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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 23, 2026 has been entered.
In that response, claims 1 and 11 were amended, claims 25 and 26 were cancelled, and claims 27 and 28 were added. Claims 1-14, 23, 24, and 27-28 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 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 1-14, 23, 24, and 27-28 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.
Claims 1 and 11 recites “non-hollow and defining a plurality of irregularly distributed surface indentations”. In the claim phrase at issue, the boundary between “non-hollow” and “defining a plurality of irregularly distributed surface indentations” is unclear. Stated another way, the term “non-hollow” in claim s is a relative term which renders the claim indefinite. The and term “non-hollow” 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.
Looking to the disclosure, “non-hollow” (as well as “hollow”) is not used in the written description. Generally “hollow” means having an empty space inside rather than being completely solid; therefore “non-hollow” would mean not having an empty space inside. However “surface indentations,” depending on the size the indentation, would make a particle “hollow”. The disclosure states “indentations of increasing size relative to the size of the granules; the granules being prepared using porogens within varying size ranges…” (Specification para.[0032]); and “FIGS. 4a to 4d show samples made using cylindrical granules having indentations of increasing size relative to the size of the granules, wherein the granules are prepared using porogens within varying size ranges and at a constant pressure” (Specification para.[0034]). Figure 4a is not hollow; however as the porogen used gets larger in Figures 4c and 4d, larger surface indentations appear and whether those particles could be considered “hollow” or “non-hollow” depends on what those terms mean.
None of the dependent claims resolves this issue and therefore they are also rejected on this ground.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1-14, 23, 24, and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (WO 02/060504 A1) in view of Ruffieux (US 2005/0251266).
Thomas teaches “bone filler material [which] includes a plurality of particles of bioactive material”, including resorbable material such as calcium phosphate (title; abstract; see p.1 lines 1-17, p.2 lines 12-14, p.3 lines 2-7, p.4 lines 6-10, p.7 lines 3-8; claims 1-20, Figs. 1-4, 6 and accompanying text). While Figure 6 shows a sphere with a hollow, Thomas’s particles are not limited thereto. Specifically Thoms teaches, “[t]he bodies of the individually produced particles may be of irregular shape…” with a plurality of cavities (p.2 lines 12-13 (emphasis added), p.10 lines 25-34; see claims 4, 19).
In another version, the body may be of irregular shape, and a plurality of cavities may be provided within the body. The bone filler material may even comprise a mixture of such spherically and irregularly shaped individually produced particles.(P.4 lines 6-10 (emphases added).)
Each particle has at least one cavity, “in the form of a surface indentation or concavity” that is hemispherical or described as “dimples” (p.3 lines 8-15). As noted above Applicant here has not disclosed “non-hollow” as a feature of the particles, and appears to carve it out from the disclosed subject matter to overcome Thomas. However Thomas teaches cavity and indentation as alternatives: “the or each cavity in each individually produced particle may be in the form of a surface indentation or concavity” (p.3 lines 11-14; claim 13). Thomas does not limit the fugitive phase or the porogen to a specific material but it “can, for example, be stearic acid balls” (p.10 lines 6-7). Substituting equivalents known for the same purpose, where the equivalency has been recognized in the prior art, presents strong evidence of obviousness; an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. MPEP §2144.06 (II) (citations omitted).
The surface indentations can be made by hemispherical protrusions on a die that is pressed into a ‘base material’ (e.g., calcium phosphate), and compacted to form the particle, and then sintered (p.5 line 21– p.6 line 24). In other words the hemispherical protrusion is a “spherical porogen” that is pressed into the base material granules prior to compaction and sintering, i.e. when the base material is unhardened. Thomas states as follows (p.10 lines 20-30).
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The shells of adjacent particles sinter together to produce an “irregularly shaped individually produced particle, having a plurality of the cavities 84”. The “irregularly shaped” indicates random, i.e., irregular distribution of indentations. Furthermore the sintering together of shells would result in some degree of laterally overlapping indentations as recited in claim 28.
Thomas teaches “packing” the particulate bone filler material, thus the material would also be “moldable” (p.7 lines 4-11).
Thomas does not specifically teach a biocompatible polymer or polypeptide disposed about at least some of the granules as recited in claims 1 and 11 and the size of the macropores or the space between particles recited in claim 27.
