DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
Acknowledgement is made of the response filed on May 5, 2026. In that response, claims 31-34, 36, 38, 39, 41, and 44 were amended and claim 48 was cancelled. Claims 31-47 and 49-51 are treated on the merits in this action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Listing
Applicant is requested to accurately mark claim amendments. See MPEP §714(II)(C). Claim 31 for example contains inaccurate claim amendment markings. Any inaccurate claim status identifiers and/or claim markings will not prejudice any Office action issuing thereon from being made final.
Claim Objections
Claim 31 is objected to because of the following informalities: inconsistent line indentations in the last two lines.
Claim 39 is objected to because of the following informalities: “p-Azidobenzoyl Hydrazide”, “…Azido-2…”, “…Succinimidyl”, and “…Azidosalicylamido…” should be in lowercase.
Appropriate corrections are required.
Claim Rejections - 35 USC § 112
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 31-47 and 49 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.
The term “about” in claim 31 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The disclosure does not define or otherwise indicate the extent of “about”, e.g., +/- some percentage. “About 7 parts” and “about 7.5 parts” are recited, which indicate that they cover different ranges, but it does not aid in understanding “about” as the ranges, though different, could overlap. Therefore the public would not be apprised of the scope of claim 31. None of the dependent claims 32-47 and 49 resolves this issue and therefore they are also rejected on this ground.
Response to Arguments
In the response filed May 5, 2026 Applicant did not present any argument regarding the above rejection, made identically but for claim 48 (now cancelled and its limitations incorporated into claim 31).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 31-42, 45-47, and 49-51 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Masters (US 2006/0073207 A1 published on April 6, 2006) in view of Trieu (US 7731981, divisional of 10/704167 filed on November 7, 2003), as evidenced by Pike (US 7141545 filed on July 19, 2002) and Goldenheim (US 6451335 issued on September 17, 2002).
Masters concerns protein biocoacervates and methods of making and using the same (Title; abstract). Regarding claims 31, 39, and 45, Masters discloses methods of administering “protein biocoacervates and biomaterials” (abstract) including particle embodiments (Fig.4A, 4B, 5, and accompanying text) to a patient (claims 29-43). The target sites include joints and space surrounding joints, such as to administer anti-rheumatoid agents (paras.0177, 0198, 0081).
The protein coacervates or biocoacervates are precipitated from a biocompatible solvent system comprising a primary protein, including Type I collagen (para.0044), elastin (Example 1, para.0218; see paras. 0011,; Fig.15), and heparin as the glycosaminoglycan (Example 1, para.0218; see paras.0011, 0020-21, 0032; Figs.4A, 4B). The primary proteins are soluble and biocompatible (para.0041). Masters discloses using crosslinking agents such as glutaraldehyde, p-Azidobenzoyl hydrazide and the others recited in claim 39 (para.0154). The protein biocoacervates are at least partially produced from a “shape-holding amorphous solid” precipitate (para.0158), thermoplastic (para.0037), and are formed into particles (paras.0154, 0164-75).
Regarding the ratio in claims 31, 50, and 51, Example V here appears verbatim as Example 1 in Masters (para.0218), with a ratio of 7.5 parts of Type I collagen to 2 parts of elastin to 1 part of heparin. 7.5 parts is close to 7 parts in claim 50. A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties, i.e., regenerate tissue, repair tissue, replace tissue, and deliver local and systemic therapeutic effects, as Masters’s particles. MPEP § 2144.05(I) (citations omitted).
“[T]he biocoacervates and biomaterials of the present invention may be injected, implanted,… to regenerate tissue, repair tissue, replace tissue, and deliver local and systemic therapeutic effects… or alternatively, may be used to treat specific conditions, such as… bone defects and trauma, ligament defects and trauma, cartilage defects and trauma…” (para.0159 (emphases added); see also Examples 1-3, paras.0218-20; see paras.0169-70). Ligaments and cartilage make up a joint.
