Prosecution Insights
Last updated: April 19, 2026
Application No. 18/496,799

PROTEIN FUNCTIONALIZED HYALURONIC ACID COATED CHITOSAN NANOPARTICLE AND METHOD OF PREPARATION

Final Rejection §102§103§112
Filed
Oct 27, 2023
Examiner
WHEELER, THURMAN MICHAEL
Art Unit
1619
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
King Abdulaziz City For Science And Technology
OA Round
2 (Final)
46%
Grant Probability
Moderate
3-4
OA Rounds
4y 0m
To Grant
69%
With Interview

Examiner Intelligence

Grants 46% of resolved cases
46%
Career Allow Rate
277 granted / 608 resolved
-14.4% vs TC avg
Strong +23% interview lift
Without
With
+23.4%
Interview Lift
resolved cases with interview
Typical timeline
4y 0m
Avg Prosecution
45 currently pending
Career history
653
Total Applications
across all art units

Statute-Specific Performance

§101
0.5%
-39.5% vs TC avg
§103
52.1%
+12.1% vs TC avg
§102
8.9%
-31.1% vs TC avg
§112
22.5%
-17.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 608 resolved cases

Office Action

§102 §103 §112
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 . DETAILED ACTION Claims 1-13 are pending in the Claim Set filed 11/14/2025. Applicants elected Group I: claims 1-8, in the reply filed on 5/6/2025. Applicant elected to prosecute the protein functionalized anti-inflammatory HA-CS NP, of which is configured as a nano-coating in or on a medical device, as recited in claim 6. Applicants stated in the reply filed 5/6/2025 that the elected species reads on claims 1-6. Claims 1, 2, 4, 5 and 6 have been amended in the Instant Claim Set filed 11/14/2025. Claims 7-13 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention. Herein, claims 1-6 are for examination. Withdrawn Objections/ Rejections Objections to claims 2 and 4 are withdrawn in view of the claim amendments. The rejections of claims 2 and 4 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention are withdrawn in view of the claim amendments. Claim Objections Claim 5 recites: The surface functionalized nanoparticle of claim 1, wherein the functionalized nanoparticle forms a medical device nano-coating (instant claim 5); For consistency to claim 1, claim 5 should be amended to recite: The surface functionalized nanoparticle of claim 1, wherein the surface functionalized nanoparticle forms a medical device nano-coating. Claim Rejections - 35 USC § 112 The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph: 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. The rejection of claims 5 and 6 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 is maintained and made again. This rejection has been reformulated in view of amendments to claims. This is a New Matter rejection. Claim 5 (Currently Amended) recites: The surface functionalized nanoparticle of claim 1, wherein the functionalized nanoparticle forms a medical device nano-coating. Claim 6 (Currently Amended) recites: The surface functionalized nanoparticle of claim 5, wherein the medical device nano-coating forms a nano drug delivering system. A complete search of Instant Specification did not provide support for the phrase: ‘medical device nano-coating’. Further, the Examiner would like to point out that the term ‘medical’ is not disclosed in Instant Specification. Applicants argue in the reply filed 11/14/2025 that the as-filed specification provides written description support for the phrase "medical device." Applicants argue: First, the as-filed specification reasonably conveys surface functionalized nanoparticles used at device-tissue interfaces to reduce immune activation (Specification at [0030]-[0031]), and a person of ordinary skill in the art would understand that the functionalized nanoparticles function as a medical device. Applicant’s arguments have been fully considered but they are not persuasive, because there is no mention of surface functionalized nanoparticles used at device-tissue interfaces in para. [0030]-[0031]. Notably, para. [0030] states (in part): significant migration inhibition indicative of significant immune suppressions, exerted by AGP-HA-CS NPs when compared to free AGP and HA-CS NPs was observed, especially in the first 24 hours. AGP, therefore is required to be adsorbed onto NPs for enhanced immune suppression as opposed to free AGP. Further, para. [0031] states (in part): In another embodiment, the protein functionalized anti-inflammatory HA-CS NP with surface adsorbed proteins AGP is employed in a drug delivery system. Thus, there is no support for ‘the functionalized nanoparticle forms a ‘medical device’ nano-coating. Furthermore, employing a protein functionalized anti-inflammatory HA-CS NP with surface adsorbed proteins AGP in a drug delivery system fails to provide support for a ’medical device nano-coating’, i.e., the phrase: in a drug delivery system, does not provide support for a nano-coating on a medical device (medical device nano-coating). Applicants argue: Second, the