Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined pursuant to the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of the Claims
The Examiner acknowledges receipt of Applicants’ Response, filed 27 April 2026. Claims 1 and 2 are amended therein. Claims 16 - 22 remain withdrawn as being directed to a non-elected invention. Accordingly, claims 1 – 15 remain available for active consideration.
REJECTIONS WITHDRAWN
Rejections Pursuant to 35 U.S.C. § 112
The rejections pursuant to 35 U.S.C. § 112(b) set forth in the Action of 12 February 2026 are hereby withdrawn in light of Applicants’ amendment of the claims.
Rejections Pursuant to 35 U.S.C. § 103
The rejection pursuant to 35 U.S.C. § 103 set forth in the Action of 12 February 2026 is hereby withdrawn in light of Applicants’ amendment of the claims.
NEW GROUNDS OF REJECTION
Rejections Pursuant to 35 U.S.C. § 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.
Claim 1, and claims 2 – 15, dependent therefrom, are rejected pursuant to 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 1 recites a limitation directed to “MgO, monobasic potassium phosphate, monobasic sodium phosphate, proteoglycans, calcium sodium phosphosilicate present in an amount between 1-15 weight percent of the dry composition (emphasis added).” It is unclear grammatically whether the quantitative loading recitation applies to calcium sodium phosphosilicate only, or to all five components preceding the limitation. The Examiner notes that Applicants’ specification discloses that “Calcium sodium phosphosilicate is preferably added at about 1-15 weight percent (see ¶[0028]).” On the basis of this disclosure, and in the interests of compact prosecution, the Examiner is interpreting the limitation as applying to calcium sodium phosphosilicate only.
Rejections Pursuant to 35 U.S.C. § 103
The following is a quotation of 35 U.S.C. § 103 that forms the basis for all obviousness rejections set forth in this Office Action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the Examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention absent any evidence to the contrary. Applicants are advised of the obligation pursuant to 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 – 15 are rejected pursuant to 35 U.S.C. § 103, as being obvious over US 2018/0326124 A1 to Diaz, D., et al., published 15 November 2018, cited on the Information Disclosure Statement (IDS) filed 29 November 2022, cite no. 1 (USPATAPP) (“Diaz ‘124”), in view of US 5,231,169 to Constanz, B. and S. Gunasekaran, issued 27 July 1993 (“Constanz ‘169”), US 5,129,905 to Constanz, B., issued 14 July 1992 (“Constanz ‘905”), and US 2017/0354501 A1 to Jie, Q., et al., published 14 December 2017 ("Jie '501").
The Examiner directs Applicants’ attention to the fact that the instant rejection applies the same references as applied in previous rejections of the claims pursuant to 35 U.S.C. § 103. However, the teachings of these references are applied in a manner different from how those teachings were applied in a prior rejection, necessitated by Applicants’ amendment of the claims, thus constituting a new basis of rejection.
The Invention As Claimed
Applicants claim a bio-material composition, comprising a dry potassium phosphate-based mixture comprising MgO, monobasic potassium phosphate, monobasic sodium phosphate, proteoglycans, silica bioactive glass present in an amount between 1 – 15% wgt of the dry composition, and tobramycin, wherein the weight percent ratio of monobasic potassium phosphate to MgO is between about 3: 1 and 1: 1, wherein the mixture is mixed with an aqueous solution to form a reabsorbable bio-material slurry, wherein the proteoglycans are between about 1 – 10% wgt of the dry composition, wherein the proteoglycans are provided in a carrier matrix selected from a mineral-collagen composite matrix, fibers, granules, morcellized fibers, nanoparticles, or combinations thereof, wherein the proteoglycans are between about 1 – 5%, or about 1.5 – 2.5% wgt, or about 1.5 – 3% wgt, or about 1.5 – 3.5% wgt, or about 1.5 – 4% wgt, or about 1.5 – 4.5% wgt, or about 2% wgt, or about 1.5 – 2% wgt, or about 1.5 – 2.5% wgt, of the dry composition, and wherein the tobramycin is between about 1 – 5% wgt of the dry composition.
