Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined pursuant to the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of the Claims
Receipt of Applicants’ Response, filed 12 February 2026, is acknowledged. Claims 21, 23 – 25, 27, 33, 35, and 40 are amended therein. Accordingly, claims 21 – 30 are 33 - 42 are available for substantive consideration.
REJECTIONS WITHDRAWN
Rejections Pursuant to 35 U.S.C. § 112
The rejection pursuant to 35 U.S.C. § 112(b) set forth in the Action of 14 August 2025 is hereby withdrawn in light of Applicants’ amendment of the claims
Rejections Pursuant to 35 U.S.C. § 103
The obviousness rejection set forth in the Action of 14 August 2025 is hereby withdrawn in light of Applicants’ amendment of the claims and in favor of the new grounds of rejection set forth below.
NEW GROUNDS OF REJECTION
Rejections Pursuant to 35 U.S.C. § 103
The following is a quotation of 35 U.S.C. § 103 that 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.
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 absent any evidence to the contrary. Applicants are advised of the obligation pursuant to 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 21 – 30 and 33 - 42 are rejected pursuant to 35 U.S.C. § 103, as being obvious over US 2017/0232141 A1 to Surti, V., et al., published 17 August 2017, identified on the Information Disclosure Statement (IDS) filed 26 January 2023, cite no. A9 (“Surti ‘141”), in view of US 2003/0008011 A1 to Mershon, M., published 9 January 2003 (“Mershon ‘011”), and US 8,721,582 to Ji, X., issued 13 May 2014, identified on the Information Disclosure Statement (IDS) filed 17 August 2021, cite no. A4 (“Ji ‘582”).
The Examiner directs Applicants’ attention to the fact that the instant rejection applies the same references as applied in previous rejections of the claims pursuant to 35 U.S.C. § 103. However, the teachings of these references are applied in a manner different from how those teachings were applied in prior rejections, necessitated by Applicants’ amendment of claims 23, 27, and 35, thus constituting a new basis of rejection.
The Invention As Claimed
Applicants claim a formulation in the form of particles of a first material, and comprising at least one mucoadhesive agent totaling above 50% wgt of the formulation, wherein a portion of the particles are bound together, and wherein the bound particles include lighter particles bound to heavier particles, wherein the formulation further comprises calcium carbonate, present in a range of between about 10 - 15% wgt of the formulation, wherein particles in the powder are bound together by van der Waals bonding, and the bound particles have a minimum width of about 1 µm, wherein the bound particles have a maximum width of about 925 µm, and wherein a mass of the bound particles of the medical formulation is in a range of between about 0.0001 mg to about 0.5 mg per bound particle.
Applicants also claim a formulation comprising a first powder formed of particles of a first material, a second powder formed of particles of a second material comprising a hemostatic agent, wherein the particles of the first powder and the second powder are bound together to form bonded particles, wherein the bonded particles are filtered to a specific particle range size before being placed into a delivery device, wherein the particles of one of the first powder and the second powder is lighter than the other of the particles of the first powder and the second powder, wherein the bonded particles have a width in the range of about 1 µm to about 925 µm, wherein the formulation further comprises calcium carbonate, present in a range of between about 10 - 15% wgt of the formulation, wherein at least 10% of the particles of the first powder and the second powder are bound together, wherein a mass of the bonded particles is in a range of between about 0.0001 mg to about 0.5 mg per bonded particle, and wherein the particles of the first powder and the second powder are bound together by one of hydrogen bonding, van der Waals bonding, metallic bonding, ionic bonding, covalent bonding, chain entanglement, coating, impaction, or embedding.
In addition, Applicants claim a formulation comprising a first powder formed of particles of pectin as a mucoadhesive, and a second powder formed of particles of a hemostatic agent, wherein the particles of the mucoadhesive agent and the hemostatic agent are bound together to form bonded particles, wherein the particles of one of the first material and the second material are lighter than the particles of the other of the first material and the second material, wherein the hemostatic agent comprises a plant-based polysaccharide, wherein the bonded particles have a minimum width of about 1 micron, and wherein the bonded particles have a maximum width of about 925 microns, and wherein a mass of the bonded particles is in a range of between about 0.0001 mg to 0.5 mg per bonded particle, wherein the formulation further comprises calcium carbonate, present in a range of between about 10 - 15 % wgt of the formulation, wherein at least 10% of the particles are bound together by van der Waals bonding, wherein a mass of the bonded particles is in a range of between about 0.0015 mg to about 0.15 mg per bonded particle, and wherein the bonded particles exhibit a catheter diameter to particle width ratio of at least 4:1, wherein the catheter diameter is a projected inner diameter of a catheter for endoscopic delivery.