Regarding claim 32 Masters discloses particles comprising collagen, elastin, and heparin, and teaches the others recited (Figure 15, paras.0032, 0044),
Regarding claims 33 and 42, Masters discloses using water, dimethyl sulfoxide, ethanol, and other biocompatible solvents (paras.0011, 0053, 0137).
Regarding claims 34-36, Masters discloses that the biocoacervates could comprise analgesics (para.0068), anti-inflammatory agents (paras.0054, 0080), and anticoagulants (para.0014) among others.
Regarding claims 37 and 38, Masters discloses incorporation of biocompatible additives such as polyurethanes, nylons, silicones, and the others recited (paras.0141, 0219 Example 2).
Regarding claims 40, Masters teaches biocoacervates prepared from and comprising collagen, elastin, heparin, and water (Example 1, para.0218). Thus the biocoacervates of Example 1 would have an affinity to align and adjoin with the periosteum as recited in claim 40. Furthermore a clause that “simply expresses the intended result of a process step positively recited” in a method claim is not given weight. MPEP §2111.04(I)(citations omitted). Here, the “particles align with a periosteum of the joint and adjoin together, thereby providing a cushion” is not performed actively, i.e., as a step comprising the method claimed. Rather it would occur as the particles of claim 31, which Masters teaches, are administered as recited. Thus the clause raises a question as to the limiting effect of the claim language. Such a clause “in a method claim is not given weight when it simply expresses the intended result of a process step positively recited”, as in the instant claim. MPEP § 2111.04 (citations omitted).
Regarding claim 41, Masters expressly teaches “combining primary proteins such as collagen,… and one or more glycosaminoglycans such as ….” those in claim 41 (para.0011; see also para.0052).
Regarding claim 45, Masters teaches treating joints in the fingers, wrists, etc., without also disclosing their volume (para.0198).
Regarding claim 49, the particles are preferably 1-1000 µm (para. 0167), e.g., 1000 µm. Example 3 discloses ground particles that filter through a 150 µm screen (para. 0220).
Masters does not disclose administering its protein coacervates in particle form into the “area proximal to the periosteum of a the joint” as in claims 31, “implanting into a joint capsule of the synovial joint at least one free-floating joint cushion to augment synovial fluid in the synovial space”, precisely as phrased in claim 47, or “ratio of 7 parts of Type I collagen to 2 parts of elastin to 1 part of the one or more glycosaminoglycans” in claim 50.
Trieu however teaches “method of treating a synovial joint” by injecting particles of collagen-based material into the synovial space (title; abstract; col.4 ll.8-20; Figs.1C-1D). Specifically, the “collagen-based material is ‘surgically added’ to the synovial joint”, i.e., “the material is added by the intervention of a medical personnel, ... [which] preferably includes injection through a hypodermic needle, although other surgical methods of introducing the collagen-based material into the joint may be used” (col.4 ll.8-20). Trieu teaches administering a gel or suspension of the particles, wherein the “particle size can be in the range from 0.01 mm to 5 mm, preferably between 0.05 and 0.25 mm” (Examples 1-2, col.5 ll.14-42). The range of 10 - 5000 µm overlaps and the preferred 50 - 250 µm lies within the range in instant claim 12. Figure 1C is shown below.
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It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of Masters with that of Trieu and administer the protein coacervates or biocoacervates of Masters into the synovial space or the area proximal to the periosteum as described by Trieu and recited in the instant claims. The skilled person would have been motivated to do so because (a) Masters teaches (i) forming the biocoacervate particles into injectable compositions (Examples 1-3, paras.0218-20), and (ii) that the biocoacervate particles accommodate and assist in the repair of a wound by forming into joints such as of the finger, toe, knee, hip, elbow, or wrist (para.0198), and (b) Trieu teaches that collagen-based particles, i.e. protein-based particles, can be administered into the synovial space to promote healing and/or proper joint function (abstract), and furthermore teaches as follows.