The Teachings of the Cited Art
Diaz ‘124 discloses a dry potassium phosphate-based mixture comprising (a) MgO, monobasic potassium phosphate, monobasic sodium phosphate, a reabsorbing agent, and a tertiary calcium phosphate, wherein the weight percent ratio of the monobasic potassium phosphate to the magnesium oxide is between about 3:1 and 1:1; and (b) an aqueous solution (see Abstract), wherein the mixture further comprises bioactive glass compositions (see ¶[0070]), and an antibiotic present between about 1 and 5% wgt (see ¶[0031]), wherein the antibiotic is tobramycin (see ¶[0076]). The reference does not disclose compositions comprising proteoglycans in a mineralized-collagen complex, with the proteoglycans present at about 1 – 10% wgt, or bioactive glass compositions comprising a silica bioactive glass at 1 – 15% wgt. The disclosures of Constanz ‘169, Constanz ‘905, and Jie ‘501 remedy those deficiencies.
Constanz ‘169 discloses the preparation of mineralized collagen with desirable physical characteristics mimicking the characteristics of bone (see Abstract), wherein the mineralized collagen is prepared by a process comprising the simultaneous gradual, preferably continuous, addition of a source of soluble calcium and a source of soluble phosphate to a collagen-fibril-containing medium (see Col. 2, ll. 19 – 23), wherein the resulting product, after thorough washing in distilled water, has calcium phosphate stably distributed with the fibrils to form a substantially uniform composition of calcium phosphate and collagen, with the mineral phase displaying a Ca:P ratio of 1.2 - 1.8, hexagonal symmetry, and membership in the hydroxyapatite mineral group (see Col. 2, ll. 25 – 31), wherein the collagen may come from bone, tendons, skin, or the like, preferably collagen comprising a combination of two strands of collagen α2 chains (see Col. 2, ll. 34 – 37), wherein the phosphate and calcium are gradually added as solutions, at concentrations in the range of about 0.001 - 0.5 M, or about 0.025 - 0.2 M (see Col. 2, ll. 58 – 60), wherein, by varying the calcium to phosphate ratio, a range of mineral compositions may be attained (see Col. 3, ll. 51 – 53), and wherein the resulting composition may be used for the production of prosthetic devices, bone filler, hemostatic agents for bone-bleeding, etc., and has application as an osteoconductive bone grafting material for non-union fractures, periodontal defect fillers, and bony defect fillers (see Col. 4, ll. 25 – 30).
Constanz ‘905 discloses bone-like materials comprising calcium phosphate minerals with added proteins (see Abstract), wherein compositions comprising the materials possess structures analogous to naturally occurring calcium phosphate minerals, including hydroxyapatite (see Col. 2, ll. 59 – 60), wherein the compositions have a wide variety of desirable properties for use in physiological purposes (see Col. 3, ll. 14 – 16), wherein the compositions are suitable for in vivo implantation (see Col. 3, ll. 25 – 32), wherein the compositions may be used as a delivery system for compounds of interest, such as proteins or anti-infective drugs, and may further comprise collagen (see Col. 3, ll. 45 – 60; see also, Example 4, Col. 10), wherein the compositions comprise a physiologically acceptable lubricant, such as water (see Col. 4, ll. 28 – 29), wherein the compositions further comprise bone associated proteins, such as proteoglycans (see Col. 6, ll. 35 – 45), wherein the protein is added to the materials in the form of an aqueous dispersion with a protein concentration of about 1 – 10% wgt (see Col. 7, ll. 28 – 34), and wherein products comprising the compositions may be used for a variety of purposes, such as any form of connective tissue replacement, including bone cement, an injected prosthetic implant, a prosthetic orthopedic or dental implant, as a root canal filler, a prophylactic injection to augment weak osteoporotic bone, or a vehicle for drug delivery (see Col. 8, ll. 3 – 8).
