DETAILED ACTION
Applicants’ arguments, filed 29 May 2026 and 23 June 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Withdrawn Rejections
The instant claims were previously rejected as anticipated by or obvious over Chen et al. (Springer Nature Applied Sciences, Vol. 1:609, 2019, 10 printed pages) and Yan et al. (Colloid and Polymer Science, Vol. 297, 2019, pages 705-717). These rejections have been withdrawn in view of the claim amendment requiring that the phenol derivative is 5-hydroxydopamine. Both Chen and Yan teach carboxymethylcellulose derivatized with dopamine. However, the dopamine of Chen and Yan is not the same as the 5-hydroxydopamine now required by the instant claims. As such, in view of this claim amendment, the rejections over Chen and Yan have been withdrawn.
The instant claims were previously rejected on the grounds of non-statutory double patenting over the claims of copending application 18/176,890. This rejection has been withdrawn. This is because the claims of the ‘890 application have been amended to recite hyaluronic acid modified with 5-hydroxydopamine. Hyaluronic acid is not a cellulose derivative as required by the instant claims.
Claim Interpretation
Claim 1 recites the term “modified.” The examiner has concentrated the search and examination on the case wherein the phrase “modified” means “covalently modified.” This is because such covalent modification is described later in the specification, e.g. as of page 4, paragraph [32]. With that being said, this should not be construed as a statement that the term “modified” is necessarily limited to covalent modification.
Claim 3 recites the following formula.
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For the purposes of examination under prior art, the examiner understands this figure to recite carboxymethylcellulose, in which some but not all of the carboxyl groups have been modified with R1. The examiner does not understand the above-figure as requiring an alternating copolymer in which a R1-modified group follows an unmodified group, which follows a R1 modified group which follows an unmodified group ad infinitum. Support for this position that the claims are not drawn to an alternating copolymer is obtained in the instant specification as of page 24 paragraph 191, as the process described in that paragraph would not have produced an alternating copolymer. As such, the examiner’s understanding of the figure in claim 3 in view of the specification is that the figure is intended to show modified carboxymethylcellulose and is not intended to show an alternating copolymer. Patents are given their broadest reasonable interpretation during examination, and in view of the specification, the examiner takes the position that it is reasonable to interpret claim 3 relatively broadly in that the claim not be understood to require an alternating copolymer. With all of that being said, an alternating copolymer is understood to be within the claim scope.
Claim 12 recites a composition for drug delivery. The examiner understands this to require that the composition is capable of drug delivery. It is not understood to require the presence of a drug. A prior art composition that would have been capable of drug delivery is understood to meet this claim limitation even if the prior art does not actually teach drug delivery.
The examiner notes that apparatus claims cover what the apparatus is, not what the apparatus does. See MPEP 2114(II), wherein the examiner understands the rationale in this section of the MPEP to apply to composition claims as well as apparatus claims. As such, a prior art composition capable of being used as a drug delivery vehicle is understood to meet the claim requirements even if the prior art does not teach use as a drug delivery vehicle.
In applicant’s response on 29 May 2026, applicant does not appear to have disputed the claim interpretation explanations previously provided in the prior office action mailed on 2 April 2026.
Claim Rejections - 35 USC § 102(a)(1) – Anticipation
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) 1, 3, and 6-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (KR 101982629 B1).
As an initial matter, Lee et al. (KR 101982629 B1) was written in Korean. The examiner has provided an English-language translation through Google Patents as of https://patents.google.com/patent/KR101982629B1/en?oq=kr+101982629+ on 15 July 2026. All page and paragraph citations (other than for drawings) will be to the Google Patents English translation, and the material cited therein is understood to have been present in the original Korean patent.
Lee et al. (hereafter referred to as Lee) is drawn to a pyrogallol containing polymer, as of Lee, page 1, title and abstract. The polymer of Lee has the following structure, as of Lee, page 22 of original Korean document, relevant structure reproduced below.
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As best understood by the examiner, this is understood to read on the required cellulose modified with 5-hydroxydopamine and is the same polymer as required by instant claim 3.