Benefits and advantages arising from use of the materials and methods of the present invention include the following:
(1) the invention provides lubrication and/or cushioning to degenerated synovial joints, improving or restoring proper joint function;
(2) the rehydration provided by the invention is expected to slow the degenerative process;
(3) the invention relieves pain due to improved lubrication of the joint;
(4) the procedure is percutaneous or a minimally invasive outpatient procedure;
(5) the risks are minimal, as similar techniques and materials are used in cosmetic procedures;
(6) the materials are biocompatible since natural or human-recombinant collagen-based materials are used[.]
(Trieu, col.4 ll.51-65; emphases added).
Although Trieu does not disclose any clinical results, one of ordinary skill in the art at the time of the invention would have known of successfully injecting biocompatible protein particles as evidenced by Pike and Goldenheim. Pike discloses intra-articular injection of sustained release, degradable and nondegradable microcapsules (col.9 ll.46-col. 10 1.2), gelatin microcapsules, methacrylate coacervate microcapsules, and albumin microspheres (col.5 ll.1-5; col.10 ll.2-5) comprising insulin-like growth factor (IGF-I) to treat articular cartilage disorders (title; abstract). “Suitable carriers for this invention are those conventionally used large stable macromolecules such as albumin, gelatin, collagen, ...” (col.8 ll.24-36). Thus Pike evidences that polymeric, coacervate, microcapsules comprising gelatin, albumin, and even collagen, are suitable for intra-articular injection.
Still further, Goldenheim evidences successful administration of biodegradable and biocompatible polymeric microspheres comprising an anti-inflammatory (dexamethasone) and an anesthetic (bupivacaine) into the knee joints of male baboons, “to confirm that the EDLA [extended duration local anesthetic] in the form of microparticles does not cause mechanical damage when administered to joint spaces that are freely exercising” (col.31 ll.33-35; see Example 16, col.31 1.9-col.33 1.57). ''Injection of EDLA microspheres into the knee joints of normal baboons resulted in no damage to articulating surfaces when assessed after three weeks” and the “EDLA particles were trapped in synovial membrane, with minimal foreign body reactions as a consequence” (col.33 ll.41-45). There was ''no evidence of inflammation, tenderness or altered range of motion on weekly physical examination of knees, in any animal” (col.32 ll.41-43). Also, observations for swelling, warmth, and discoloration all resulted in the negative (col.32 ll.62-63).
Claims 31-47 and 49-51 are rejected under 35 U.S.C. 103(a) as being unpatentable over Masters (US 2006/0073207 A1 published on April 6, 2006) in view of Trieu (US 7731981, divisional of 10/704167 filed on November 7, 2003), as evidenced by Pike (US 7141545 filed on July 19, 2002) and Goldenheim (US 6451335 issued on September 17, 2002) as applied to claims 31-42 and 45-51 above, and further in view of Ban (US 6,654,120 B2 issued on November 25, 2003).
Masters does not specifically teach the effective dose of the particles as recite din claims 43 and 44.
Ban discloses that the normal amount of synovial fluid in the knee cavity is less than 3.5 ml or 3.5 cc which is within the ranges in claims 37 and 38.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of Masters and Trieu with that of Ban and inject about 3.5 ml of the particles. The modification would have been prima facie obvious to one of ordinary skill because s/he would have wanted to administer a volume that the synovial space can accommodate, Ban discloses that for the knee cavity it is less than 3.5 ml, and thus it would have been appreciated that joints in the hip and finger would comprise a larger and lesser volumes respectively. One of ordinary skill in the art would have had to engage in no more than routine research and optimization to arrive at the appropriate volume to use for each joint area and for an individual patient, which supports obviousness. See MPEP § 2144.05.
