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 .
Status of Application
The Amendments and Remarks filed on 01/15/26 are acknowledged.
Claims 1, 3, 6, 9, 12, 15-16, 19-22, and 25 were amended.
Claims 1-25 are pending and included in the prosecution.
Response to Amendments
Claim Objections
In light of the amendment of claims 3, 6, 9, and 12, the objections to these claims are withdrawn.
Rejection of claims under 35 USC § 112(b)
In light of the amendment of claims 15 and 25 and Applicant’s arguments (Pages 6-9, filed 1/15/26) regarding claim 14, the rejection of claims 14, 15, and 25 under 35 USC § 112(b) as being indefinite is withdrawn.
Notice for all US Patent Applications filed on or after March 16, 2013
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 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.
Maintained Rejections
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.
Claims 1, 3-6, 8-16, and 18-25 are again rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (US 2018/0169024 A1 – “Lee”).
The claimed invention is a composition, comprising:
a plurality of mechanically-activated microcapsules (MAMCs);
a mechanically-activated microcapsule defining a shell and an exterior surface; and
the mechanically-activated microcapsule comprising one or more adhesion groups disposed on the exterior surface of the mechanically-activated microcapsule,
the one or more adhesion groups configured to covalently interact with a matrix material upon contact with the matrix material so as to adhere the mechanically-activated microcapsule to the matrix material.
Lee teaches a mechanically-activated microcapsules (MAMCs) for drug delivery to a region of a subject’s body, wherein the MAMCs have one or more rupture profiles that enable the mechanically-activated microcapsules to rupture in response to one or more mechanical loads in said region of the subject's body (Abstract, [0049], claims 21-26). The MAMCs comprise hollow microcapsules that encapsulate one or more active ingredients inside a solid shell, and the solid shell comprises one or more polymers (i.e., the shell is a “polymer shell”); preferably, the shell comprises poly(lactic-co-glycolic)acid (PLGA) ([0034]). The rupture profile of the MAMCs can be adjusted by modifying the physical properties of the matrix, thereby modifying the adhesion of the MAMCs to the matrix ([0052]). Modifying the nature of adhesive interaction (e.g., electrostatic vs. protein-ligand interactions) can influence rupture ([0052]). The adhesion properties of the MAMCs can be tuned by covalently bonding microcapsules to the hydrogel upon photopolymerization ([0052]). Alternatively, adhesion can be controlled using electrostatic interactions where either the shell or hydrogel is modified with a surface charge ([0052]).
Regarding instant claim 1, the limitation of a composition comprising a plurality of mechanically-activated microcapsules is anticipated by the MAMCs for drug delivery to a region of a subject’s body (Abstract, [0049], claims 21-26), as taught by Lee.
Regarding instant claim 1, the limitation of an MAMC defining a shell and an exterior surface is anticipated by the MAMCs which comprise hollow microcapsules that encapsulate one or more active ingredients inside a solid shell ([0034]), as taught by Lee.
Regarding instant claim 1, the limitations of the MAMC comprising one or more adhesion groups disposed on the exterior surface of the MAMC, the one or more adhesion groups configured to covalently interact with a matrix material upon contact with the matrix material so as to adhere the mechanically-activated microcapsule to the matrix material are anticipated by the adhesion properties of the MAMCs which can be tuned by covalently bonding microcapsules to the hydrogel ([0052]), and the cross-linkable surfactant (e.g., pluronic diacrylate) ([0079]), as taught by Lee.
Regarding instant claims 3 and 4, the limitations of the MAMC being biodegradable, and comprising PLGA, respectively, are anticipated by the MAMCs which comprise a shell of the biodegradable polymer PLGA ([0034] and [0062]), as taught by Lee.
Regarding instant claims 5 and 6, the limitations of a material enclosed within the shell of the MAMC and an anti-inflammatory, respectively, are anticipated by the active ingredient(s) which are preferably suspended in an aqueous phase that is completely surrounded by the solid shell, wherein the active ingredient includes one or more anti-inflammatory compounds ([0036]), as taught by Lee.
Regarding instant claim 8, the limitation of the shell defining a thickness in the range of from about 0.05 µm to about 30 µm is anticipated by the shells of the MAMCs having a thickness of between about 0.05 µm and 30 µm ([0038]), as taught by Lee.
