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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6, 2026 has been entered.
In that response, claims 1, 14, 17, 19, and 20 were amended. Claims 1-24 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 Objections
Claim 3 is objected to because of the following informalities: “collage”. Appropriate correction is required.
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.
Claims 1-24 are 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. The disclosure does not reasonably convey that Applicant had possession of the biocompatible granules of claims 1 and 14, “wherein the plurality of biocompatible granules is configured to withstand a mean compressive force of at least 1 Newton (N)”.
The methodology for determining adequacy of written description entails (1) for each claim, determining what the claim as a whole covers, (2) reviewing the entire application to understand how applicant provides support for the claimed invention including each element and/or step, and (3) determining whether there is sufficient written description to inform a skilled artisan that applicant was in possession of the claimed invention as a whole at the time the application was filed. MPEP §2163(II). Also the “written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice …, reduction to drawings …, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.” MPEP §2163(II)(A)(3)(a)(ii) (citations omitted). The “Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 ‘merely by clearly describing one embodiment of the thing claimed’.” Id. (citations omitted).
(1) Claim 1 as a whole covers an implant composition comprising (i) a plurality of biocompatible granules, made of any biocompatible material, wherein each granule has irregularly distributed surface indentations, at least one of which indentations is a dimple, and the plurality of the granules “is configured to withstand a mean compressive force of at least 1 Newton (N)”, and (ii) a collagen coating over at least some of the granules. The phrase “wherein the plurality of biocompatible granules is configured to withstand a mean compressive force of at least 1 Newton (N)” refers to part (i) in the implant composition of claim 1, not the implant composition at large of claim 1. Note that “at least 1 Newton” has no upper limit.
Claim 14 is drawn to a method of forming the implant, comprising forming the plurality of biocompatible granules of claim 1, part (i), wherein the plurality of biocompatible granules is configured to withstand a mean compressive force of at least 1 Newton (N).
(2) The entire application has been reviewed to understand how applicant provides support for the claimed invention. The Specification refers to “compressive force”, and “force of failure” in three instances. The two terms could mean different parameters.
“In one embodiment of the invention the granules can withstand a mean compressive force of at least 1 N to ensure that the granules do not break during insertion.” Paragraph [0018].
“According to FIG. 8, results show the significant higher mechanical force of failure of granules made according to the present invention as compared to highly porous competitor products (Bio-Oss®, …, BoneCeramic™ (Straumann, Switzerland)) with no reduction as compared to the spherical granules without indentations. “ Para.[0047]
“Granules having a spherical shape with the internal porosity concentrated in the core of the granule showed an average force of failure at 1.5 N. The method described in this invention achieved an increase in the intergranular porosity from 40% to 51 % while not reducing the force at failure.” Paragraph [0074]
None of the above passages, nor the rest of the disclosure, discusses the actual embodiment whose force of failure is being referred to, i.e., the granule material, surface indentation distribution, shape, or size, or overall granule porosity. Consequently it is unknown whether these passages actually relate to the now-claimed subject matter, a plurality of biocompatible granules wherein each granule has irregularly distributed surface indentations, at least one of which indentations is a dimple, and the plurality of the granules “is configured to withstand a mean compressive force of at least 1 Newton (N)”.
Regarding the third bullet point it is noted that “[g]ranules having a spherical shape with the internal porosity concentrated in the core of the granule” is not a limitation in the current claims.
The third bullet point also is the sole discussion in the disclosure of any embodiment of a plurality of biocompatible granules having more than 1 N force of failure, i.e., 1.5 N for unidentified embodiment. There is no “relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show” the unlimited mean compressive force of “at least 1 Newton”.
Figure 8 shows “Force (N)” for five bone graft particles. The two left samples tested are shown to have a “mechanical force of failure” above 1 N: “Calcium phosphate granules with indentations acc. to the invention 450 – 1000 µm” (hereinafter Sample 1) and “spherical calcium phosphate granules 450 – 1000 µm” (hereinafter Sample 2).
Presumably Sample 1 could represent the subject matter now claimed; however this is unknown because the disclosure does not state how the particular embodiment tested and shown in Figure 8 was prepared or what it was, i.e., the size of the indentations, porosity, whether any component additional to calcium phosphate was present, etc. Similarly for Sample 2 there is no information additional to the sample label given, and it is unclear how this differs from Sample 1, and also whether Sample 2 granules had any indentations, whether according to the invention or otherwise.