The Teachings of the Cited Art
Surti ‘141 discloses a medical product for protecting or treating a lesion in the gastrointestinal tract (see Abstract), wherein the product comprises a coating composition delivered at and about the site of the lesion by flowing through a catheter, wherein the coating comprises a hemostatic agent in powder form, as well as pectin and/or sodium carboxymethylcellulose as mucoadhesive agents (see ¶[0036]), also in powder form (see ¶[0011]), wherein the hemostatic agent is a natural, plant-based polysaccharide (see ¶[0024]), wherein the hemostatic coating composition comprises from 0.1% to greater than about 95% wgt of the composition (see ¶[0042]), and the mucoadhesive agents at from greater than 0.1% wgt to greater than 95% of the composition (see ¶[0043]), wherein the powders of the hemostatic coating composition may include finely divided or subdivided preparations, coarsely comminuted preparations, or products of intermediate particle size, the size depending on the type of agents used (see ¶[0044]), wherein a hemostatic component in the form of a powder can be a physical admixture of two or more powdered pure hemostatic agents (see ¶[0046]), wherein the mucoadhesive component may include one or more mucoadhesive agents, in the form of a powder that can be a physical admixture of two or more powdered pure mucoadhesive agents present in definite or differing proportions (see ¶[0047]), wherein the hemostatic composition and/or protective covering in the form of powders or granules can be reconstituted with a solvent or water or other liquid before use (see ¶[0049]), wherein the powders can be used by a physician as is, or mixed with a liquid for localized administration (see ¶[0051]), wherein the hemostatic coatings further comprise basic compounds that increase viscosity, such as calcium carbonate (see ¶[0054]), wherein, for multi-component coating compositions delivered in powder form, components may be bound together, resulting in single particles that contain multiple elements, such as fine mucoadhesive particles that are bound to larger barrier-forming particles (see ¶[0055]; see also FIG. 2), wherein the protective covering may also include a hemostatic agent that is the same or a different hemostatic agent as the hemostatic agent in the hemostatic composition, or may include a combination of two or more hemostatic agents (see ¶[0058]), and wherein the coatings can be applied or delivered to and about the site of the lesion with active bleeding through endoscopic techniques, laparoscopic techniques, or through direct access (i.e., surgically) using, for example, any suitable catheter delivery system (see ¶[0091]), and wherein the delivery system may include a delivery device that is sized and configured to deliver and apply the hemostatic composition and the protective covering directly at a targeted tissue region within a body lumen or hollow body organ, i.e., such as the site of the lesion, e.g., a lesion with an active bleeding in the gastrointestinal tract (see ¶[0095]). The reference does not expressly disclose compositions wherein the calcium carbonate is present at 10 – 15% wgt of the formulations, or compositions wherein at least 10% of the particles are bound together, or compositions wherein the bound particles have masses between about 0.0001 – about 0.5 mg/particle, or widths from 1 – 925 µm. The teachings of Mershon ‘011 and Ji ‘582 remedy these deficiencies.