Regarding instant claim 9, the limitation of the MAMC defining a diameter of from about 0.5 µm to about 300 µm is anticipated by the MAMCs having a diameter ranging from about 0.5 µm to about 300 µm ([0038]), as taught by Lee.
Regarding instant claim 10, the limitations of an injectable formulation and carrier are anticipated by the MAMCs which are injected into a subject’s joint ([0050], [0054]) and the pharmaceutically acceptable carrier ([0053]), as taught by Lee.
Regarding instant claim 11, the limitation of a selected tissue of the subject is anticipated by the MAMCs which provide a platform for stimulating biological regeneration and repair in mechanically-loaded tissues of a subject's body (e.g., musculoskeletal tissues, cartilage tissue, etc.) ([0032]), as taught by Lee.
Regarding instant claims 12 and 13, the limitations of the selected tissue being in a disease state, and inflammation, respectively, are anticipated by the tissue damage, tissue breakdown, or tissue inflammation, such as cartilage legions, cartilage injury, or cartilage breakdown within a joint, or one or more symptoms thereof ([0037] and [0087]), as taught by Lee.
Regarding instant claim 14, the limitation of the adhesion groups configured to adhere preferentially to the selected tissue is anticipated by the cell adhesion and matrix deposition on a positively charged shell for strong matrix adhesion ([0079]), as taught by Lee.
Regarding instant claim 15, the limitation of a method for delivering MMACs to a subject comprising injecting an injectable formulation into a subject is anticipated by the MAMCs which are injected into a subject’s joint ([0050], [0054]), as taught by Lee.
Regarding instant claim 16, the limitation of an article comprising a matrix material is anticipated by the MAMCs embedded within a matrix material which is a gel and/or engineered tissue for cartilage repair/replacement ([0050]), as taught by Lee. The limitations of the composition and covalent interaction of the adhesion group with the matrix material of claim 1 are discussed in detail above.
Regarding instant claim 18, the limitation of the matrix material which is a hydrogel is anticipated by the matrix which is a hydrogel ([0053]), as taught by Lee.
Regarding instant claims 19-22, the limitations of the tensile strain to the article are anticipated by the MAMCs which have one or more rupture profiles that enable the mechanically-activated microcapsules to rupture in response to one or more mechanical loads in said region of the subject's body (Abstract, [0049], claims 21-26), as taught by Lee since these are properties associated with the composition comprising the MAMCs and inseparable from it. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the composition, then the properties are also taught by the prior art. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990.) See MPEP 2112.01. The burden is shifted to Applicant to show that the prior art product does not possess or render obvious the same properties as the instantly claimed product. Furthermore, the recited limitations are future intended effects after the claimed article is applied to a subject’s body.
Regarding instant claim 23, the limitation of the article configured for exterior application to a subject is anticipated by the MAMCs delivered to a region of the body that is not a joint, such as skin ([0043]), as taught by Lee.
Regarding instant claim 24, the limitation of the article configured for implantation into a subject is anticipated by the microcapsules which are embedded into a subject’s joint or other tissue ([0042]), and the matrix material which is implanted surgically into a joint ([0050]-[0051]), as taught by Lee.
Regarding instant claim 25, the limitation of treating a subject is anticipated by the treatment of tissue damage, tissue breakdown, or tissue inflammation, such as cartilage legions, cartilage injury, or cartilage breakdown within a joint, or one or more symptoms thereof in a subject ([0037] and [0087]), as taught by Lee.
Response to Arguments
Applicant’s arguments (Pages 7-8, filed 01/15/26) with respect to the rejection of claims 1, 3-6, 8-16, and 18-25 under 35 U.S.C. 102(a)(1) as being anticipated by Lee have been fully considered but are not persuasive.
Applicant argues that the office does not identify disclosure in Lee that teaches every feature of claim 1 as those features are arranged in the claim, in particular the feature of "[a] mechanically activated microcapsule comprising one or more adhesion groups disposed on the exterior surface of the mechanically-activated microcapsule, the one or more adhesion groups configured to covalently interact with a matrix material upon contact with the matrix material so as to adhere the mechanically-activated microcapsule to the matrix material."