Response to Arguments
Applicant's arguments filed May 5, 2026 have been fully considered but they are not persuasive. Applicant argues that “unpredictable response of joints to even ‘biocompatible’ particles render even a prima facie case of obviousness weak” as references and the Affidavits by Dr. DeVore (“the DeVore Affidavit”) and Dr. Sterns filed December 23, 2019 attests to (Remarks, 9-11, May 5, 2026.)
In response it is noted that as discussed in the parent case, U.S. Application Serial No. 12/344361, the references (Menzel, Kato, “Rheumatoid arthritis: A synovial disease?”) and the DeVore Affidavit concern collagen generally. In other words none addresses the biocoacervate claimed here. Also, none addresses Masters, which teaches the target sites of its biocoacervates, which the current claims read on, as joints and space surrounding joints, such as to administer anti-rheumatoid agents (paras.0177, 0198, 0081).
Further regarding the DeVore Affidavit, it is noted that no absolute, but reasonable, expectation of success is required for a determination of prima facie obviousness. MPEP § 2143.02. Here, it has been noted that Trieu teaches that collagen-based particles, i.e. protein-based particles, can be administered into the synovial space to promote healing and/or proper joint function (abstract), and furthermore benefits and advantages arising from use of the materials and methods of its invention includes:
(1) the invention provides lubrication and/or cushioning to degenerated synovial joints, improving or restoring proper joint function;
(2) the rehydration provided by the invention is expected to slow the degenerative process;
(3) the invention relieves pain due to improved lubrication of the joint;
(4) the procedure is percutaneous or a minimally invasive outpatient procedure;
(5) the risks are minimal, as similar techniques and materials are used in cosmetic procedures;
(6) the materials are biocompatible since natural or human-recombinant collagen-based materials are used[.]
(Trieu, col.4 ll.51-65; emphases added).
Dr. DeVore comments that Trieu does not disclose any specific type of collagen as “appropriate for introduction into a synovial joint”, and also fails to distinguish between the Types I and II of collagen “which have very different levels of biocompatibility wherein introduced into the joint or synovial space”, to conclude that “a doctor…working in collagen injections back around 2007 would find zero good examples of how particulate collagen materials would be used in practice”. (DeVore Affidavit, para.12, December 20, 2019.)
However the fact remains that before Applicant, Trieu had disclosed the concept of treating a synovial joint, by administering to the synovial joint a composition containing particulate collagen-based material, and the Office determines prima facie obviousness based on the combination of Masters and Trieu, not Trieu as standing alone. As noted above Masters teaches the particles as recited in the present claims, and method of using them (“may be administered, ..., injected and/or implanted ..., in the intracranial space, ..., next to the spinal cord....” (para.0160), and joints and space surrounding joints, such as to administer anti-rheumatoid agents (paras.0177, 0198, 0081)).
Furthermore as noted before Pike discloses intra-articular injection of sustained release, degradable and nondegradable microcapsules (col.9 ll.46-col. 10 1.2), gelatin microcapsules, methacrylate coacervate microcapsules, and albumin microspheres (col.5 ll.1-5; col.10 ll.2-5) comprising insulin-like growth factor (IGF-I) to treat articular cartilage disorders (title; abstract). “Suitable carriers for this invention are those conventionally used large stable macromolecules such as albumin, gelatin, collagen, ...” (col.8 ll.24-36). Thus Pike evidences that polymeric, coacervate, microcapsules comprising gelatin, albumin, and even collagen, are suitable for intra-articular injection. Goldenheim evidences successful administration of biocompatible polymeric microspheres comprising an anti-inflammatory (dexamethasone) and an anesthetic (bupivacaine) into the knee joints of male baboons, “to confirm that the EDLA [extended duration local anesthetic] in the form of microparticles does not cause mechanical damage when administered to joint spaces that are freely exercising” (col.31 ll.33-35; see Example 16, col.31 1.9-col.33 1.57). ''Injection of EDLA microspheres into the knee joints of normal baboons resulted in no damage to articulating surfaces when assessed after three weeks” and the “EDLA particles were trapped in synovial membrane, with minimal foreign body reactions as a consequence” (col.33 ll.41-45). There was ''no evidence of inflammation, tenderness or altered range of motion on weekly physical examination of knees, in any animal” (col.32 ll.41-43). Also, observations for swelling, warmth, and discoloration all resulted in the negative (col.32 ll.62-63).