It is further noted that Figures 2a-c, 3a-b, 4a-d, and 5a-d show granule embodiments comprising wide ranges of sizes and indentation shapes and distributions, and therefore Samples 1 and 2 cannot be reasonably attributed to any one of the embodiments in those figures. Therefore it is questionable whether the Specification actually discloses even a single specific embodiment meeting the limitation phrase.
The specification is devoid of any disclosure regarding how the biocompatible granules is to be “configured to withstand a mean compressive force of at least 1 Newton (N)”. As discussed above, Samples 1 and 2 in Figure 8 which did have force of failure above 1N is disclosed without their specific constitution. There is no description of a representative number of species by actual reduction to practice. None of the present claims recite an actual material for the biocompatible granules, meaning the claims encompass any “biocompatible” material. The universe of such material known and yet to be discovered is vastly diverse.
Furthermore there is no disclosure of “relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus” of any and all granules configured to withstand a mean compressive force of at least 1 Newton. MPEP §2163(II)(A)(3)(a)(ii) (citations omitted). This is an instance where the “specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 ‘merely by clearly describing one embodiment of the thing claimed’.” Id. (citations omitted).
(3) Therefore it is determined that there is not sufficient written description to inform a skilled artisan that applicant was in possession of the claimed invention as a whole at the time the application was filed.
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 1-24 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (WO 02/060504 A1) in view of Maspero (US 2005/0209704) and Kuttappan (Kuttappan, S., et al., Biomimetic composite scaffolds containing bioceramics and collagen/gelatin for bone tissue engineering - A mini review, International Journal of Biological Macromolecules 93, Part B, December 2016, 1390-1401).
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, 8 and accompanying text). “The bodies of the individually produced particles may be of irregular shape…” with a plurality of cavities (p.2 lines 12-13, p.10 lines 25-34; see also p.4 lines 6-10,; claims 4, 19; see Fig.6 and accompanying text). 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). The surface indentations are 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.
Regarding “wherein the plurality of biocompatible granules is configured to withstand a mean compressive force of at least 1 Newton (N)” now in claims 1 and 14, Thomas teaches as follows (p.1 lines 10-17).
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Applicant discloses, “the granules can withstand a mean compressive force of at least 1 N to ensure that the granules do not break during insertion.” (Specification Paragraph [0018]). Since Thomas expressly teaches packing the bone filler material into defects or gaps in vivo the material would withstand typical forces involved during such packing and comprise a mean compressive force of at least 1 N.
Regarding claims 21-23, Thomas teaches the radii of the dimples as 200-400 microns or greater (p.3 lines 11-16), meaning the porogen diameter would be 400 microns or greater, e.g., 400 microns. Claims 22 and 23 are product claims, and recite a product-by-process of contacting spheres of 100 to 1000 microns. In other words the dimension of the indentation actually resulting from the contacting step is not recited.
Regarding claim 24, Thomas teaches, “a plurality of cavities may be provided within the body” of the particle, “[t]he bone filler material may even comprise a mixture of such spherically and irregularly shaped individually produced particles” (p.4 lines 4-8; see p.3 line27-p.4 line 4), providing as many dimples as possible (p.3 lines 16-18), and providing “a greater or lesser number of dimples (not shown)” (p.8 lines 31-32). Furthermore a plurality of particles 80 are sintered together to form an irregularly shaped individually produced article (p.10 lines 20-34), with the granule comprising multiple indentations. Therefore the skilled person would understand the percent of the surface occupied by the indentations can be varied as needed. Optimization within prior art conditions or through routine experimentation does not support patentability absent comparative evidence of criticality of the claimed range. See MPEP § 2144.05 (II) (citations omitted).
Thomas teaches “packing” the particulate bone filler material, thus the material would be molded into an implant.
Thomas does not specifically teach a collagen coating disposed about at least some of the granules as recited in claims 1 and 14.
Maspero teaches (title; abstract; paras. 0011-38; Figs.1-4; claims 14-62) an “implant for a cavity in a bone of a living organism” comprising “granules which are selected from the group including biopolymers, bioglasses, bioceramics preferably calcium sulfate,… provided with a coating, which comprises at least one layer of a biocompatible and biodegradable polymer…” (abstract). The implant comprises “macro porosity, which allows tissue in-growth” (para.0011; see para.0014). Maspero teaches solid granules as well as porous granules (paras.0016, 0024, 0039; claims 23, 33, 44, 54).
