DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Status of the Claims
The response filed 12/29/2025 is acknowledged.
Claims 1-11 are pending.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Terminal Disclaimer
The terminal disclaimer filed on 12/29/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 18537704 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawn
The rejection of claim(s) 1-11 on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-10 of US 18537704 in view of Nishioka, WO 2013077357 A1 (cited on Applicant’s IDS dated 03/11/2024) in view of Ruane, 20220062498 A1 and Lee, US 20210393859 has been withdrawn because of the terminal disclaimer filed 12/29/2025.
Response to Arguments
Applicant's arguments filed 12/29/2025 have been fully considered but they are not persuasive.
Applicant has argued that since the mechanical challenge of maintaining a stable lifted site has no functional correlation or nexus with the electrical conductivity parameters discussed in Ruane, a person having ordinary skill in the art would have no motivation to further limit the conductivity of the composition disclosed in Nishioka based on the teachings of Ruane.
This argument is unpersuasive.
Nishioka teaches submucosal lifting compositions which contain water, a polymer, e.g., a polysaccharide, e.g., xanthan bum, locust bean gum, in an aqueous solution and having concentration ranging from 0.05 to 3.5% (Nishioka, e.g., claims, 0006, pg. 7, 0066), and osmotic pressure adjusters, e.g., glycerin, sorbitol, mannitol, xylitol, in an amount ranging from 0.1 to 6.0% (Nishioka, e.g., 0022, pp. 25-26). Nishioka’s compositions necessarily have an electrical conductivity since the electrical conductivity is a property of the composition. Nishioka does not characterize the electrical conductivity of their compositions.
Ruane provides clear motivation to optimize the electrical conductivity of submucosally injected lift compositions like those of Nishioka as enumerated in the previous Office action and reiterated below. Ruane teaches optimizing the electrical conductivity of submucosally injectable lifting compositions to prevent accidental perforation of the intestinal wall by transmission of electrosurgical energy (Ruane, e.g., 0006, 0010, and 0097). Ruane teaches reducing the conductivity of the composition as much as possible to prevent perforation of the intestinal wall during procedures using electrosurgical energy (Ruane, e.g., 0097) and prevent damage to the muscle layer of the intestine (Ruane, e.g., 0099). Ruane teaches compositions having a conductivity in the claimed range, e.g., 100-270 mS/m (Ruane, e.g., 0099, Table 8).
From Ruane, it is clear that the challenge of maintaining a stable lifted site was not the only challenge facing the skilled artisan trying to improve submucosal lift compositions like those of Nishioka before the effective filing date of the presently claimed invention. Accidental perforation by the transmission of electrosurgical energy was clearly a problem recognized by Ruane. Ruane provides a solution to this known problem by minimizing the conductivity of the composition.
Nishioka also recognizes the risk of perforation by electric scalpel or the like as a serious issue and recognizes the lifting effect of the submucosal injection as a means to mitigate the risk of perforation because the submucosal injection increases the physical distance between the lesion and the intestinal wall – protruding, protrusion, and prominence is the parlance for “lift” used in Nishioka. The submucosal material injection makes the lesion protrude from the intestinal wall and more prominent for the practitioner to further address (Nishioka, e.g., 0002).
Thus, in view of Ruane, the skilled artisan would have been motivated to test the electrical conductivity of Nishioka’s compositions, and even if the electrical conductivity of Nishioka’s compositions was outside the claimed range, the skilled artisan would have optimized the electrical conductivity parameter as needed to reduce the incidence of accidental perforation in the same way reported in Ruane.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Since Ruane is clearly concerned with improving submucosal lifting compositions and teaches solutions to problems associated with procedures requiring submucosal injection to lift the underlying mucosa for managing various diseases (Ruane, e.g. 0006-0020), Ruane was trying to solve the same problems as Nishioka.
Applicant argues the Proposed Combination Would Result in Technical Incompatibility and Lack of Reasonable Expectation of Success.
Applicant argues Nishioka employs polysaccharides (Please see paragraph [0006] of Nishioka), while Ruane employs acrylate (Please see the abstract of Ruane). Applicant argues these represent fundamentally different polymer chemical systems with distinct properties and behaviors, which would discourage a PHOSITA from combining them.
This argument is unpersuasive.