Mershon ‘011 discloses methods for reducing and/or stopping bleeding or fluid loss from an open wound comprising the step of applying to the open wound a gel-forming composition, wherein the composition forms an aqueous gel having sufficient viscosity and adhesiveness to cover and adhere to the open wound so that bleeding is reduced and/or stopped (see Abstract), wherein desirable properties of the gels are improved for specific applications by combining the gel forming polymers with an alkaline thickening agent and/or additives such that, upon contact with water, ionic interactions that tend to increase gel viscosity are facilitated, and use of a calcium salt further improves fibrin-based clotting and gel formation (id.), wherein the compositions comprise one or more moderately alkaline salts of calcium, magnesium and/or sodium, or other moderately alkaline organic salts or bases (see ¶[0014]), wherein it is preferable that the salts provide divalent cations, such as Ca2+, that ionically cross-link polymer strands and increase mucilage viscosities to greater degree than monovalent cations, such as Na+ or K+, such that the divalent cations ionically cross-link polymer strands while reinforcing the mucilage and conferring properties such as resistance to abrasion and stiffness that are suitable for retention and function as an artificial scab (see ¶[0054]), wherein calcium and magnesium salts with limited solubility are preferred (see ¶[0058]), and wherein ratios of gel-forming polymer to calcium salt may vary over a wide range in compositions, for example, comprising up to 50% wgt of the gel-forming polymer and 50% of a calcium salt (see ¶[0074]).
Ji ‘582 discloses an internal dry powder delivery system through a working channel of an endoscopic cannula for directly applying a medication in powder form to an internal tissue/organ site (see Abstract), wherein the system overcomes the most common problems associated with delivering dry powder medication through the working channel of an endoscopic cannula, including that dry powder particles often occlude because of resistance in the long and narrow cannula through the working channel of an endoscope (see Col. 2, ll. 42 – 47), wherein the system can be used for various purposes, such as hemostatic, antibiotic, tissue repair, mucosal protection, ulcer repair, and antineoplastic treatment, etc. (see Col. 2, ll. 50 – 52), wherein the system enables physicians to directly apply biocompatible polysaccharide-containing hemostatic powders to bleeding sites via endoscope during invasive surgery to achieve hemostasis (see Col. 2, ll. 64 – 67), and wherein the dry powders used in the present invention refers to dry, smooth, and elastic particles that do not exceed 400 µm, with a preferred particle diameter between 1 and 250 µm (see Col. 5, ll. 39 – 42).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare a medical product for protecting or treating a lesion in the gastrointestinal tract (see Abstract), wherein the product comprises a composition delivered at the site of the lesion through a catheter, wherein the coating comprises a hemostatic agent in powder form, as well as pectin as a mucoadhesive agent, also in powder form, wherein the hemostatic agent is a natural, plant-based polysaccharide, wherein pectin contains functional groups capable of forming hydrogen bonds, wherein the product comprises a hemostatic agent that comprises from 0.1% to greater than about 95% wgt of the composition and a mucoadhesive agent at from greater than 0.1% wgt to greater than 95% of the composition, wherein the powders of the composition may include finely divided or subdivided preparations, coarsely comminuted preparations, or products of intermediate particle size, the size depending on the type of agents used, wherein the hemostatic coatings further comprise basic compounds that increase viscosity, such as calcium carbonate, wherein, for multi-component coating compositions delivered in powder form, components may be bound together, resulting in single particles that contain multiple elements, wherein the compositions can be applied or delivered to and about the site of a lesion with active bleeding through endoscopic techniques, laparoscopic techniques, or through direct access (i.e., surgically) using, for example, any suitable catheter delivery system, and wherein the delivery system may include a delivery device that is sized and configured to deliver and apply the hemostatic composition and the protective covering directly at a targeted tissue region within a body lumen or hollow body organ, i.e., such as the site of the lesion, as taught by Surti ‘141, wherein the compositions further comprise calcium carbonate, at loadings of up to 50% wgt, consistent with the teachings of Mershon ‘011, and wherein the composition of the product can be delivered to an internal tissue/organ site through a working channel of an endoscopic cannula for various purposes, such as hemostatic, antibiotic, tissue repair, mucosal protection, ulcer repair, and antineoplastic treatment, etc., wherein the dry powders do not exceed 400 µm, with a preferred particle diameter between 1 and 250 µm, as taught by Ji ‘582. One of ordinary skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the express teachings of Mershon ‘011 to the effect that inclusion of low solubility, mildly basic divalent salts, such as calcium carbonate, in order to neutralize the slightly acid carbomers in a hemostatic composition, and cross-link the polymer chains in order to increase viscosity of the compositions, increasing the ability of the compositions to adhere to a wound site, and by the teachings of Ji ‘582 to the effect that the disclosed system overcomes the most common problems associated with delivering dry powder medication, in the preferred particle sizes through the working channel of an endoscopic cannula, including that dry powder particles often occlude because of resistance in the long and narrow cannula through the working channel of an endoscope (see Col. 2, ll. 42 – 47).
