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 .
Status of the Claims
Claims 1 and 3 have been amended. Claims 6-10, 12, 15, 16, 22-24 and 30-33 are cancelled. No claims are newly added. Accordingly, claims 1-5, 11, 13, 14, 17-21 and 25-29 remain pending in the application.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-5, 11, 13, 14 and 17-21) in the reply filed on 3/3/2026 is acknowledged.
Claims 25-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Accordingly, claims 1-5, 11, 13, 14 and 17-21 are currently under examination.
Claim Objections
Claim 11 is objected to because of the following informalities: the claim is missing a comma at the end of line 4. Appropriate correction is requested.
Claim Rejections - 35 USC § 112
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.
Claim 3 is 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 3 recites, “matrix of covalently or ionically crosslinked polymer compounds selected from the group consisting of functionalized hyaluronic acid, thiolated polyethylene glycol dithiol maleimide, diacrylated polyethylene glycol polyethylene diacrylate, and polyethylene vinyl sulfone”. The instant specification states, “Fig. 4 provides a few examples of microparticles made from thiolated hyaluronic acid (ThHA), polyethylene glycol dithiol maleimide, (PEG-Thiol Mal), diacrylate polyethylene glycol polyethylene diacrylate (PEGDA), alginate, polyethylene vinyl sulfone, and acrylated hyaluronic acid (AHA)” (page 19, lines 18-21). However, Fig. 4 demonstrates said various microparticles and names PEG vinyl sulfone. Thus, the disclosure contradicts itself as to which compound, polyethylene vinyl sulfone or polyethylene glycol vinyl sulfone is being referred to and, as such, it is unclear for which compound the inventor had possession.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3 and 11 are rejected 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.
Claim 3 recites, “matrix of covalently or ionically crosslinked polymer compounds selected from the group consisting of functionalized hyaluronic acid, thiolated polyethylene glycol dithiol maleimide, diacrylated polyethylene glycol polyethylene diacrylate, and polyethylene vinyl sulfone”. The instant specification states, “Fig. 4 provides a few examples of microparticles made from thiolated hyaluronic acid (ThHA), polyethylene glycol dithiol maleimide, (PEG-Thiol Mal), diacrylate polyethylene glycol polyethylene diacrylate (PEGDA), alginate, polyethylene vinyl sulfone, and acrylated hyaluronic acid (AHA)” (page 19, lines 18-21). However, Fig. 4 demonstrates said various microparticles and names PEG vinyl sulfone. Thus, the disclosure contradicts itself as to which compound, polyethylene vinyl sulfone or polyethylene glycol vinyl sulfone is being referred to. Accordingly, the claim is indefinite because it is unclear as to whether “polyethylene vinyl sulfone” refers to polyethylene vinyl sulfone or polyethylene glycol vinyl sulfone.
Claim 11 recites, “wherein said hydrogel microparticles are: injected into an intraarticular space of a joint, introduced into a synovial capsule portion of said joint, introduced subdermally as a dermal filler[,] introduced between organs of said subject”. The claim is indefinite because it is unclear whether each option listed is required in combination or in the alternative. After review of the instant specification, it appears that the options are intended to be in the alternative. As such, it is suggested that “or” is added at the end of line 5 of the claim. For art purposes, the claim is being given its broadest and most reasonable interpretation and, that is, one of the options listed is required to meet the claim.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 11 and 17-21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ott et al. (WO 2020/247776 A1, eff. filing date July 6, 2019, hereafter as “Ott”).
The applied reference has a common inventor/assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
The claimed invention is drawn to method for viscosupplementation in a joint or surgical site of a human or animal subject, said method comprising: introducing into the joint or surgical site a plurality of porous viscoelastic solid hydrogel microparticles each having a smooth outer surface and a size of greater than about 100 microns, and substantially free of any cells, tissue, or therapeutic compounds. It is noted that the term "substantially free," is defined in the instant specification as the ingredient is not intentionally added to the composition, although incidental impurities may occur, or residual/trace amounts may be left behind from the manufacturing process. In such embodiments, the hydrogel precursor solution compositions comprise less than about 0.05% by weight, preferably less than about 0.01%, and more preferably about 0% by weight of such an ingredient, based upon the total weight of the solution taken as 100% by weight. See page 12, 1st paragraph.