As to claim 1, the claim requires a hydrogel. Lee teaches a gel as of page 1, abstract. Lee also teaches distilled water, as of Lee, at least page 11, third to last paragraph. As such, as best understood by the examiner, this would have read on the required hydrogel.
As to claim 3, the formula reproduced above is understood to read on the formula required by claim 3.
As to claim 6, the claim requires that the hydrogel is adhesive. Lee does not appear to explicitly teach this. Nevertheless, when the structure recited in the reference is substantially identical to that required by the claims, the claimed properties or functions are presumed to be inherent. See MPEP 2112.01(I); also see MPEP 2112.01(II) and 2112(I & II). In this case, the chemical structure of Lee appears to be the same as what is required by the instant claims. As such, the skilled artisan would have expected that the compound of the prior art would have inherently had the required adhesive properties.
Additionally as to claim 6, once a reference teaching a product appearing to be substantially identical to the claimed product is made the basis of a rejection, and the examiner presents reasoning or evidence to show inherency, the burden of production shifts to applicant. See MPEP 2112(V). In this case, the product of Lee appears to have the identical chemical structure to the claimed product. As evidence or reasoning to show inherency, the examiner notes that Lee teaches that the composition is in the form of a gel, as of Lee, page 1, abstract. The examiner also notes the provisions of MPEP 2112.01(I & II). The examiner takes the position that this is sufficient to shift the burden to applicant in accordance with the provisions of MPEP 2112(V).
As to claim 7, the rationale presented by examiner regarding claim 6 is also understood to be applicable to claim 7.
As to claim 8, the claim recites the preamble “[a] hemostatic agent.” This appears to be a preamble statement reciting intended use, as per MPEP 2111.02(II). If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See MPEP 2111.02(II). In this case, the body of the claim recites the chemical structure. The preamble appears to state the purpose of use as a hemostatic. Therefore, the preamble is not understood to limit the claim, and claim 8 is rejected for essentially the same reason that claim 1 is rejected.
In the alternative as to claim 8, the examiner notes that the composition of Lee has the same structure as the instantly claimed composition. Therefore, the skilled artisan would have expected the composition of Lee to have been capable of having acted as a hemostatic even if this was not recognized by Lee. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer, and this need not have been discovered at the time of filing. See MPEP 2112(I & II). Additionally, apparatus claims cover what the apparatus is, not what the apparatus does. See MPEP 2114(II), wherein the examiner understands this section of the MPEP to refer to chemical composition claims as well as apparatus claims. In this case, the composition of Lee is the same as the claimed composition even if it has been intended to do something different because the composition of Lee has the same chemical structure as the claimed composition. The rationale under MPEP 2112(V), which the examiner applied to claim 6, also applies to claim 8.
As to claim 9, because the composition of Lee has the same chemical structure as the claimed invention, the skilled artisan would have expected the composition of Lee to have naturally formulated into the same form (e.g. of an adhesive patch or film) as the claimed composition. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP 2112.01(II).
As to claim 10, the positions taken by the examiner above relying upon MPEP 2112 and 2114(II), as applied to claims 6-9, also apply to claim 10.
As to claim 11, the positions taken by the examiner above relying upon MPEP 2112 and 2114(II), as applied to claims 6-9, also apply to claim 11.
As to claim 12, the examiner takes the position that the claimed requirement “for drug delivery” requires that the composition is capable of being used to deliver a drug. It is not understood to require that a drug is actually loaded. Therefore, because the chemical structure of the prior art is the same as the chemical structure of the claimed invention, the prior art composition would therefore have been capable of having been used for drug delivery. See MPEP 2112(I & II), 2112.01(I & II), 2114(II), and 2112(V), all of which have been discussed in greater detail above.
Claim Rejections - 35 USC § 103 – Obviousness
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) 1, 3-4, and 6-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (KR 101982629 B1).
Lee et al. (hereafter referred to as Lee) is drawn to a pyrogallol containing polymer, as of Lee, page 1, title and abstract. The polymer of Lee has the following structure, as of Lee, page 22 of original Korean document, relevant structure reproduced below.