It is unclear why the skilled artisan would consider the polymer difference a barrier to optimizing the electrical conductivity. Nishioka teaches the polymer may be carrageenan which is an anionic polymer (Nishioka, e.g., 0009) like the acrylic acid used in Ruane. Similarly, xanthan gum is a polysaccharide which contains a carboxylic acid group from the glucuronic acid sugars in the backbone and Nishioka calls it a polysaccharide with a very strong negative charge due to the carboxyl groups in the side chain (Nishioka, e.g., 0008). Moreover, Ruane clearly teaches their compositions may contain a xanthan gum thickener in the same amount employed in Nishioka’s compositions (Ruane, e.g., 0068 and 0116). Nishioka notes xanthan gum’s properties as a thickener (Nishioka, e.g., 0013).
Applicant argues Nishioka discloses in paragraph [0068], Formulation Example 15, a composition containing 0.5% xanthan gum, 1.0% D-sorbitol, 0.45% sodium chloride, pH adjusting agent, and water. Applicant argues the viscosity of polysaccharide systems used in Nishioka (e.g., xanthan gum) is highly dependent on ionic concentration in the composition. Applicant argues that therefore, applying Ruane's low-conductivity requirement to Nishioka's system would necessarily require removal or significant reduction of ions from the composition. Applicant has argued reducing ionic concentration to achieve low electrical conductivity would create substantial technical uncertainty and would very likely compromise the viscosity characteristics upon which Nishioka's invention fundamentally relies. Applicant has argued a PHOSITA would recognize that such a reduction would likely compromise the viscosity recovery and lift- maintenance characteristics, thereby lacking a reasonable expectation of success.
This argument is unpersuasive.
Applicant has provided no evidence that modifying the conductivity of Nishioka’s compositions would require removal or significant reduction of ions from the composition. A significant reduction of ions may only be necessary if the electrical conductivity inherent to Nishioka’s composition deviated significantly from the range suggested by Ruane. Applicant has provided no evidence that Nishioka’s compositions exhibit an electrical conductivity which deviates significantly from the range suggested by Ruane as being effective to reduce the risk of perforation. Even if a substantial reduction of ions was required, Applicant has shown no evidence that the change would unavoidably result in a significant effect on viscosity. Ruane clearly teaches compositions similar to those of Nishioka which also contain negatively charged polymers, including, e.g., xanthan gum. If Ruane was able to optimize the electrical conductivity of compositions based on negatively charged polymers and maintain its effectiveness as a submucosal lifting composition for the intestinal wall, then it seems the skilled artisan would have likely been able to use the same techniques to modify Nishioka’s submucosal lifting composition for the intestinal wall which are also based on negatively charged polymers with a reasonable expectation of success and without compromising the viscosity and other desired properties. With respect to the ion concentration, it is noted that Nishioka teaches sugar alcohols, e.g., glycerin, sorbitol, mannitol, or xylitol may be used as an alternative for sodium chloride to achieve a desired osmotic pressure (Nishioka, e.g., 0022). Thus, if the skilled artisan needed to modify the amount of ions from salt, e.g., sodium chloride, to reduce electrical conductivity, the skilled artisan understood the amount salt removed may be substituted by a corresponding amount of non-ionic osmotic adjusting agent, e.g., sugars or sugar alcohols to maintain desired osmotic pressure. Further in this regard, Nishioka clearly points to the presence of the polysaccharide (Nishioka, e.g., 0006) and sugars or sugar alcohols as responsible for the desirable viscosity properties of the composition (Nishioka, e.g., 0007). Therefore, prior to the effective filing date of the presently claimed invention, the skilled artisan, reading Nishioka and Ruane, may have concluded the viscosity of Nishioka’s compositions does not appear to have a strong dependence on the ion content of the composition relative to the viscosity effect offered by the polysaccharide and sugar or sugar alcohols present.
Applicant has argued the additional teachings of Lee do not cure the fundamental deficiencies in the combined teachings of Nishioka and Ruane with respect to the subject matter of claim 1.
This argument is unpersuasive.
The alleged fundamental deficiencies in the combined teachings of Nishioka and Ruane is unpersuasive for the reasons discussed supra. Lee was cited for teaching propylene glycol and triethylene glycol were known alternatives for glycerin and may be used in combination with glycerin in compositions effective for mucosal lifting. See Lee, entire document, e.g., Abstract, 0012, 0021 and claims, e.g., claim 6. Thus, Lee cures any deficiency in the teachings of Nishioka and Ruane with respect to the subject matter of claim 3.
Claim Rejections - 35 USC § 103
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 of this title, 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.
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 1-2 and 4-11 are rejected under 35 U.S.C. 103 as being unpatentable over Nishioka, WO 2013077357 A1 (cited on Applicant’s IDS dated 03/11/2024) in view of Ruane, 20220062498 A1.