Ruffieux is drawn to “moldable bone implants for use in a bone defect or wound include a plurality of biocompatible granules and a biocompatible polymer that together form an implant mass” (abstract; claims 1, 5-7, 9, 10, 17-19; see entire document). Biocompatible polymer coating material specifically includes polypeptides and poly(amino acid) (para. 0059; claim 7; see para.0046). The coating may comprise one or more layers of varying average thickness and purposes (paras. 0067, 0070). Like Thomas, Ruffieux teaches using calcium phosphate ceramic granules for its abilities such as direct adhesion with existing bone tissue and providing a scaffold for the formation of new bone (paras.0017, 0045, 0053; claims 3, 4). In some embodiments the “granules include a macroscopic opening in the granular wall of a hollow granule” or indentations which “promote[ ] tissue in-growth into the matrix of the bone implant” (para.0051; see para. 0055). The macropores preferably have an average diameter of about 100 µm to about 500 µm (para.0083). Ruffieux teaches organic plasticizers and active agents over the granules (paras.0060, 0066, 0085; claims 1, 9).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of Thomas and Ruffieux and provide a coating over Thomas’s particles as recited in the instant claims. The skilled person would have been motivated to do so because both are drawn to particulate bone filler materials comprising calcium phosphates, Thomas teaches that its particles can be mixed with other components such as blood-derived products that act as a binder, and Ruffieux teaches that a moldable implant composition made with the particulate bone filler and a polymer disposed about the bone filler can be “formed into a desired shape, the implant composition is easily, and if desired, quickly hardened to form a rigid implant” (para.0012).
Response to Arguments
Although the rejections have been modified to address the claim amendments Applicant’s arguments are addressed now to the extent not rendered moot and are relevant to the above rejections. Applicant argues that Thomas in view of Ruffieux does not suggest “a plurality of biocompatible granules…being non-hollow and defining a plurality of irregularly distributed surface indentations”. (Remarks, 5-6, March 23, 2026.) “Thomas describes sintering specifically with reference to particles 80, which have concavities 84 in hollow shells 82 which are not “non-hollow”. (Remarks, 6 second-third paras., March 23, 2026.) Furthermore these particles do not define “a plurality of surface indentations” because particle 80 is a spherical, hollow shell with a cavity 84 which would require an “unreasonably broad interpretation of an indentation” to consider as an indentation. (Remarks, 6 fourth para.)
In response it is noted that Applicant’s arguments relies on Thomas’s Figure 6 alone. However as noted above while Figure 6 shows a sphere with a hollow, Thomas’s particles are not limited thereto. Specifically Thoms teaches, “[t]he bodies of the individually produced particles may be of irregular shape…” with a plurality of cavities (p.2 lines 12-13 (emphasis added); see claims 4, 12, 19).
In another version, the body may be of irregular shape, and a plurality of cavities may be provided within the body. The bone filler material may even comprise a mixture of such spherically and irregularly shaped individually produced particles.(P.4 lines 6-10 (emphases added).)
In this fashion, an irregularly shaped individually produced particle, having a plurality of the cavities 84, is obtained. Such an irregularly shaped individually produced article can thus also be considered to be a cluster or pocket of a plurality of the particles 10, tightly bound together. The bone filler material of the invention can then comprise a mixture of the spherical particles 80 and the irregularly shaped particles, with the spherical particles 80 being smaller than the irregularly shaped particles. (P.10 lines 25-34.)
Regarding the issue of Thomas’s “cavity” versus the claims’ “indentation”, it is noted that the boundary between “non-hollow” and “defining a plurality of irregularly distributed surface indentations” is blurry at best. Applicant here has not disclosed “non-hollow” as a feature of the particles, and appears to carve it out from the disclosed subject matter to overcome Thomas. However claims 1 and 11 also recite “defining a plurality of irregularly distributed surface indentations” which is not limited in cavity size and/or particle size. Furthermore Thomas teaches cavity and indentation as alternatives: “the or each cavity in each individually produced particle may be in the form of a surface indentation or concavity” (p.3 lines 11-14; claim 13).
Applicant next contends that even if the skilled person “would have had a rational reason to only sinter particles of FIGS. 1 and 2 instead of FIG. 6 of Thomas…would not have arrived at a plurality of granules each defining a plurality of irregularly distributed surface indentations, … formed by pressing spherical porogen into an initial surface of precursor granules while…unhardened”. (Remarks, 6 second last para.) Furthermore Thomas’s irregularly shaped particles are made of the particles 80, and sintering is described specifically for particles 80 which have concavities 84 and hollow shells 82, which are not “non-hollow”, and do not define a plurality of surface indentations.
It is not clear why Applicant is focusing on sintering of the particles of Figures 1 and 2 in Thomas. The rejections have not relied on such an interpretation. Furthermore it is noted first that as noted above what is “non-hollow” but “defines a plurality of …surface indentations” is unclear. Also Thomas teaches cavity and indentation as alternatives: “the or each cavity in each individually produced particle may be in the form of a surface indentation or concavity”. Second Thomas teaches the shells of adjacent particles sintered together which produces an “irregularly shaped individually produced particle, having a plurality of the cavities 84”.
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 1-14, 23, 24, and 27-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of U.S. Patent No. 7731756 in view of Thomas (WO 2002/060504A1).