The coating is between 2 µm to 300 µm thick, e.g., about 5 µm, which is within the ranges in claims 10-12 (para.0021). The coating may be performed via immersion or spray-coating with a solvent for easy control of the thickness and for forming multiple coating layers (paras.0029, 0049) and include active agents (para.0029). The granules are moldable (para.0055).
Kuttappan reviews composite scaffolds made of gelatin/collagen in combination with bioactive ceramics for bone tissue engineering (title; abstract). Kuttappan discusses natural bone composition, comprising collagen and inorganic apatite (p.1390-91 section 2, Fig. 1 and accompanying text), the different sources of collagen for biomedical applications, and collagen-bioactive ceramic composites such as “polymer coating on bioceramics” (p.1398 section 6; see pp.1391-98).
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, Maspero, and Kuttappan and devise a coating comprising collagen over Thomas’s dimpled particles as recited in the instant claims. The skilled person would have been motivated to do so because (i) all references are drawn to material for treating bones, (ii) Thomas teaches that its particles can be mixed with other components such as blood-derived products that act as a binder, (iii) Maspero teaches implant for a cavity in a bone of a living organism comprising granules with a coating of a biocompatible and biodegradable polymer, and (iv) collagen is a naturally occurring matrix polymer which as Kuttappan discusses is a natural bone component, and widely used in bone tissue engineering applications, e.g., as polymer coating on bioceramics, for “efficacious bone repair” in many scenarios (p.1398 section 6).
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, as well as Maspero and Kuttappan, does not teach the configuration to withstand a mean compressive force of at least 1 Newton (N). (Remarks, 7-8, March 6, 2026.)
However as noted above Applicant discloses, “the granules can withstand a mean compressive force of at least 1 N to ensure that the granules do not break during insertion.” (Specification Paragraph [0018]). Thomas expressly teaches packing the bone filler material into defects or gaps in vivo, meaning the material would withstand typical forces involved during such packing and comprise a mean compressive force of at least 1 N.
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 1-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-5, 7, 10, 11, 21-19, and 31-33 of copending Application No. 16/471107 (reference application) in view of Kuttappan (Kuttappan, S., et al., Biomimetic composite scaffolds containing bioceramics and collagen/gelatin for bone tissue engineering - A mini review, International Journal of Biological Macromolecules 93, Part B, December 2016, 1390-1401).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to implant compositions comprising: a plurality of biocompatible granules, at least a portion of the granules having surface indentations; and a coating disposed about at least some of the granules. The differences are that the present claims recite a collagen coating, but Kuttappan reviews composite scaffolds made of gelatin/collagen in combination with bioactive ceramics for bone tissue engineering (title; abstract). Kuttappan discusses natural bone composition, comprising collagen and inorganic apatite (p.1390-91 section 2, Fig. 1 and accompanying text), and collagen-bioactive ceramic composites such as “polymer coating on bioceramics”, for “efficacious bone repair” in many scenarios (p.1398 section 6; see pp.1391-98). Therefore the person of ordinary skill would have been motivated to include collagen in the coating.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 and 23-26 of copending Application No. 17/234365 (reference application) in view of Kuttappan (Kuttappan, S., et al., Biomimetic composite scaffolds containing bioceramics and collagen/gelatin for bone tissue engineering - A mini review, International Journal of Biological Macromolecules 93, Part B, December 2016, 1390-1401).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to implant compositions comprising: a plurality of biocompatible granules, at least a portion of the granules having surface indentations; and a coating disposed about at least some of the granules. The differences are that the present claims recite a collagen coating, but Kuttappan reviews composite scaffolds made of gelatin/collagen in combination with bioactive ceramics for bone tissue engineering (title; abstract). Kuttappan discusses natural bone composition, comprising collagen and inorganic apatite (p.1390-91 section 2, Fig. 1 and accompanying text), and collagen-bioactive ceramic composites such as “polymer coating on bioceramics”, for “efficacious bone repair” in many scenarios (p.1398 section 6; see pp.1391-98). Therefore the person of ordinary skill would have been motivated to include collagen in the coating. The ’365 application’s claims further recite additional limitations and therefore are narrower.