Regarding instant claims 1 and 3, Ott teaches hydrogel microparticles comprising a 3-dimensional matrix of covalently crosslinked polymer compounds such as functionalized hyaluronic acid, polyethylene glycol vinyl sulfone, polyethylene glycol maleimide (PEGMAL), polyethylene glycol diacrylate (PEGDA), and functionalized varieties of the same (e.g., acrylated, methacrylated, thiolated, etc.) (page 1, last paragraph; page 8, last paragraph; Example 7). Ott teach an embodiment using empty microparticles for joint lubrication and/or viscosupplementation by implanting a plurality of empty microparticles in a joint (page 2, last paragraph; page 17, 2nd paragraph; claim 66). Ott demonstrates that the microparticles have a smooth outer surface (Figure 3B; page 3, lines 11-12). Ott also teaches that the microparticles have a size greater than about 30 microns and in some cases greater than 300 microns, preferably ranging from about 50 microns to about 1.5 mm, more preferably from about 150 microns to about 1.5 mm, even more preferably from about 300 microns to about 1.4 mm (page 13, 2nd paragraph). Otto further teaches that the hydrogel particles are porous (interstitial spaces or pores; page 8, lines 13-17).
Regarding instant claims 2 and 19, Ott teaches the elements discussed above. Ott also teaches direct injection of the microparticle composition at or near the site of inflammation, injury, arthritis, degeneration, etc. (page 16, lines 17-19).
Regarding instant claim 4, Ott teaches the elements discussed above. Ott also teaches that the compositions can include a mixture of different microparticles, for example, a mixture of degradable and durable hydrogel microparticles, and/or a mixture of different sized microparticles (page 2, lines 13-15).
Regarding instant claim 5, Ott teaches the elements discussed above. Ott also teaches that the microparticles demonstrate no induction of any inflammatory response at the site of implantation (page 17, lines 29-30). Ott teaches microparticles can be administered as part of a joint lubricant treatment which implies friction reduction (page 17, lines 20-23).
Regarding instant claim 11, Ott teaches the elements discussed above. Ott also teaches injecting microparticles into the articular capsule of a Sprague-Dawley rat knee joint (page 41, lines 5-9; Fig. 20).
Regarding instant claim 17, Ott teaches the elements discussed above. Ott also teaches that the microparticles are suspended or dispersed in a suitable delivery vehicle for administration to the subject (page 16, lines 8-9).
Regarding instant claim 18, Ott teaches the elements discussed above. Ott also teaches the particular delivery vehicles, viscous solutions, putties, pastes, gels, saline solutions or other buffered solutions (page 16, lines 9-15).
Regarding instant claim 20, Ott teaches the elements discussed above. Ott also teaches that the microparticles were delivered via syringe (injected) as a suspension in a phosphate buffered solution (page 41, line 15). Ott’s teaching implies that the syringe was loaded prior to use (i.e., pre-loaded).
Regarding instant claim 21, Ott teaches the elements discussed above. Ott also teaches that microparticles remained where initially implanted in the knee joint after a period of time of 14 days (page 4, lines 24-27; page 41, 3rd paragraph – page 42, line 1; Fig. 20).
Thus, the teachings of Ott render the instant claims anticipated.
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.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being obvious over Ott et al. (WO 2020/247776 A1, eff. filing date July 6, 2019, hereafter as “Ott”), as applied to claim 1 above, in view of Gravett et al. (WO 2019/046834 A1, Mar. 7, 2019, hereafter as “Gravett”).
The applied reference (Ott) has a common inventor/assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
The claimed invention is described above.
