DETAILED ACTION
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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/13/2026 has been entered.
Claims 61-75 are pending.
Claims 61-63 and 65-68 are currently amended.
Claims 61-75 are currently under consideration to the extent they read upon Applicant’s elected species.
Claim Interpretation
Newly added claims 61, 62, 66, and 68 refer to the concept of a “dehydrated phase.” It is noted that while this limitation does not have ipsissima verba support in the Specification or Claims as originally filed, Applicant has successfully argued in the Remarks filed 11/26/2025 that the Specification does provide support for said limitation to the extent that it corresponds to “the concept of removing water from the substrate.” Notably, this definition does not indicate the amount of water that is removed, rather, in order to be dehydrated, some water would have been removed. Further, for interpretation of a product claim, since a product claim is based on the structure of the product, not how it is made, a composition can be considered dehydrated if it is capable of containing more water.
Withdrawn Rejections and Objections
The objection to Claim 68 for reciting “aWenzel-Cassie” is withdrawn in view of Applicant’s Amendments. However, it is noted that Applicant did not properly mark this amendment in their response. Applicant is encouraged to followed the guidance in the MPEP for properly making amendments.
The rejection of claims 61-75 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of Applicant’s amendments to said claims removing the identified new matter.
Rejections Maintained and Made Again in view of Applicant’s Amendments
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 (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 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.
Claim(s) 61-75 (all claims currently under consideration) is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bluecher et al (WO 2013/112381).
Bluecher teaches a composition comprising a hierarchical hydrophobic-hydrophilic domain structured polymer endcapped with a biofunctional molecule can beneficially undergo morphological changes which are associated with the hydration of the hydrophilic domains and formation of pseudo-crosslinks via the hydrophobic component of the system, wherein the polymeric structures form biocompatible gels in vivo with extended persistence by virtue of the pseudo-crosslinks (see entire document, for instance, [0068]). The composition is capable of being utilized with an implantable device and anti-adhesion prosthetics (see entire document for instance, [0136] and [0024]). It is noted that when the composition is hydrated and the solid phase gels that the structures would hydrate, and thereby swell, increasing the volume and decreasing the distance between the structures. The composition is taught as having a morphology and shape that encourage entanglement, with useful structures including comb or brush structures (see entire document, for instance, Abstract). It is noted that comb and brush structures include portions that protrude from the main chain. Bluecher further teaches the presence of biofunctional molecules in an amount of 1/10 equivalent or 1/2 equivalent (10%-50%) (see entire document, for instance, [0144] and [0148]). Bluecher teaches that when the word “equivalent” is used, it is meant equivalent weight (see [0142]).
It is noted that the instant claims are directed to a composition, wherein the limitations directed to the medical device are considered intended use, wherein the prior art composition is deemed to be capable of being utilized in said intended uses. Further, the composition is deemed as being capable of performing the instantly claimed functions and targeting the identified targets. Again, these limitations are deemed intended use, and therefore, the composition, by its nature, is capable of performing said aspects, should it be placed within the proper context. Further, with regard to the amount of the salt in a rehydrated state, it is noted that if regular saline is utilized, the rehydrated composition would have a salt amount of 0.9%. It is again noted that the instant claims are directed to a product, where Applicant is attempting to claim two disparate states that Applicant asserts are temporally separated.
It is noted that the instant specification does not provide guidance how to achieve the claimed hierarchial microstructures, particularly there is no guidance with regard to how to how to create the first or second structures, and no indication of how to achieve the pyramids, hooks, bumps, or undulations. Based on the requirements that Applicant disclose how to make the product, the necessary conclusion is that the hierarchial microstructures are a result of the components present. Since the prior art teaches the instantly claimed components combined in the instantly required way, the structures must necessarily be present. It is noted that an argument that the microstructures would not be present would raise issues regarding written description. With regard to limitations directed to the composition being “capable” of, it is noted that the prior art teaches a composition that falls within the scope of the instant claims, wherein the composition is deemed to be capable of having said features or being used in said manner if placed in appropriate conditions.
Response to Arguments
Applicant argues in the Remarks filed 07/13/2026 that the prior art does not teach the instantly claimed two-tiered surface topography. Applicant’s argument is not found persuasive. Specifically, the instant Specification does not provide guidance as to how achieve the instantly claimed microstructures, wherein one of ordinary skill in the art would thereby conclude that by having the same composition as the instantly claimed composition, the “two-tiered surface topography” would necessarily be the same.
Applicant further argues that the prior art does not teach the instantly claimed saline rehydration. It is noted that the instant claims are directed to a product and recite comprising language. As such, it is noted that the first phase polymer gel is not required to have salt present. The process steps could include adding a water loaded with salt and removing both the water and the salt, the composition could then later be loaded with normal saline and result in the same final product.