With respect to the limitations newly added to claims 23, 27, and 35, the limitations directed to particles of one of the powders be heavier or lighter than the particles of the other powder that are bonded together, the Examiner notes that the cited references do not explicitly address such characteristics of the bonded particles. However, given the substantial identity between the components of the invention as claimed and the components of the cited art, as well as their mass loadings, it is the Examiner’s position that the bound particles of the cited art would necessarily comprise bound particles wherein one type of powder particle would be heavier or lighter than the other within the bonded particles, thus reading on the limitations in question.
With respect to claim 26, which claim recites a limitation directed to the compositions of the invention comprising calcium carbonate in a range of 10 – 15% wgt, the Examiner notes that Mershon ‘011 discloses that inclusion of calcium salts, such as mildly basic calcium carbonate, leads to neutralization of the carbomer polymer, leading to greater viscosity of the hemostatic composition, and further that Ca2+ salts cross-link polymer chains, further improving the mechanical properties of the hemostatic compositions. As for the concentration of calcium carbonate, as claimed in the range of 10 – 15% wgt, the Examiner notes that Mershon ‘011 discloses compositions with calcium carbonate at concentrations up to 50% wgt. Although the disclosed loading is not exactly congruent with the claimed range, it is the Examiner’s position that the cited art teaches a range of loadings of this component that significantly overlaps with the claimed loadings and, as such, would render the claimed invention obvious. See MPEP § 2144.05. “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).”
With respect to the limitation recited in claim 21 directed to at least a portion of the first and second powders being bound together, the Examiner notes that Surti ‘141 discloses that, for multi-component protective coatings delivered in powder form, components may be bound together, resulting in single particles that contain multiple elements, such as fine mucoadhesive particles that are bound to larger barrier-forming particles (see ¶[0055]). However, the reference does not expressly disclose the nature of the interactions that exist between the bound particles. In this regard, the Examiner further notes that Applicants’ specification, as well as claim 34, specifically discloses that the binding force holding the particles together can comprise hydrogen bonding and van der Waal’s forces, among others. It is the Examiner’s position that one of ordinary skill in the relevant art would appreciate that the disclosed forces reflect a wide range of binding energies, as well as numerous physicochemical processes leading to that binding. Furthermore, Surti ‘141 discloses that mucoadhesive agents, such as pectin, contain functional groups, such as carboxyl groups, hydroxyl groups, carbonyl groups, sulphate groups, amide groups, and other functional groups capable of forming hydrogen bonds (see ¶[0036]). Consequently, it is reasonable to conclude that one of ordinary skill in the art would recognize that the carbomer would be capable of binding to the polysaccharide through hydrogen bonds with the various active functional groups on the polymers. Furthermore, in the absence of any specific teachings directed to processes for achieving binding between the respective first and second powders, one of ordinary skill in the art could at least infer from these teachings that the binding processes can result from simple physical mixing of the powder components.
Therefore, in comparing Applicants’ disclosure with the teachings of the cited references, it is apparent that the references teach both the same powder components [plant-based polysaccharide and pectin/carboxymethylcellulose], and device loading processes, wherein the powder components are mixed upon loading into a container within the delivery device. Consequently, it is the Examiner’s position that adding the specific combination of polysaccharide and pectin/carboxymethylcellulose according to Surti ‘141 would necessarily result in at least some of the powders to bind together upon mixing in the device, up to 10% and more, thus meeting this limitation.
With respect to the limitations directed to the mass ranges and size ranges of the bound particles, the Examiner notes that the sizes and masses discloses in the cited references are not exactly congruent with the claim limitations. However, it is the Examiner’s position that the cited art teaches a range of loadings of these components that significantly overlap with the claimed loadings and, as such, would render the claimed invention obvious. See MPEP § 2144.05. “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).”
Furthermore, given the identity between the components disclosed in the cited art and the composition of the invention, at overlapping loadings, it is the Examiner’s position that the bonded particles comprising pectin and a plant-based polysaccharide would necessarily bond in a manner resulting in particle sizes that would read on the limitations in question.