This is not persuasive because the limitations of the MAMC comprising one or more adhesion groups disposed on the exterior surface of the MAMC, the one or more adhesion groups configured to covalently interact with a matrix material upon contact with the matrix material so as to adhere the mechanically-activated microcapsule to the matrix material are anticipated by the adhesion properties of the MAMCs which can be tuned by covalently bonding microcapsules to the hydrogel ([0052]), as taught by Lee.
Each of the claimed features or components in the same arrangement are taught by the prior art, as explained in detail for each component and claim above. The claimed limitations of the one or more adhesion groups disposed on the exterior surface of the MAMC, the one or more adhesion groups configured to covalently interact with a matrix material upon contact with the matrix material so as to adhere the mechanically-activated microcapsule to the matrix material are anticipated by the adhesion properties of the MAMCs which can be tuned by covalently bonding microcapsules to the hydrogel ([0052]), and the cross-linkable surfactant (e.g., pluronic diacrylate) ([0079]), as taught by Lee. The covalent interaction and adhesion of MAMCs to the matrix is clearly taught by Lee ([0052]).
Since the same components, in the same arrangement, in the same composition, and having the same properties of covalent interaction and adhesion of MAMCs to the matrix, are taught by the prior art, the claimed composition is anticipated.
Therefore, the rejection of 10/21/25 is maintained.
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.
Claims 2, 7, and 17 are again rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2018/0169024 A1 – “Lee”), as applied to claims 1, 3-6, 8-16, and 18-25 above, in view of Yang et al. (Int J Nanomedicine 2018 Apr 12;13:2217-2263 – “Yang”) as evidenced by PubChem (Catechol | C6H6O2 | CID 289 - PubChem- pp. 1-133 downloaded 10/17/2025 – “PubChem”).
Instant claim 2 is drawn to the composition of claim 1, wherein the one or more adhesion groups comprise a 1,2-dihydrobenzene group.
The teaching of Lee is discussed above.
Lee does not expressly teach the one or more adhesion groups comprise a 1,2-dihydrobenzene group.
Yang teaches that biomimetic material has a strong potential for antibacterial tissue adhesives and biomaterial coatings because of the material independent adhesive properties of catechols (Page 2221, Col. 2, ¶ 1).
PubChem discloses that a synonym for catechol is 1,2-dihydroxybenzene (Page 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare MAMCs for drug delivery to a region of a subject’s body, wherein adhesion groups such as a cross-linkable surfactant (e.g., pluronic diacrylate) is used, as taught by Lee, in view of the biomimetic material which has a strong potential for antibacterial tissue adhesives and biomaterial coatings because of the material independent adhesive properties of catechols, as taught by Yang, wherein catechol is also known as 1,2-dihydroxybenze, as evidenced by PubChem, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because of the advantage of the material-independent adhesive properties of catechols (Page 2221, Col. 2, ¶ 1), as taught by Yang.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claim 2, the limitation of the 1,2-dihydroxybenze group would have been obvious over the catechols (Page 2221, Col. 2, ¶ 1), as taught by Yang, wherein a synonym for catechol is 1,2-dihydroxybenzene (Page 2), as evidenced by PubChem.
Regarding instant claim 7, the limitation of the material comprising an antibiotic would have been obvious over the amoxicillin antibiotic loaded hydrogels which facilitates drug effects specifically at the site of infection (Page 2237, ¶ bridging Col. 1 and 2), as taught by Yang.
Regarding instant claim 17, the limitation of the matrix material which is a fibrous material would have been obvious over the nanofibrous webs (Page 2225 – Col. 2 of the Table), as taught by Yang.
Response to Arguments
Applicant’s arguments (Pages 8-9, filed 01/15/26) with respect to the rejection of claims 2, 7, and 17 under 35 U.S.C. 103 as being unpatentable over Lee in view of Yang, as evidenced by PubChem have been fully considered but are not persuasive.
Applicant argues that the office does not identify disclosure in the cited art that teaches every feature of independent claim 1, and the office does not identify disclosure in Yang and PubChem which establishes that a person of ordinary skill in the art who reads the cited art would then be motivated to modify the cited art in all the ways necessary to arrive at dependent claims 2, 7, and 17.