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As best understood by the examiner, this is understood to read on the required cellulose modified with a phenol derivative.
As to claim 1, the claim requires a hydrogel. Lee teaches a gel as of page 1, abstract. Lee also teaches distilled water, as of Lee, at least page 11, third to last paragraph.
As to claim 1, purely en arguendo and for the purposes of this ground of rejection only, the examiner understands that Lee teaches all of the claimed requirements; namely, the required polymer and a hydrogel, but not together in the same embodiment in that Lee does not anticipate the derivatized carboxymethylcellulose in the form of a hydrogel. As such, purely en arguendo and for the purposes of this ground of rejection only, the examiner understands that while the prior art teaches all of the claimed components, for the purposes of this ground of rejection, the examiner understands, purely en arguendo, that the prior art is not anticipatory insofar as these components must be selected from various lists/locations in the prior art reference. It would have been prima facie obvious; however, to have selected the recited components from various lists/locations in the prior art reference and to have combined them together. This is because such a modification would have represented nothing more than the predictable use of prior art components according to their established functions. Combining separate prior art components (from a single prior art reference) according to known methods to yield predictable results is prima facie obvious. See MPEP 2143, Exemplary Rationale A.
As to claim 3, the formula reproduced above is understood to read on the formula required by claim 3.
As to claim 4, this claim appears to require the mole ratio of the phenol derivative (e.g. 5-hydroxydopamine, also known as pyrogallol, and carboxymethyl cellulose). Lee teaches both components, but is silent as to the mole ratio between the components. Nevertheless, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of a polymer made from carboxymethyl cellulose covalently conjugated to 5-hydroxydopamine has been taught by the prior art; (though while the prior art uses the term pyrogallol instead of 5-hydroxydopamine, these appear to be the same thing). As such, it would not have been inventive for the skilled artisan to have discovered the optimum or workable ranges of these components via routine experimentation.
As to claim 6, the claim requires that the hydrogel is adhesive. Lee does not appear to explicitly teach this. Nevertheless, when the structure recited in the reference is substantially identical to that required by the claims, the claimed properties or functions are presumed to be inherent. See MPEP 2112.01(I); also see MPEP 2112.01(II) and 2112(I & II). In this case, the chemical structure of Lee appears to be the same as what is required by the instant claims. As such, the skilled artisan would have expected that the compound of the prior art would have inherently had the required adhesive properties.
Additionally as to claim 6, once a reference teaching a product appearing to be substantially identical to the claimed product is made the basis of a rejection, and the examiner presents reasoning or evidence to show inherency, the burden of production shifts to applicant. See MPEP 2112(V). In this case, the product of Lee appears to have the identical chemical structure to the claimed product. As evidence or reasoning to show inherency, the examiner notes that Lee teaches that the composition is in the form of a gel, as of Lee, page 1, abstract. The examiner also notes the provisions of MPEP 2112.01(I & II). The examiner takes the position that this is sufficient to shift the burden to applicant in accordance with MPEP 2112(V).
As to claim 7, the rationale presented by examiner regarding claim 6 is also understood to be applicable to claim 7.
As to claim 8, the claim recites the preamble “[a] hemostatic agent.” This appears to be a preamble statement reciting intended use, as per MPEP 2111.02(II). If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See MPEP 2111.02(II). In this case, the body of the claim recites the chemical structure. The preamble appears to state the purpose of use as a hemostatic. Therefore, the preamble is not understood to limit the claim, and claim 8 is rejected for essentially the same reason that claim 1 is rejected.
In the alternative as to claim 8, the examiner notes that the composition of Lee has the same structure as the instantly claimed composition. Therefore, the skilled artisan would have expected the composition of Lee to have been capable of having acted as a hemostatic even if this was not recognized by Lee. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer, and this need not have been discovered at the time of filing. See MPEP 2112(I & II). Additionally, apparatus claims cover what the apparatus is, not what the apparatus does. See MPEP 2114(II), wherein the examiner understands this section of the MPEP to refer to chemical composition claims as well as apparatus claims. In this case, the composition of Lee is the same as the claimed composition even if it has been intended to do something different because the composition of Lee has the same chemical structure as the claimed composition.