Applicant additionally argues that the amounts taught in the prior art are directed to the weight of the functional groups, not the weight percent of the composition. Applicant’s argument is not found persuasive, Bluecher teaches the presence of biofunctional molecules in an amount of 1/10 equivalent or 1/2 equivalent (10%-50%) (see entire document, for instance, [0144] and [0148]). Bluecher teaches that when the word “equivalent” is used, it is meant equivalent weight (see [0142]).
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.
Claim(s) 61-75 (all claims currently under consideration) is/are rejected under 35 U.S.C. 103 as being unpatentable over Bluecher et al (WO 2013/112381).
Bluecher teaches a composition comprising a hierarchical hydrophobic-hydrophilic domain structured polymer endcapped with a biofunctional molecule can beneficially undergo morphological changes which are associated with the hydration of the hydrophilic domains and formation of pseudo-crosslinks via the hydrophobic component of the system, wherein the polymeric structures form biocompatible gels in vivo with extended persistence by virtue of the pseudo-crosslinks (see entire document, for instance, [0068]). The composition is capable of being utilized with an implantable device and anti-adhesion prosthetics (see entire document for instance, [0136] and [0024]). It is noted that when the composition is hydrated and the solid phase gels that the structures would hydrate, and thereby swell, increasing the volume and decreasing the distance between the structures. The composition is taught as having a morphology and shape that encourage entanglement, with useful structures including comb or brush structures (see entire document, for instance, Abstract). It is noted that comb and brush structures include portions that protrude from the main chain. Bluecher further teaches the presence of biofunctional molecules in an amount of 1/10 equivalent or 1/2 equivalent (10%-50%) (see entire document, for instance, [0144] and [0148]). Bluecher teaches that when the word “equivalent” is used, it is meant equivalent weight (see [0142]).
It is noted that the instant claims are directed to a composition, wherein the limitations directed to the medical device are considered intended use, wherein the prior art composition is deemed to be capable of being utilized in said intended uses. Further, the composition is deemed as being capable of performing the instantly claimed functions and targeting the identified targets. Again, these limitations are deemed intended use, and therefore, the composition, by its nature, is capable of performing said aspects, should it be placed within the proper context. Further, with regard to the amount of the salt in a rehydrated state, it is noted that if regular saline is utilized, the rehydrated composition would have a salt amount of 0.9%. It is again noted that the instant claims are directed to a product, where Applicant is attempting to claim two disparate state that Applicant asserts are temporally separated.
Bleucher, while teaching the instantly claimed composition, does not expressly assert that the first phase is dehydrated and the particular sizes or relationship of the microstructures.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instantly claimed invention to utilize a dry powder for the dehydrated form of the composition. One would have been motivated to do so since it is cheaper and easier to transport a dry composition compared with a hydrated composition. There would be a reasonable expectation of success since Bleucher discusses hydrating the composition.
Further, it would have been obvious to optimize the size and relationships of the microstructures of Bleucher. One would have been motivated do to so in order to arrive at a composition that best capitalizes on the hierarchical structure taught by Bleucher. There would be a reasonable expectation of success since optimization is well within the skillset and motivation of one of ordinary skill in the art.
It is noted that the instant specification does not provide guidance how to achieve the claimed hierarchial microstructures, particularly there is no guidance with regard to how to how to create the first or second structures, and no indication of how to achieve the pyramids, hooks, bumps, or undulations. Based on the requirements that Applicant disclose how to make the product, the necessary conclusion is that the hierarchial microstructures are a result of the components present. Since the prior art teaches the instantly claimed components combined in the instantly required way, the structures must necessarily be present. It is noted that an argument that the microstructures would not be present would raise issues regarding written description. With regard to limitations directed to the composition being “capable” of, it is noted that the prior art teaches a composition that falls within the scope of the instant claims, wherein the composition is deemed to be capable of having said features or being used in said manner if placed in appropriate conditions.
Response to Arguments
Applicant argues in the Remarks filed 07/13/2026 that the prior art does not teach the instantly claimed two-tiered surface topography. Applicant’s argument is not found persuasive. Specifically, the instant Specification does not provide guidance as to how achieve the instantly claimed microstructures, wherein one of ordinary skill in the art would thereby conclude that by having the same composition as the instantly claimed composition, the “two-tiered surface topography” would necessarily be the same.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TREVOR M LOVE whose telephone number is (571)270-5259. The examiner can normally be reached M-F typically 6:30-3.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at 5712726175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TREVOR LOVE/Primary Examiner, Art Unit 1611
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