specification emphasizes that the disclosed nanoparticles are designed to prevent or reduce acute inflammation, to suppress immune activation, and to enhance circulation time in biological environments. Specification at [0002]-[0004]. A person of ordinary skill in the art would similarly understand that the claimed nanoparticles function as a medical device. Applicant’s arguments have been fully considered but they are not persuasive, because the phrase: medical device nano-coating, is a coating on a medical device and not nanoparticles that function as a medical device. Applicants argue: Finally, the specification discloses nanoparticles having external protein coronas that achieve the above-desired effects through surface-bound proteins (e.g., AGP) interacting with the surrounding biological environments. Specification at [0028]-[0031]. Specifically, the specification discloses AGP-coated nanoparticles reducing inflammatory cell behavior in a wound-closure model using activated breast-cancer cells, demonstrating that the nanoparticles' surface coating can reduce inflammation at points of cellular contact. Specification at [0030]-[0031 ]. A skilled artisan would thus understand that the described compositions could be applied to, or incorporated within, a medical device surface to impart those same biocompatibility and anti-inflammatory properties as described in the original disclosure. Applicant’s arguments have been fully considered but they are not persuasive, because the phrase: demonstrating that the nanoparticles' surface coating can reduce inflammation at points of cellular contact, fails to provide support for a medical device nano-coating. The phrase: demonstrating that the nanoparticles' surface coating can reduce inflammation at points of cellular contact is directed to the AGP-coated nanoparticles, i.e., AGP protein coated on the nanoparticles and not to a medical device nano-coating. M.P.E.P. §2163 states that new or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. Thus, the disclosure does not provide support for the claim amendments by changing the scope of the disclosure; thereby, constituting new matter. New Grounds of Rejection necessitated by claim amendments Claim Rejections - 35 USC § 112 The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph: 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. The rejection of claims 1-6 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 is maintained and made again. This rejection has been reformulated in view of amendments to claims. This is a New Matter rejection. Claim 1 (Currently Amended) recites: A surface functionalized nanoparticle comprising: a central core and an outer shell surrounding the central core, the central core comprising a hyaluronic acid coated chitosan nanoparticle, and the outer shell comprising at least one functionalized surface adsorbed anti-inflammatory protein forming a protein corona on an external surface of the central core. A complete search of Instant Specification did not provide support for the phrase: ‘forming a protein corona on an external surface of the central core’. Specification para. [0017] states: In one embodiment, a combination of anti-inflammatory proteins ITIH4 and AGP are bound to the central core HA-CS NP, forming stabilized nanoparticle systems by virtue of the strong covalent bonds formed between the anti-inflammatory proteins rendering a stable protein corona. Specification para. [0018] states: In another embodiment, the anti-inflammatory proteins bound to the central core may include either ITIH4 or AGP. Specification para. [0023] states: The inflammatory proteins bound to the HA-CS NP is selected from either ITIH4 or AGP. In another embodiment, the central core is functionalized with a combination of ITIH4 and AGP. Therefore, Instant Specification discloses that anti-inflammatory proteins are bound to the central core, but does not provide support for the limitation: a protein corona on an external surface of the central core. M.P.E.P. §2163 states that new or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. Thus, the disclosure does not provide support for the claim amendments by changing the scope of the disclosure; thereby, constituting new matter. The remaining claims are rejected as depending from a rejected claim. Applicants may consider amending claim 1 to recite: Claim 1: A surface functionalized nanoparticle comprising: a central core and an outer shell surrounding the central core, the central core comprising a hyaluronic acid coated chitosan nanoparticle, and the outer shell comprising at least one functionalized surface adsorbed anti-inflammatory protein bound to the central core forming a protein corona Claim Rejections - 35 USC § 102 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. The rejection of claims 1 and 3-6 under 35 U.S.C. 102(a)(1) as being anticipated by Corrigan et al (US 