As to claim 9, because the composition of Lee has the same chemical structure as the claimed invention, the skilled artisan would have expected the composition of Lee to have naturally formulated into the same form (e.g. of an adhesive patch or film) as the claimed composition. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP 2112.01(II).
As to claim 10, the positions taken by the examiner above relying upon MPEP 2112 and 2114(II), as applied to claims 6-9, also apply to claim 10.
As to claim 11, the positions taken by the examiner above relying upon MPEP 2112 and 2114(II), as applied to claims 6-9, also apply to claim 11.
As to claim 12, the examiner takes the position that the claimed requirement “for drug delivery” requires that the composition is capable of being used to deliver a drug. It is not understood to require that a drug is actually loaded. Therefore, because the chemical structure of the prior art is the same as the chemical structure of the claimed invention, the prior art composition would therefore have been capable of having been used for drug delivery. See MPEP 2112(I & II), 2112.01(I & II), 2114(II), and 2112(V), all of which have been discussed in greater detail above. Additionally, Lee teaches drug delivery capsules, as of the paragraph bridging pages 3-4 of the translation.
As to claim 13, Lee teaches drug delivery capsules, as of the paragraph bridging pages 3-4 of the translation. As such, the skilled artisan would have been motivated to have loaded a drug. The examiner notes that although drug delivery capsules are not the main focus of Lee, this is still part of the teachings of Lee. Rejections over the prior art’s broad disclosure are proper; see MPEP 2123.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (KR 101982629 B1) in view of Hanzen et al. (US 2007/0166371 A1).
Lee is drawn to a composition comprising the following polymer.
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Although the primary use of this polymer is in lithium batteries, Lee does suggest use for a capsule for drug delivery in the paragraph bridging pages 3-4 of the translation.
Lee does not teach an antibiotic, as required by claim 14.
Hanzen et al. (hereafter referred to as Hanzen) is drawn to pharmaceutical capsules comprising carboxymethylcellulose derivatives, as of Hanzen, title and abstract. Hanzen teaches antibiotics, as of Hanzen, paragraphs 0030 and 0035.
Hanzen does not teach derivatization of the carboxymethylcellulose with 5-hydroxydopamine.
It would have been prima facie obvious for one of ordinary skill in the art to have used the composition of Lee to have delivered the antibiotic of Hanzen. Lee is drawn to a composition comprising a carobxymethylcellulose derivatized with 5-hydroxydopamine. This composition may be used as a drug delivery capsule, as of Lee, paragraph bridging pages 3-4 of translation. While Lee is silent as to the type of drug to be delivered, Hanzen indicates that drug delivery vehicles made from carboxymethylcellulose derivatives can be used for delivery of antibiotics. As such, the skilled artisan would have been motivated to have used the composition of Lee for predictable delivery of an antibiotic with a reasonable expectation of success.
Response to Declaration Under 37 C.F.R. 1.132
A declaration under 37 C.F.R. 1.132 was presented with applicant’s response on 23 June 2026. In this declaration, declarant compares the claimed invention against a comparative example of dopamine-derivatized carboxymethylcellulose. This is not sufficient to overcome the applied rejections. As an initial matter, evidence of secondary considerations, such as unexpected results or commercial success, is irrelevant to 35 U.S.C. 102 rejections and thus cannot overcome a rejection so based. See MPEP 2131.04. Additionally, an affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. See MPEP 716.02(e). In this case, the composition of Lee is closer to the claimed invention than is the comparative example of dopamine-derivatized carboxymethylcellulose in the declaration. This is because the polymer of Lee appears to have the same structure as the claimed polymer, whereas the dopamine-derivatized carboxymethylcellulose of the declaration differs from the claimed polymer by having one less hydroxyl group.
Response to Arguments
Applicant has presented arguments in applicant’s responses on 29 May and 23 June 2026. These arguments appear to relate to rejections which have been withdrawn. As such, applicant’s arguments are moot and will not be addressed substantively by the examiner.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
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, Sahana Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612
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