Ott teaches the elements discussed above.
Ott is silent to introducing the microparticles in and/or around a site of implantation of a surgical device (instant claim 13), wherein the surgical device is surgical mesh (instant claim 14).
Gravett teaches injecting hydrogel particles into a joint to relieve pain providing viscosupplementation ([0191]). Gravett also teaches applying the composition to tissue to reduce the coefficient of friction, coating a device to lubricate the passage of the device, coating medical devices such as surgical mesh with said hydrogel composition ([0265]).
The references are both drawn to hydrogel microparticles for joint viscosupplementation, thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to introduce hydrogel microparticles in and/or around a site of implantation of a surgical device (i.e., coating on a device) such as a surgical mesh, as suggested by Gravett, into the invention of Ott with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Gravett teaches that the hydrogel composition can be in the form of microparticles and can also be used in connection with a medical device such as a surgical mesh to effectively lubricate the surrounding tissue and, thereby, reduce the coefficient of friction between the device and surrounding tissue.
Thus, the combined teachings of Ott and Gravett render the instant claims prima facie obvious.
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 1-5, 11 and 17-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-10, 3-16, 22-31 of copending Application No. 18/717569 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the instant claims and the subject matter of the copending claims significantly overlap.
The claimed invention is drawn to method for viscosupplementation in a joint or surgical site of a human or animal subject, said method comprising: introducing into the joint or surgical site a plurality of porous viscoelastic solid hydrogel microparticles each having a smooth outer surface and a size of greater than about 100 microns, and substantially free of any cells, tissue, or therapeutic compounds. Instant claim 11 further recites, “wherein said hydrogel microparticles are... introduced subdermally as a dermal filler”.
Copending invention is drawn to a method for aesthetic or cosmetic soft tissue filling in a human subject, said method comprising placing into a site of implantation in a subject in need thereof, a suspension comprising a plurality of porous viscoelastic solid hydrogel microparticles dispersed in a carrier vehicle, wherein each microparticle is a self-sustaining body having an outer surface and a defined/discrete 3-dimensional shape and geometry, wherein said microparticles are substantially free of any cells, tissue, or therapeutic compounds; and a kit thereof. The copending claims further recite, “sub-dermal” (claim 2), “implantation via injection” (claim 3), “particles... having a 3-dimensional matrix covalently or ionically crosslinked polymer compounds” (claim 6), “hyaluronic acid, polyethylene glycol, ... and functionalized varieties of the same” (claim 7), “particle size of greater than 30 µm and less than 2 mm” (claim 9), “induce a favorable response” (claim 10), “two different populations of microparticles” (claim 15), and “wherein said delivery vehicle is a buffered saline solution, viscous solution, putty, paste, or gel” (claim 16).
The copending claims do not explicitly recite that the hydrogel microparticles have a “smooth outer surface”, however the Figures of the copending application demonstrate that the microparticles have a smooth outer surface. “Products of identical chemical composition cannot have mutually exclusive properties” (MPEP 2112.01(II)).
The copending claims do not explicitly recite, a particle size of greater than about 100 microns.
MPEP 244.05 states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Because the claimed range greater than about 100 microns overlaps with the range of greater than 30 µm and less than 2 mm disclosed by the copending application, a prima facie case of obviousness exists. Further, it would have been prima facie obvious to one of ordinary skill in the art to optimize the particle size by way of routine experimentation with a reasonable expectation of success because the copending application discloses a range of greater than 30 µm and less than 2 mm and it is the normal desire of scientists or artisans to improve upon what is already generally known including determining where in a disclosed range is the optimum values.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Thus, the subject matter of the instant claims are unpatentable over the subject matter of the copending application ‘569.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY HAGOPIAN whose telephone number is (571)272-6097. The examiner can normally be reached on M-F 9:00 am - 5:00 pm.
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/CASEY S HAGOPIAN/Examiner, Art Unit 1617