20140038894) is maintained and made again. This rejection has been reformulated necessitated by amendments to claims. Regarding claim 1, Corrigan teaches hyaluronic acid (HA)-coated chitosan (CS) nanoparticles (i.e., central core) loaded with a protein (calcitonin) having anti-inflammatory properties, e.g., for the treatment of arthritis or proliferative cancers (Abstract; [0004-0011]; [0017-0018]; [0030-0031; [0046]; [0049]; [0052]; [0055-0057]; [0157], Example 16; See entire document). Corrigan teaches that the inventors have complexed calcitonin (Ct) in hyaluronic acid and chitosan-based polymeric nanoparticles to yield a complex with enhanced biopharmaceutical and therapeutic properties over the single agents, calcitonin and hyaluronic acid [0004]; [0096-0097], See Example 4. Particularly, Corrigan teaches disposition of calcitonin (Ct) (i.e., protein) on the particle surface [0103] (i.e., adsorption of a protein forming a corona). Thus, Corrigan teaches a hyaluronic acid (HA)-coated chitosan (CS) nanoparticle (HA-CS) loaded with a protein (calcitonin) having a protein (e.g., calcitonin (Ct)) adsorbed on the surface of a HA-CS nanoparticles, of which would necessarily provide forming a corona on an external surface of the central (i.e., proteins adsorbed on the surface) on the HA-CS nanoparticles. The limitation recited in amended claim 1: ‘forming a protein corona on an external surface of the central core’ is directed to a product-by-process. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself product (i.e., a surface functionalized nanoparticle). The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP § 2113. In the instant case, Corrigan teaches disposition of calcitonin (Ct) (i.e., anti-inflammatory protein) adsorbed on the particle surface, of which would necessarily provide a surface functionalized nanoparticle comprising a central core comprising HA-CS nanoparticle and an outer shell comprising at least one functionalized surface adsorbed anti-inflammatory protein, e.g., calcitonin, that forms a protein corona on an external surface of the central core, and is therefore the same product as instantly claimed. Regarding claim 3, Corrigan teaches functionalized HA-CS-protein (calcitonin) nanoparticles in the range of 177-229 nanometers ([0106], Table 4F). Therefore, the claimed range of 170-270 nanometers is anticipated by the prior art range as taught by Corrigan. Regarding claim 4, Corrigan teaches functionalized HA-CS-protein (calcitonin) nanoparticles have potential in treating inflammatory arthritis of joints through down-regulation of the NR4A nuclear receptor family and a range of metalloproteinases following, for example, systemic and intra-articular injection [0004]. Corrigan teaches that the polymeric nanoparticle comprising hyaluronic acid, chitosan and calcitonin (Ct) delivered in a single injection by the intraarticular (IA) route to the knee on reducing knee diameter over time, ([0072], see Figure 10). Thus, it would necessarily follow that the anti-inflammatory protein: calcitonin, is biocompatible. Regarding claims 5 and 6. The limitation recited in amended claims 5 and 6, respectively: wherein the functionalized nanoparticle forms a medical device nano-coating (instant claim 5); wherein the medical device nano-coating forms a nano drug delivering system (instant claim 6); are limitations directed to a product-by-process. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself product (i.e., a surface functionalized nanoparticle). The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP § 2113. In the instant case, Corrigan teaches disposition of calcitonin (Ct) (i.e., anti-inflammatory protein) adsorbed on the particle surface, of which would necessarily provide a surface functionalized nanoparticle comprising a central core comprising HA-CS nanoparticle and an outer shell comprising at least one functionalized surface adsorbed anti-inflammatory protein, e.g., calcitonin, that forms a protein corona on an external surface of the central core, and is therefore the same product as instantly claimed. Therefore, the surface functionalized nanoparticle as taught by Corrigan would necessarily provide: a functionalized nanoparticle that forms a medical device nano-coating (instant claim 5); the surface functionalized nanoparticle of claim 5, wherein the functionalized nanoparticle forms a nano-coating delivering system (instant claim 6); Therefore, a surface functionalized nanoparticle as recited in claims 1 and 3-6 is anticipated by Corrigan. Response to Arguments Applicants argue in the reply filed 11/14/2025, as amended, independent claim 1, recites "the outer shell comprising at least one functionalized surface adsorbed anti-inflammatory protein forming a protein corona on an external surface of the central core." Corrigan teaches nanoparticles formed by co-assembling hyaluronic acid, chitosan, and a therapeutic