Nishioka teaches compositions for endoscopic submucosal injection (Nishioka, e.g., Title, 0001 bulking agent injected submucosally to elevate mucosal tissue, 0020 submucosal bulking agent). Compositions include water and a polysaccharide, e.g., xanthan bum, locust bean gum, in an aqueous solution and having concentration ranging from 0.05 to 3.5% (Nishioka, e.g., claims, 0006, pg. 7, 0066). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05. Compare instant claim 11.
Polymer molecular weights are in the claimed range, e.g., 800000, 1.5 million to 3 million (Nishioka, e.g., pg. 3), or 200000-300000 (Nishioka, e.g., 0010, pg. 13), or 310000 (Nishioka, e.g., 0011, pg. 15). See also, e.g., 0013, pg. 17. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05. compare instant claims 1-11.
Osmotic pressure ratios are in the claimed range. Nishioka teaches osmotic pressure ratios of, e.g., 1.05, 1.07, 0.99 (Nishioka, e.g., 0041, table 4). Osmotic pressure ratio of 1 is found in ¶ 0040. These are clearly disclosed values in the claimed range.
Compositions further comprise osmotic pressure adjusters, e.g., glycerin, sorbitol, mannitol, xylitol, in an amount ranging from 0.1 to 6.0% (Nishioka, e.g., 0022, pp. 25-26). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05. Compare instant claim 9. Glycerin, sorbitol, mannitol, and xylitol have molecular weights meeting the limitations of claims 1 and 5.
Nishioka does not expressly characterize the conductivity of the compositions. However, Ruane teaches the electrical conductivity of submucosal composition was recognized as a result effective parameter useful to prevent accidental perforation of the intestinal wall by transmission of electrosurgical energy (Ruane, e.g., 0006, 0010, and 0097). Ruane teaches reducing the conductivity of the composition as much as possible to prevent perforation of the intestinal wall during procedures using electrosurgical energy (Ruane, e.g., 0097) and prevent damage to the muscle layer of the intestine (Ruane, e.g., 0099). Ruane teaches compositions having a conductivity in the claimed range, e.g., 100-270 mS/m (Ruane, e.g., 0099, Table 8).
It would have been obvious before the effective filing date of the presently claimed invention to optimize the conductivity of compositions taught in Nishioka within the range of 100-270 mS/m as suggested by Ruane with a reasonable expectation of success. The skilled artisan would have been motivated to minimize or optimize the conductivity of the composition to achieve a composition which reduces the risk of damage to the muscle layer of the intestine and/or accidental intestinal wall perforation during electrosurgical procedures as reported in Ruane. The skilled artisan would have had a reasonable expectation of success because both documents teach compositions effective for mucosal lifting tissues including the intestines and stomach.
Accordingly, the subject matter of claims 1-2 and 4-11 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Nishioka, WO 2013077357 A1 (cited on Applicant’s IDS dated 03/11/2024) in view of Ruane, 20220062498 A1 as applied to claim 1-2 and 4-11 above, and further in view of Lee, US 20210393859.
The combined teachings of Nishioka and Ruane enumerated above teach a composition having the features required by claim 1 but do not expressly teach glycol compounds according to claim 3. However, Lee teaches propylene glycol and triethylene glycol were known alternatives for glycerin and may be used in combination with glycerin in compositions effective for mucosal lifting. See Lee, entire document, e.g., Abstract, 0012, 0021 and claims, e.g., claim 6.
It would have been obvious before the effective filing date of the presently claimed invention to modify compositions for mucosal suggested by Nishioka and Ruane by incorporating propylene glycol or triethylene glycol with a reasonable expectation of success. Since Nishioka teaches compositions comprising polyols like glycerin the skilled artisan would have found it obvious to substitute or combine propylene glycol or triethylene glycol as suggested in Lee with a reasonable expectation of success. The skilled artisan would have seen this modification as a substitution of one known polyol for another where each were known and used in compositions for mucosal lifting to achieve predictable results. Alternatively, the skilled artisan would have seen this modification as a combination of known polyols which were known as useful together in compositions for mucosal lifting to achieve predictable results. The skilled artisan would have had a reasonable expectation of success because each of the documents teach compositions effective to facilitate mucosal lifting in intestinal tissues.
Accordingly, the subject matter of claim 3 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A WAX can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WILLIAM CRAIGO/Examiner, Art Unit 1615
/SUSAN T TRAN/Primary Examiner, Art Unit 1615