Notably Dr. DeVore does not comment on the specifics teachings of Pike and Goldenheim which are public information.
Regarding Dr. Sterns’s affidavit, while it discusses the need for alternate treatment for improving joint function of animals, his initial skepticism of Kush® and subsequent impression of its efficacy, it does not appear to discuss how the Kush® product relates to the claims in this Application. Therefore the relevance of Dr. Sterns’s affidavit to the claims at hand is unclear.
Applicant next argues secondary indicia of non-obviousness, i.e., “surprising results and satisfaction of a long-felt unmet need achieved by the method of administering biocoacervate particles comprising Type I collagen into the ‘synovial space, an area proximal to the periosteum’”. (Remarks, 11-12, May 5, 2026.) Here Applicant relies on the Affidavits by Randall Meyers (“the Meyers Affidavit”) which “provides the ‘detailed information concerning the composition of Kush®’ in order to effectively apply the undisputed long-felt unmet need and surprising results to Applicant’s claims”. (Id.)
The Meyers Affidavit states that the Kush®, relabeled as SpryngTM, is made of the biocoacervate material produced using “at least 7 to 7.5 parts by weight of Type I collagen…, 2 parts by weight of elastin…, and 1 part by weight of heparin”. (Para. 4). However it is noted that Masters teaches in Example 1 biocoacervate material made using 1.5 g collagen, 0.4 g elastin, and 0.2 g heparin (Example 1, para.0218; see paras.0011, 0020-21, 0044; Figs.4A and 4B). Thus in Masters’s Example 1, the ratio is 7.5 collagen : 2 elastin : 1 heparin. (As noted above the present disclosure also contains this, identical example.) It is also noted that the Meyers Affidavit states “at least 7 to 7.5 parts by weight of Type I collagen…, 2 parts by weight of elastin…, and 1 part by weight of heparin”, which is not recited in the claims and does not appear supported in the disclosure.
Further regarding the Meyers Affidavit, it does not speak to the “undisputed long-felt unmet need and surprising results”, but to the Kush® (relabeled as SpryngTM), made of the biocoacervate material. The Kush® product is covered by US Patent no. 8153591 (Masters, Particles for Osteoarthritis Treatment: Injected Wet Particulate of Collagen-Elastin-Glycosaminoglycan Matrix into Synovial Fluid, Mechanically cushion Joint with Long duration, NPL cite 2, 05/31/2019 IDS). This patent (US 8153591) is the subject of the obviousness-type double patenting, for which Applicant has not submitted a terminal disclaimer or has otherwise overcome.
Applicant also relies on the Affidavit of Josh Wilhelm (“the Wilhelm Affidavit”) to argue that claim 31 is commensurate in scope with the secondary evidence of non-obviousness. (Remarks, 12.)
However in view of Masters’s express teaching of the same “historical ratio” of collagen Type I: elastin: heparin of 7.5: 2: 1, the protein content in the coacervate material, and forming shape-holding solid precipitate (para.0158), the issue of whether claim 31 is commensurate in scope with Kush®/SpryingTM products is premature at best. Furthermore the batched referred to in the Wilhelm Affidavit comprised heparin alone as the glycosaminoglycan.
Moreover, similar to the Meyers Affidavit, the Wilhelm Affidavit does not speak to the “undisputed long-felt unmet need and surprising results”, but to the Kush®product. As note above the Kush® product is covered by US Patent no. 8153591 (Masters, Particles for Osteoarthritis Treatment: Injected Wet Particulate of Collagen-Elastin-Glycosaminoglycan Matrix into Synovial Fluid, Mechanically cushion Joint with Long duration, NPL cite 2, 05/31/2019 IDS). This patent (US 8153591) is the subject of the obviousness-type double patenting, for which Applicant has not submitted a terminal disclaimer or has otherwise overcome.