agent during nanoparticle fabrication. The Office cites Corrigan's discussion of calcitonin (i.e., a protein) "on the particle surface" and that a protein "adsorbed on the surface ... provides a corona", however, Corrigan's calcitonin association occurs incidentally during co-assembly of the hyaluronic acid, chitosan, and the therapeutic material within the polymeric matrix, where the protein is subsequently released to elicit bioactivity, not immobilized to form a stable outer shell. Furthermore, Corrigan teaches that calcitonin is entrapped within the nanoparticle and subsequently released to elicit bioactivity. Thus, Corrigan teaches a controlled release of the therapeutic agent, not a purposeful formation of an outer, stable protein shell, as disclosed and claimed. Corrigan does not teach intentional post-fabrication surface adsorption to generate a corona. By contrast, the instant specification expressly describes functionalizing the already-formed HA-CS nanoparticle with surface-adsorbing anti-inflammatory proteins, which creates a structurally distinct external layer. Applicant’s arguments have been fully considered but they are not persuasive, because the limitation recited in amended claim 1: ‘forming a protein corona on an external surface of the central core’ is directed to a product-by-process. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself product (i.e., a surface functionalized nanoparticle). The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP § 2113. In the instant case, Corrigan teaches disposition of calcitonin (Ct) (i.e., anti-inflammatory protein) adsorbed on the particle surface, of which would necessarily provide a surface functionalized nanoparticle comprising a central core comprising HA-CS nanoparticle and an outer shell comprising at least one functionalized surface adsorbed anti-inflammatory protein, e.g., calcitonin, that forms a protein corona on an external surface of the central core, and is therefore the same product as instantly claimed. Moreover, Corrigan explicitly teaches the zeta potential of the polymeric nanoparticles became less negative with the increase in sCT (calcitonin protein) concentration, thus indicating the disposition of the sCT (calcitonin protein) on the particle surface [0103] (i.e., involves the formation of protein corona). When there is no physical evidence to support or a reason to believe that a patentably distinct structure is imparted by the process steps (i.e., forming a protein corona) the burden of proving otherwise falls to the Applicants’. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. See MPEP § 2113. Furthermore, Instant Claims recite the transitional term comprising, which is open-ended and does not exclude additional, unrecited elements or method steps. See, e.g. Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004). Thus, the subject matter of Instant Claims does not exclude sCT (calcitonin protein) being co-assembled and entrapped within the HA-CS nanoparticles Instant specification at para. [0014] states: [0014] In this document, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article or composition that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article or composition. An element proceeded by "comprises ... a" does not, without more constraints, preclude the existence of additional identical elements in the process, method, article or composition that comprises the element. In response to Applicant's argument that the references fail to show certain features of Applicant’s invention, it is noted that the features upon which Applicant relies (i.e., immobilized to form a stable outer shell) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). 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. 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(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 The rejection of claims 1-6 under 35 U.S.C. 103 as being unpatentable over Corrigan et al (US 20140038894) in view of Kiss (US 2007/0014777) is maintained and made again. This rejection encompasses the reformulated teachings of Corrigan as described above necessitated by amendments to instant claims. The teachings of Corrigan are described above in regards to claims 1 and 3-6. Corrigan differs from the claims in that the document does not teach that the protein is alpha-1-acid glycoprotein (AGP). Regarding claim 2, However, Kiss cures the deficiency. Kiss teaches that alpha-1-acid glycoprotein (AGP) is a protein that regulates the inflammation process [0007], of which can be provided in compositions designed to decrease inflammation [0008]. Kiss teaches AGP may be applied by one of the injection methods used in the medical practice [0015]. Kiss teaches that AGP is known to exert anti-inflammatory effects, wherein its anti-inflammatory effects are due to its ability to reduce extravasation of leukocytes into the surrounding