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 14-18 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 13-18, 21, and 22 of copending Application No. 17/332833 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to method of preparing implant compositions comprising: providing a plurality of biocompatible granules, at least a portion of the granules having surface indentations; and coating at least some of the granules. The differences are that the present claims recite a collagen coating. However Kuttappan reviews composite scaffolds made of gelatin/collagen in combination with bioactive ceramics for bone tissue engineering (title; abstract). Kuttappan discusses natural bone composition, comprising collagen and inorganic apatite (p.1390-91 section 2, Fig. 1 and accompanying text), and collagen-bioactive ceramic composites such as “polymer coating on bioceramics”, for “efficacious bone repair” in many scenarios (p.1398 section 6; see pp.1391-98). Therefore the person of ordinary skill would have been motivated to include collagen in the coating. The ’833 application’s claims recite further limitation and thus are narrower in scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of U.S. Patent No. 7731756 in view of Kuttappan (Kuttappan, S., et al., Biomimetic composite scaffolds containing bioceramics and collagen/gelatin for bone tissue engineering - A mini review, International Journal of Biological Macromolecules 93, Part B, December 2016, 1390-1401).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to implant compositions comprising: a plurality of biocompatible granules, at least a portion of the granules having surface indentations; and a coating disposed about at least some of the granules. The differences are that the present claims recite a collagen coating, but Kuttappan reviews composite scaffolds made of gelatin/collagen in combination with bioactive ceramics for bone tissue engineering (title; abstract). Kuttappan discusses natural bone composition, comprising collagen and inorganic apatite (p.1390-91 section 2, Fig. 1 and accompanying text), and collagen-bioactive ceramic composites such as “polymer coating on bioceramics”, for “efficacious bone repair” in many scenarios (p.1398 section 6; see pp.1391-98). Therefore the person of ordinary skill would have been motivated to include collagen in the coating.
Claims 1-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of U.S. Patent No. 8163030 in view of Kuttappan (Kuttappan, S., et al., Biomimetic composite scaffolds containing bioceramics and collagen/gelatin for bone tissue engineering - A mini review, International Journal of Biological Macromolecules 93, Part B, December 2016, 1390-1401).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to implant compositions comprising: a plurality of biocompatible granules, at least a portion of the granules having surface indentations; and a coating disposed about at least some of the granules. The differences are that the present claims recite a collagen coating, but Kuttappan reviews composite scaffolds made of gelatin/collagen in combination with bioactive ceramics for bone tissue engineering (title; abstract). Kuttappan discusses natural bone composition, comprising collagen and inorganic apatite (p.1390-91 section 2, Fig. 1 and accompanying text), and collagen-bioactive ceramic composites such as “polymer coating on bioceramics”, for “efficacious bone repair” in many scenarios (p.1398 section 6; see pp.1391-98). Therefore the person of ordinary skill would have been motivated to include collagen in the coating.
Claims 1-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 8153148 in view of Kuttappan (Kuttappan, S., et al., Biomimetic composite scaffolds containing bioceramics and collagen/gelatin for bone tissue engineering - A mini review, International Journal of Biological Macromolecules 93, Part B, December 2016, 1390-1401).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to implant compositions comprising: a plurality of polymer-coated biocompatible and biodegradable granules. The differences are that the present claims recite a collagen coating, but Kuttappan reviews composite scaffolds made of gelatin/collagen in combination with bioactive ceramics for bone tissue engineering (title; abstract). Kuttappan discusses natural bone composition, comprising collagen and inorganic apatite (p.1390-91 section 2, Fig. 1 and accompanying text), and collagen-bioactive ceramic composites such as “polymer coating on bioceramics”, for “efficacious bone repair” in many scenarios (p.1398 section 6; see pp.1391-98). Therefore the person of ordinary skill would have been motivated to include collagen in the coating.
Response to Arguments
Applicant's arguments filed March 6, 2026 have been fully considered but they are not persuasive. Applicant contends the Office did not explain why the skilled person beginning from the claimed subject matter of the reference claims would have “apprehended a lack of efficacious bone repair such chat they would have attempted to look to any reference whatsoever… to seek to modify the claimed subject matter”. (Remarks, 10, March 6, 2026.)
In response it is noted that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Thus the Office need not look for indications of the skilled person’s apprehending a lack of efficacious bone repair as problem. Here the skilled person would have been motivated to do modify the bone implant material of the reference patent or application’s claims with Kuttappan as it teaches collagen-bioactive ceramic composites such as “polymer coating on bioceramics”, for “efficacious bone repair” in many scenarios (p.1398 section 6; see pp.1391-98).
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