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 31-47 and 49-51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11890371.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a method of treating or enhancing joint function comprising: administering a plurality of particles to a joint of a patient, comprising administering the plurality of particles in a location that is the synovial space, an area proximal to the periosteum, or both, wherein: the particles are at least partially produced from a shape- holding solid precipitate comprising at least one thermoplastic biocoacervate material precipitated from a solution comprising effective proportions of two or more soluble biocompatible proteins, one or more glycosaminoglycans and one or more biocompatible solvents to form the shape-holding solid precipitate, the two or more soluble biocompatible proteins comprise Type I collagen and elastin, the one or more glycosaminoglycans comprise heparin, and at least a portion of the particles are crosslinked with one or more crosslinking agents. The differences are that the ’371 patent’s claim 1 recites the limitations in present claims 48 and 49. Therefore the ‘371’s claims anticipate the present claims.
Claims 31-47 and 49-51 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 33-49 of US 8153591 in view of Trieu (US 7731981 issued on June 8, 2010) as evidenced by Pike (US 7141545 filed on July 19, 2002) and Goldenheim (US 6451335 issued on September 17, 2002).
Although the conflicting claims are not identical, they are not patentably distinct from each other. Both claim sets are drawn to methods comprising administering biocompatible material comprising a thermoplastic biocoacervate. The differences between the two claim sets include the ’591 patent’s claims reciting methods of delivering a pharmacologically active agent to a patient while the instant claims are drawn to treating or enhancing the function of a joint; however dependent claims here recite including pharmaceutical agents. The ’591 patent’s claims recite further detailed method of preparing the biocoacervates, which is narrower than here. However the biocoacervates in both claim sets are crosslinked and precipitated, and Trieu teaches injecting particles of collagen-based material into the synovial space (title; abstract; col.4 ll.8-20; Figs.1C-1D). Specifically, the “collagen-based material is ‘surgically added’ to the synovial joint”, i.e., “the material is added by the intervention of a medical personnel, ... [which] preferably includes injection through a hypodermic needle, although other surgical methods of introducing the collagen-based material into the joint may be used” (col.4 ll.8-20). Trieu teaches administering a gel or suspension of the particles, wherein the “particle size can be in the range from 0.01 mm to 5 mm, preferably between 0.05 and 0.25 mm” (Examples 1-2, col.5 ll.14-42). The range of 10 - 5000 µm overlaps and the preferred 50 - 250 µm lies within the range in instant claim 12. Figure 1C is shown below.
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It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of Masters with that of Trieu and administer the protein coacervates or biocoacervates of Masters into the synovial space or the area proximal to the periosteum as described by Trieu and recited in the instant claims. The skilled person would have been motivated to do so because (a) Masters teaches (i) forming the biocoacervate particles into injectable compositions (Examples 1-3, paras.0218-20), and (ii) that the biocoacervate particles accommodate and assist in the repair of a wound by forming into joints such as of the finger, toe, knee, hip, elbow, or wrist (para.0198), and (b) Trieu teaches that collagen-based particles, i.e. protein-based particles, can be administered into the synovial space to promote healing and/or proper joint function (abstract), and furthermore teaches as follows.
Benefits and advantages arising from use of the materials and methods of the present invention include the following:
(1) the invention provides lubrication and/or cushioning to degenerated synovial joints, improving or restoring proper joint function;
(2) the rehydration provided by the invention is expected to slow the degenerative process;
(3) the invention relieves pain due to improved lubrication of the joint;
(4) the procedure is percutaneous or a minimally invasive outpatient procedure;
(5) the risks are minimal, as similar techniques and materials are used in cosmetic procedures;
(6) the materials are biocompatible since natural or human-recombinant collagen-based materials are used[.]
