed for X-ray or CT imaging. Lusic addresses systemic or organ imaging applications and does not concern submucosal tattoo marking. Moreover, incorporation of metal-based or high-density radiopaque agents into Timm's fine carbon suspension would materially alter the physical properties of the composition. Radiopaque metals significantly increase density and settling tendency, directly counter to Timm's teachings directed toward minimizing sedimentation. Lusic does not address stabilization of mixed-density particulate systems nor compatibility with carbon suspensions.
The Examiner finds Applicant’s argument unpersuasive, because in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this instance, as discussed in the rejection, it would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a metal based polymer as a radiopaque material. The person of ordinary skill in the art would have been motivated to make those modifications, because it helps to visualize areas of interest in the gastrointestinal tract, and reasonably would have expected success because the references are in the same field of endeavor, such as visualizing the gastrointestinal tract.
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.
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/S.L.M./ Examiner, Art Unit 1618
/Michael G. Hartley/ Supervisory Patent Examiner, Art Unit 1618