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 .
Acknowledgement is made to Applicant’s response filed 01/28/2026.
All previously presented claims have been cancelled.
Claims 61-75 are newly added and 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Withdrawn Rejections
All grounds of rejection previously made have been withdrawn in view of all previously pending claims being cancelled.
New Grounds of Rejection – Necessitated by Applicant’s amendment to add said claims
Claim Objections
Claim 68 is objected to for reciting “aWenzel-Cassie.” This is deemed a typographical error that is intended to read “a Wenzel-Cassie.” Appropriate correction is required.
Claim Rejections - 35 USC § 112
35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, first paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 61-75 (all claims currently under consideration) are rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The response filed 01/28/2026 has introduced NEW MATTER into the claims.
Newly added claims 61 and 66 teach rehydration of the dehydrated phase with the addition of water to produce a water volume of 0.9% salt. Thus, the claim broadly encompasses using any water (not simply distilled water as articulated in the Specification) in order to achieve the volume of salt, which were not previously encompassed by the claims or the specification as originally filed. It is noted that claims 62-65 and 67-75 depend from said claims without resolving said issues.
Newly added claims 62, 66, and 67 recite a relationship of the structures as well as decreasing inter-microstructure spacing. Thus, the claim broadly encompasses particular relationships which were not previously encompassed by the claims or the specification as originally filed. It is noted that claims 68-75 depend from said claims without resolving said issues.
The response did not successfully point out where support for newly added claims 62, 66, and 67 could be found in the originally filed disclosure. Although the PTO has the initial burden of presenting evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims, when filing an amendment an applicant should show support in the original disclosure for new or amended claims. See MPEP 714.02 and 2163.06 (“Applicant should therefore specifically point out the support for any amendments made to the disclosure.”).
As presently amended, the claims now recite limitations, which were not clearly disclosed in the specification as filed, and now change the scope of the instant disclosure as filed. Such limitations recited in the presently amended claims, which did not appear in the specification, as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C 112. Applicant is required to provide sufficient written support for the limitations recited in the present claims in the specification or claims, as filed, or remove these limitations from the claims in response to this Office Action.
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 state that Applicant asserts are temporally separated.
It is noted that the characteristics (which are new matter) such as the relationship of the structures as well as decreasing inter-microstructure spacing, are not defined in the Specification, and as such, without any guidance in the Specification, it is deemed that these characteristics must be being considered as inherent aspects of hydrogel substrates and hierarchical microstructures since Applicant has given no guidance as to how to achieve these characteristics, or even articulated them in the Specification. With regard to what the composition is “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
It is noted that Applicant has cancelled all previously pending claims and replaced them with new claims. As such, arguments directed to the previously pending claims are not persuasive against the new claims which differ in scope. Wherein further, it is noted that Applicant’s arguments that are presented are directed to method steps, whereas the instant claims are directed to a product not a method.
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 characteristics (which are new matter) such as the relationship of the structures as well as decreasing inter-microstructure spacing, are not defined in the Specification, and as such, without any guidance in the Specification, it is deemed that these characteristics must be being considered as inherent aspects of hydrogel substrates and hierarchical microstructures since Applicant has given no guidance as to how to achieve these characteristics, or even articulated them in the Specification. With regard to what the composition is “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
It is noted that Applicant has cancelled all previously pending claims and replaced them with new claims. As such, arguments directed to the previously pending claims are not persuasive against the new claims which differ in scope. Wherein further, it is noted that Applicant’s arguments that are presented are directed to method steps, whereas the instant claims are directed to a product not a method.
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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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