(Trieu, col.4 ll.51-65; emphases added).
Although Trieu does not disclose any clinical results, one of ordinary skill in the art at the time of the invention would have known of successfully injecting biocompatible protein particles as evidenced by Pike and Goldenheim. Pike discloses intra-articular injection of sustained release, degradable and nondegradable microcapsules (col.9 ll.46-col. 10 1.2), gelatin microcapsules, methacrylate coacervate microcapsules, and albumin microspheres (col.5 ll.1-5; col.10 ll.2-5) comprising insulin-like growth factor (IGF-I) to treat articular cartilage disorders (title; abstract). “Suitable carriers for this invention are those conventionally used large stable macromolecules such as albumin, gelatin, collagen, ...” (col.8 ll.24-36). Thus Pike evidences that polymeric, coacervate, microcapsules comprising gelatin, albumin, and even collagen, are suitable for intra-articular injection.
Still further, Goldenheim evidences successful administration of biodegradable and biocompatible polymeric microspheres comprising an anti-inflammatory (dexamethasone) and an anesthetic (bupivacaine) into the knee joints of male baboons, “to confirm that the EDLA [extended duration local anesthetic] in the form of microparticles does not cause mechanical damage when administered to joint spaces that are freely exercising” (col.31 ll.33-35; see Example 16, col.31 1.9-col.33 1.57). ''Injection of EDLA microspheres into the knee joints of normal baboons resulted in no damage to articulating surfaces when assessed after three weeks” and the “EDLA particles were trapped in synovial membrane, with minimal foreign body reactions as a consequence” (col.33 ll.41-45). There was ''no evidence of inflammation, tenderness or altered range of motion on weekly physical examination of knees, in any animal” (col.32 ll.41-43). Also, observations for swelling, warmth, and discoloration all resulted in the negative (col.32 ll.62-63).
Response to Arguments
Applicant's arguments filed May 5, 2026 have been fully considered but they are not persuasive. Applicant argues that the rejection “is improper at least because when the ‘591 patent is excluded as prior art, the instant claims are not merely an obvious variation of Claims 33-49 of the ’591 patent”. (Remarks, 12-13, May 5, 2026.)
First, Applicant appears to be confusing an obviousness rejection under 35 U.S.C. 103(a) with obviousness-type double patenting. In the former the claims under examination are considered over prior art. In the latter the claims under examination are reviewed over the reference patent’s claims: there is no question of ‘prior’ art or exclusion thereof.
Second, Abbvie Inc. v. Mathilda & Terrence Kennedy Inst. Of Rheumatology Trust appears distinguishable because here the obviousness-type double patenting is made over Trieu. In other words the rejection does not rely on a disclosure in the reference patent alone but that in combination with a secondary reference.
Lastly as noted Applicant argues “surprising results and satisfaction of a long-felt unmet need achieved” relying on the Meyers and the Wilhelm Affidavits. (Remarks, 11-12, May 5, 2026.) These Affidavits concern the Kush® product, which is covered by US Patent no. 8153591 (Masters, Particles for Osteoarthritis Treatment: Injected Wet Particulate of Collagen-Elastin-Glycosaminoglycan Matrix into Synovial Fluid, Mechanically cushion Joint with Long duration, NPL cite 2, 05/31/2019 IDS). This patent (US 8153591) is the subject of the obviousness-type double patenting, for which Applicant has not submitted a terminal disclaimer or has otherwise overcome.
Regarding the double patenting rejection over U.S. Patent 11,890,371, Applicant states it “is concurrently filing a Terminal Disclaimer in compliance with 37 C.F.R. § 1.321, disclaiming any term…”. (Remarks, 13 last para., May 5, 2026.)
No such disclaimer appears on the record.
CONCLUSION
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 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 H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614
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