tissue, wherein AGO is considered a natural anti0inflammatory protein. Additionally, AGP is also known to inhibit both complement and neutrophil-mediated injuries ([0060]; [0089]); See entire document). Kiss teaches based on AGP anti-inflammatory properties, in case of non-chronic wounds, AGP is included, for example, in a composition that is used several days after the injury. This is when a decrease in the level of inflammation is desired in order to facilitate progression of the wound healing process. In case of chronic wounds, when inflammation probably needs to be controlled, AGP may be included in the wound healer composition from the start [0090]. Moreover, Kiss teaches that AGP is linked to nanoparticle, wherein nanoparticle-bound proteins may provide a more localized and sustained response because they are less diffusible than proteins suspended in the above carriers in the absence of nanoparticles ([0106]; 0145]). Thus, it would have been prima facie obvious to substitute AGP for calcitonin (protein) in view of that both substances are established and well known as anti-inflammatory proteins as taught by the cited references. Moreover, Kiss teaches that AGP is linked to a nanoparticle, wherein the benefit of doing so comprises that a AGP protein linked to a nanoparticle is more localized and thereby enhances sustained response because they are less diffusible than proteins suspended in a carrier. All the claimed elements herein are known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide instantly claimed antimicrobial composition and one of ordinary skill would have had a reasonable expectation of success in producing the claimed invention. Therefore, in the absence of evidence to the contrary, the surface functionalized nanoparticle as claimed as a whole would have been obvious to one of ordinary skill as evidenced by Corrigan ad Kiss, as a whole. Response to Arguments Applicants argue that Kiss does not cure the deficiencies of Corrigan because Kiss is relied upon for teaching anti-inflammatory proteins such as alpha-1 acid glycoprotein (AGP) to regulate the inflammation process and decrease inflammation. However, Kiss describes these proteins in soluble topical formations rather than in an immobilized form. Kiss applies these proteins as compositions that "contain at least two proteins that are dissolved or dispersed in physiologically compatible carriers and are administered either topically or via injection," and further that "therapeutically effective amounts of AT, PALP, TF or AGP in various combinations dissolved or dispersed in physiologically compatible carriers." Using immobilized AGP would contradict the free carrier-based delivery upon which Kiss relies. Furthermore, the Office has not articulated a reason why a person of ordinary skill would depart from Corrigan's internal therapeutic distribution to adopt Kiss's carrier-based proteins in an immobilized surface-bound configuration. Applicant’s arguments have been fully considered but they are not persuasive, because it would have been prima facie obvious to substitute AGP for calcitonin (protein) in view of that both substances are established and well known as anti-inflammatory proteins as taught by the cited references. Moreover, Kiss teaches that AGP is linked to a nanoparticle, wherein the benefit of doing so comprises that a AGP protein linked to a nanoparticle is more localized and thereby enhances sustained response because they are less diffusible than proteins suspended in a carrier. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize AGP protein as taught by Kiss, in substitution for the calcitonin (protein) of Corrigan. One would have been motivated to do so since Kiss sets forth the equivalence of AGP protein as an anti-inflammatory protein. It is noted that MPEP 2144.06(11) states ‘an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297,213 USPQ 532 (CCPA 1982)’. Conclusions 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. Contact Information Any inquiry concerning this communication or earlier communications from the examiner should be directed to Thurman Wheeler whose telephone number is (571)-270-1307. The examiner can normally be reached Monday-Friday 11:00am-5:00pm EST. 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, 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /T.W./ Examiner, Art Unit 1619 /SARAH ALAWADI/ Primary Examiner, Art Unit 1619
Read full office action

Prosecution Timeline

Oct 27, 2023
Application Filed
Aug 12, 2025
Non-Final Rejection — §102, §103, §112
Nov 14, 2025
Response Filed
Feb 18, 2026
Final Rejection — §102, §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
46%
Grant Probability
69%
With Interview (+23.4%)
4y 0m
Median Time to Grant
Moderate
PTA Risk
Based on 608 resolved cases by this examiner. Grant probability derived from career allow rate.

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