Furthermore, Surti ‘141 teaches that delivery of the disclosed formulations to a wound site can be through use of a catheter (see ¶[0011]). Given the size constraints imposed by such delivery devices, as evidence by Applicants’ specification, at ¶[0036 (“It has been determined through multiple testing exercises that such ranges have criticality in terms of significantly reducing the likelihood of clogging of the catheter 90 during delivery”), adjustment or selection of particle sizes to read on the claim limitations would amount to nothing more than an optimization of a result-effective variable, the exercise of which is well with the expertise of one of ordinary skill in the appropriate art, particularly in light of the teachings of Surti ‘141 to the effect that the disclosed formulations are preferably delivered through a catheter. Consequently, in the absence of evidence as to the criticality of such parameter, this limitation cannot support patentability. See MPEP § 2144.05 II. A.
With respect to the mass ranges for the bound particles, the Examiner notes that the cited references do not disclose specific masses for the bound particles of the compositions. However, as one of ordinary skill in the art would recognize, the similar components would have similar densities so that, at the disclosed particle sizes, the particles would necessarily have masses reading on the limitations at issue.
With respect to claim 42, which claim recites limitations directed to characteristics of a catheter delivery device, the Examiner notes that the invention as claimed is directed to compositions, and not to a system comprising compositions in a delivery device, nor to a method of delivering compositions to the site of a lesion. Consequently, references in the claim to catheter characteristics are reasonably read as being directed to intended uses of the compositions of the invention, and not to the compositions of the invention. The compositions must be distinguished from the prior art by their structures or compositions. See Hewlett- Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990) (holding that “apparatus claims cover what a device is, not what a device does.’’). Statements of intended use or function normally are not given patentable weight because they are not structurally limiting. See Cochlear Bone Anchored Sols. AB v. Oticon Med. AB, 958 F.3d 1348, 1354-55 (Fed. Cir. 2020) (discussing effect of intended use recitations in claim preamble).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 21 – 30 and 33 – 42 would have been obvious within the meaning of 35 USC § 103.
Response to Applicants’ Arguments
The Examiner has considered Applicants’ arguments filed 12 February 2026, but does not find them persuasive. With respect to the limitations newly added to independent claims 23, 27, and 35, Applicants argue that the relevant teachings of the primary obviousness reference, Surti ‘141, discloses that “particles having different dimensions may be bound together to provide multi-component particles, the reference does not disclose that ‘the bound particles include lighter particles bound to heavier particles’ as now recited in independent claim 21.” Although Applicants correctly pointed out that the mass (or relative mass) of a particle is a function of both volume and density, it is the Examiner’s position that such consideration is not determinative of the question. In this regard, the Examiner would first note that the current claims do not recite limitations that identify a specific hemostatic agent, other than plant-based polysaccharides as a genus of hemostatic agents (claim 23 does not even identify or recite a limitation directed to a second powder), and only dependent claim 37 identifies pectin [a plant-based polysaccharide; cf. claim 35] as a specific mucoadhesive agent. Furthermore, none of the pending claims recite limitations directed to how many of the bound particles in the formulations of the invention would need to have component particles with different masses to come within the scope of the invention as claimed, nor limitations directed to the minimum mass difference between the components in the bound particle necessary to come within the scope of the invention.
Therefore, it is the Examiner’s position that given the lack of specific limitations directed to the identities of component particles, as well as a lack of specific limitations encompassing what percentage of the bonded particles would need to have components particles of different masses, or by how much the masses of the individual components would have to differ, there would necessarily be at least one bonded particle in formulations according to the teachings of the cited references that would comprise component particles of differing masses.
Consequently, based on the above discussion, Applicants’ arguments are unpersuasive, and claims 21 – 30 and 33 – 42 stand rejected as obvious pursuant to 35 U.S.C. § 103.
NO CLAIM IS ALLOWED.
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.
CONCLUSION
Any inquiry concerning this communication or any other communications from the Examiner should be directed to Daniel F. Coughlin whose telephone number is (571)270-3748. The Examiner can normally be reached on M - F 8:30 a.m. - 5:00 p.m.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, David Blanchard, can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/DANIEL F COUGHLIN/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619