Jie ‘501 discloses a resorbable, macroporous bioactive glass scaffold (see Abstract), and bone graft compositions that include a bioactive glass scaffold (see ¶[0004]), wherein the ideal graft material for hard tissue reconstruction should be (1) highly bioactive, (2) should stimulate the activity of bone forming cells, (3) should possess sufficient mechanical strength to support the filled space, ( 4) function as an osteoconductive scaffold to promote new bone growth to accelerate healing of the defect, and (5) should be resorbed at a rate consistent with the formation of new bone to assure the success of the reconstruction (see ¶[0008]), wherein the bioactive glass may be 45S5 bioglass that contains 45% silica, 24.5% calcium oxide, 24.5% sodium oxide, and 6% phosphate by weight, and is highly bioactive, possessing the fastest biological response when implanted in living tissue among all of the bioactive glasses (see ¶[0009]), wherein the compositions comprise bioactive glass in the form of particles of calcium sodium phosphosilicate and calcium phosphate particles, wherein the calcium phosphate particles are present in the compositions at about 5 to about 95% wgt (see ¶[0052]).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare compositions comprising a dry potassium phosphate-based mixture that comprises MgO, monobasic potassium phosphate, monobasic sodium phosphate, a reabsorbing agent, and a tertiary calcium phosphate, wherein the weight percent ratio of the monobasic potassium phosphate to the magnesium oxide is between about 3:1 and 1:1, and an aqueous solution, wherein the mixture further comprises bioactive glass compositions, and tobramycin, according to the teachings of Diaz ‘124, wherein the composite materials further comprise mineralized collagen material with physical characteristics mimicking the characteristics of bone, with calcium phosphate stably distributed within collagen fibrils to form a substantially uniform composition of calcium phosphate and collagen, with a Ca:P ratio of 1.2 - 1.8, as taught by Constanz ‘169, wherein the compositions comprise proteoglycans that are added to the bone-like materials in the form of an aqueous dispersion with a protein concentration of about 1 – 10% wgt, as taught by Constanz ‘905, and wherein the composite material further comprises a resorbable, macroporous bioactive glass, wherein the bioactive glass may be 45S5 bioglass that contains 45% silica, 24.5% calcium oxide, 24.5% sodium oxide, and 6% phosphate by weight, wherein implant compositions comprise bioactive glass in the form of particles of calcium sodium phosphosilicate and calcium phosphate particles, wherein the calcium phosphate particles are present in the compositions at about 5 to about 95% wgt, and the calcium sodium phosphosilicate is present in amounts from 5 to 95% wgt, according to the teachings of Jie ‘501. One of ordinary skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the express teachings of Constanz ‘169 to the effect that the mineralized collagen can be used for the production of bone fillers, with application as an osteoconductive bone grafting material for non-union fractures, periodontal defect fillers, and bony defect fillers (see Col. 4, ll. 25 – 30), by the teachings of Constanz ‘905 to the effect that the disclosed compositions, further comprising bone associated proteins, such as proteoglycans, have a wide variety of desirable properties for use in physiological purposes (see Col. 3, ll. 14 – 16), such as in vivo implantation (see Col. 3, ll. 25 – 32), and by the teachings of Jie ‘501 to the effect that 45S5 bioglass is highly bioactive, and possesses the fastest biological response when implanted in living tissue among all of the bioactive glasses (see ¶[0009]).
With respect to quantitative limitations directed to the content of proteoglycans in the compositions of the invention recited in claims 1 and 4 – 12, the Examiner notes that the cited references do not disclose ranges of loadings that are exactly congruent with the claimed ranges. However, consistent with the interpretation of claim 2 as set forth above, the proper interpretation of claims 1 and 2, is that the proteoglycan content limitation recited in claim 1 applies to the amount of proteoglycan-loaded mineralized collagen matrix in the claimed composition. Although the cited references do not expressly disclose a relative mass loading for a proteoglycan-loaded mineralized collagen matrix component, it is the Examiner’s position that the proteoglycan solution at 1 – 10% wgt of Constantz ‘905, loaded into the mineralized collagen matrix, would at least overlap with the claimed loadings and, as such, would render the invention obvious. See MPEP § 2144.05. In addition, or in the alternative, it is the Examiner’s position that adjusting the amount and/or concentration of the proteoglycan dispersion, as well as the amount of the protein-loaded mineralized collagen matrix, to read on the limitation in question would amount to nothing more than an optimization of a result-effective variable, the exercise of which is well with the expertise of one of ordinary skill in the appropriate art. Consequently, in the absence of evidence as to the criticality of such parameter, this limitation cannot support patentability. See MPEP § 2144.05 II. A.
The Examiner further notes that Applicants have elected the species of silica bioactive glass from the genus of sodium phosphosilicates as recited in claim 3. The above rejection cites to the teachings of Jie ‘501 directed to the use of 45S5 bioactive glass in bone repair implants. Based on the reference’s explicit teachings as to the composition of 45S5 containing 45% silica, it is the Examiner’s position that 45S5 reads on the elected species, particularly in the absence of any specific definition of the species in Applicants’ specification.