This is not persuasive because, as explained above, each of the features or components recited in claim 1, in the same composition and the same arrangement, are taught by the prior art. The limitations of the MAMC comprising one or more adhesion groups disposed on the exterior surface of the MAMC, the one or more adhesion groups configured to covalently interact with a matrix material upon contact with the matrix material so as to adhere the mechanically-activated microcapsule to the matrix material are anticipated by the adhesion properties of the MAMCs which can be tuned by covalently bonding microcapsules to the hydrogel ([0052]), as taught by Lee.
The deficiency in Lee regarding the one or more adhesion groups comprise a 1,2-dihydrobenzene group is cured by Yang, as evidence by PubChem. One of ordinary skill in the art would have found it obvious to use the biomimetic material which has a strong potential for antibacterial tissue adhesives and biomaterial coatings because of the material independent adhesive properties of catechols, as taught by Yang, in the composition of Lee. The combination of references is proper because of the advantage of the material-independent adhesive properties of catechols (Page 2221, Col. 2, ¶ 1), as taught by Yang.
Since all the claimed limitations are taught and rendered obvious by the cited prior art, the obviousness rejection of 10/21/25 is maintained.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-6, 10-13, 15-16, 18-22, and 24-25 are again rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-11, 14, and 16 of U.S. Patent No. 12,251,476 B2 (“the ‘476 Patent”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a composition comprising a plurality of MAMCs and methods of treating a subject by injecting into a subject an injectable formulation comprising the MAMCs, and therefore, encompass overlapping or coextensive subject matter.
The difference is that claim 1 of the ‘476 Patent recites that the population of MAMCs has one or more rupture profiles, whereas instant claims are silent regarding this limitation.
However, the one or more rupture profiles of the MAMCs are properties associated with the MAMCs and inseparable from them. Therefore, since instant claims recite the same composition of MAMCs, the same rupture profiles would be present and would be expected.
Therefore, instant claims are obvious over claims of the ‘476 Patent and they are not patentably distinct over each other.
Claims 1, 3-6, 10-13, 15-16, 18-22, and 24-25 are again provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-3, 5, 7-17, and 19-20 of copending Application No. 19/074,541 (“the ‘541 Application”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a composition comprising a plurality of MAMCs and methods of treating a subject by injecting into a subject an injectable formulation comprising the MAMCs, and therefore, encompass overlapping or coextensive subject matter.
The difference is that claim 1 of the ‘541 Application recites that the population of MAMCs has one or more rupture profiles, whereas instant claims are silent regarding this limitation. However, the one or more rupture profiles of the MAMCs are properties associated with the MAMCs and inseparable from them. Therefore, since instant claims recite the same composition of MAMCs, the same rupture profiles would be present and would be expected.
Therefore, instant claims are obvious over claims of the ‘541 Application and they are not patentably distinct over each other.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Response to Arguments
Applicant’s arguments (Page 9, filed 01/15/26) with respect to the rejection of claims 1, 3-6, 10-13, 15-16, 18-22, and 24-25 on the ground of nonstatutory double patenting (NSDP) as being unpatentable over claims 1, 6-11, 14, and 16 of “the ‘476 Patent; and the provisional rejection of claims 1, 3-6, 10-13, 15-16, 18-22, and 24-25 on the ground of NSDP as being unpatentable over claims 1-3, 5, 7-17, and 19-20 of “the ‘541 Application have been fully considered but are not persuasive.
Applicant argues that because the pending claims are patentably distinct from the foregoing patent and patent application, these rejections are premature and should be withdrawn.
This is not persuasive because although the conflicting claims are not identical, they are not patentably distinct from each other and encompass overlapping or coextensive subject matter, as explained in detail above. Applicant has not specifically pointed out the deficiencies in the NSDP rejections above.
Until such time that amendments are made to distinguish over the conflicting claims or terminal disclaimers are filed, the NSDP rejections of 10/21/25 will be maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 extension fee 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 ARADHANA SASAN whose telephone number is (571)272-9022. The examiner can normally be reached Monday to Friday from 6:30 am to 3:00 pm.
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, Robert A. Wax can be reached on 571-272-6023. 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.
/ARADHANA SASAN/Primary Examiner, Art Unit 1615
Prosecution Insights