Although the claims at issue are not identical, they are not patentably distinct from each other. Both claim sets are drawn to biocompatible implant for the treatment of defects in a living organism, comprising an open porous scaffold and a membrane covering at least a part of said scaffold, wherein said scaffold is comprised of fused, biocompatible, biodegradable granules selected from the group including porous granules and hollow granules with at least one opening in the granule, and a mixture thereof, a major portion of said granules being coated with at least one biocompatible and biodegradable layer of a polymer selected from a group that includes poly(amino acids) and polypeptides. The ‘756 patent’s claims recite further limitations, and therefore are narrower than the present claims. The ‘756 patent claims do not recite forming the surface indentations by pressing spherical porogen into the surface of the granules while they are unhardened. However Thomas teaches forming surface indentations on particles using hemispherical protrusions on a die that is pressed into a ‘base material’ (e.g., calcium phosphate), and compacted to form the particle, and then sintered (p.5 line 21– p.6 line 24). In other words the hemispherical protrusion is a “spherical porogen” that is pressed into the base material granules prior to compaction and sintering, i.e. unhardened. The skilled person would have been motivated to do modify the bone implant material of the ’756 patent’s claims with Thomas’s inter-particles pores because it is also drawn to porous bone filler material, and teaches its particles can be mixed with other components such as blood-derived products that act as a binder, and packed into bone defects.
Claims 1-14 and 23-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13, 17-23, 31-35, 37, and 38 of U.S. Patent No. 8163030 in view of in view of Thomas (WO 2002/060504A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to implant mass composition comprising: a plurality of biocompatible synthetic non-polymeric granules; a biocompatible polymer coating at least a portion of the implant mass, the implant mass comprising a composite matrix of the granules bound to each other by adhesion between the biocompatible polymer disposed on adjacent granules, and macropores between adjacent granules, so as to form an implant mass comprising a plurality of distinct granules coated with said biocompatible polymer. The ’030 patent claims further recite “said biocompatible polymer comprising about 4% to about 20% of the total weight of the implant mass” and therefore anticipate the present claims.
The ’030 patent claims do not recite forming the surface indentations by pressing spherical porogen into the surface of the granules while they are unhardened. Thomas teaches forming surface indentations on particles using hemispherical protrusions on a die that is pressed into a ‘base material’ (e.g., calcium phosphate), and compacted to form the particle, and then sintered (p.5 line 21-p.6 line 24). In other words the hemispherical protrusion is a “spherical porogen” that is pressed into the base material granules prior to compaction and sintering, i.e. unhardened. Thomas further teaches irregularly shaped particles and sintering of several adjacent particles with pores therein which would produce irregularly shaped particles. The skilled person would have been motivated to do combine Thomas’s teaching because it is also drawn to bone filler material, and teaches its particles can be mixed with other components such as blood-derived products that act as a binder, and packed into bone defects.
Claims 1-14, 23, 24, and 27-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 7-31 of U.S. Patent No. 8153148 in view of Thomas (WO 2002/060504A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to biocompatible and biodegradable implant comprising polymer-coated biocompatible and biodegradable granules, said granules being made of biocompatible and biodegradable materials; a major portion of the surface area of said granules being coated with at least one biocompatible and biodegradable layer of a polymer. The ’148 patent claims do not recite forming the surface indentations by pressing spherical porogen into the surface of the granules while they are unhardened. Thomas teaches forming surface indentations on particles using hemispherical protrusions on a die that is pressed into a ‘base material’ (e.g., calcium phosphate), and compacted to form the particle, and then sintered (p.5 line 21-p.6 line 24). In other words the hemispherical protrusion is a “spherical porogen” that is pressed into the base material granules prior to compaction and sintering, i.e. unhardened. Thomas further teaches irregularly shaped particles and sintering of several adjacent particles with pores therein which would produce irregularly shaped particles. The skilled person would have been motivated to do combine Thomas’s teaching because it is also drawn to bone filler material, and teaches its particles can be mixed with other components such as blood-derived products that act as a binder, and packed into bone defects.
Claims 1-14, 23, 24, and 27-28 over claims 1-13 and 22-24 of copending Application No. 17/472897 (see 10/21/2025 Office action p.11).
Applicant filed a terminal disclaimer over Application No. 17/472897 on March 23, 2026, which was approved on even date. Applicant petitioned to withdraw an inadvertently filed terminal disclaimer in this case over Application No. 17/332,833. The Decision on Petition of Aug. 21, 2026 granting that petition incorrectly identified Application No. 17/472897. Should the discrepancy remain in the file wrapper the double-patenting rejection over claims of the ‘897 application may be re-instated.
Response to Arguments
Applicant's arguments filed March 23, 2026 have been fully considered but they are not persuasive. Applicant argues the Office did not explain why the skilled person, beginning from the claimed subject matter of the applied references, would have apprehended a need for improvement and seek to modify the claimed subject matter. (Remarks, 8, March 23, 2026.)
In response it is noted that each of the above double-patenting rejection explains why a skilled person would have been motivated to modify the claimed subject matter, i.e., because Thomas teaches a further advantage of the claimed subject matter. “The expectation of some advantage is the strongest rationale for combining references”. MPEP § 2144(II). “Because the desire to enhance commercial opportunities by improving a product or process is universal—and even common-sensical—we have held that there exists in these situations a motivation to combine prior art references even absent any hint of suggestion in the references themselves.” MPEP § 2144(II) (citations omitted).
CONCLUSION
No claim is allowed.
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