The Examiner further notes that claim 13 recites limitations directed to the “osteoconductive and osteoinductive” properties of the claimed compositions. It is the Examiner’s position that such limitations are directed to functional characteristics of the compositions, which characteristics are inherent to the compositions and that compositions according to the cited art would necessarily exhibit properties reading on the limitations in question. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Further in this regard, the Examiner notes that claim 1 recites a limitation directed to the dry potassium phosphate-based mixture being “configured to be mixed with an aqueous solution.” Such recitation is properly interpreted to be directed to an intended use of the mixture of claim 1, which claim is directed to a composition of matter. Thus, its subject matter must be distinguished from the prior art by its structure or composition, and not how it is used. Cf. Hewlett- Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990) (holding that “apparatus claims cover what a device is, not what a device does.’’). Statements of intended use or function normally are not given patentable weight because they are not structurally limiting. Cf Cochlear Bone Anchored Sols. AB v. Oticon Med. AB, 958 F.3d 1348, 1354-55 (Fed. Cir. 2020) (discussing effect of intended use recitations in claim preamble). However, Diaz ‘124 expressly discloses a composition comprising dry potassium phosphate-based mixture and an aqueous solution (see Abstract), thus reading on the limitation in question.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 1 – 15 would have been obvious within the meaning of 35 USC § 103.
Obviousness-Type 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file-/efs/guidance/eTD-info-I.jsp.
Claims 1 – 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 3, 12 and 13 of U.S. Patent No. 12,357,730 (“the ‘730 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because the enumerated claims are directed to bio-material compositions comprising a dry potassium phosphate based mixture comprising MgO, monobasic potassium phosphate, monobasic sodium phosphate, proteoglycans in an amount between 1 – 5% of the total composition, calcium sodium phosphosilicate, wherein the weight ratio of monobasic potassium phosphate to MgO is between about 3:1 and 1:1, wherein the proteoglycans are selected from the group consisting of mineral-collagen composite matrix, fibers, granules, morcellized fibers, nanoparticles, and combinations thereof, wherein the calcium sodium phosphosilicate is selected from the group consisting of bioactive glass fibers, silica bioactive glass, Silicate, and combinations thereof, wherein the composition further comprises an antibiotic between about 1 - 5 percent of the dry potassium phosphate based mixture, and wherein the antibiotic is an aminoglycoside antibiotic.
Claim 1 of the instant application recites a limitation directed to a loading of proteoglycan at 1 – 10%. Thus, the enumerated claims of the ‘730 patent, although not exactly congruent with the claimed range, significantly overlap with that range, rendering it obvious. See MPEP § 2144.05.
Thus, claims 1 – 3, 12 and 13 of the ‘730 patent are drawn to an invention that reads upon the instant claims and, as such, are directed to an invention that is patentably indistinct therefrom.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). The commonly assigned ‘730 patent, discussed above, may form the basis for a rejection of the noted claims pursuant to 35 U.S.C. §§ 102 or 103 if the commonly assigned case qualifies as prior art pursuant to 35 U.S.C. § 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date pursuant to 35 U.S.C. § 100(i) of the claimed invention.
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In order for the Examiner to resolve this issue the Applicant or patent owner can provide a statement pursuant to 35 U.S.C. § 102(b)(2)(C) and 37 CFR § 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the Applicant or patent owner can provide a statement under 35 U.S.C. § 102(c) and 37 CFR § 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date pursuant to 35 U.S.C. § 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. §§ 102 or 103 based upon the commonly assigned case. Alternatively, applicant may act to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Claims 1 – 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 3, 12 and 13 of co-pending application 19/247,746 (“the ‘746 Application”). Although the conflicting claims are not identical, they are not patentably distinct from each other because the enumerated claims of the ‘746 application are directed to bio-material compositions comprising a dry potassium phosphate based mixture comprising MgO, monobasic potassium phosphate, monobasic sodium phosphate, proteoglycans in an amount between 1 – 5% of the total composition, and calcium sodium phosphosilicate, wherein the weight ratio of monobasic potassium phosphate to MgO is between about 3:1 and 1:1, wherein the proteoglycans are selected from the group consisting of mineral-collagen composite matrix, fibers, granules, morcellized fibers, nanoparticles, and combinations thereof, wherein the calcium sodium phosphosilicate is selected from the group consisting of bioactive glass fibers, silica bioactive glass, Silicate, and combinations thereof, wherein the composition further comprises an antibiotic between about 1 - 5 percent of the dry potassium phosphate based mixture, and wherein the antibiotic is an aminoglycoside antibiotic.
Claim 1 of the instant application recites a limitation directed to a loading of proteoglycan at 1 – 10%. Thus, the enumerated claims of the ‘746 Application, although not exactly congruent with the claimed range, significantly overlap with that range, rendering it obvious. See MPEP § 2144.05.
This is a provisional nonstatutory double patenting rejection.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). The commonly assigned ‘746 Application, discussed above, may form the basis for a rejection of the noted claims pursuant to 35 U.S.C. §§ 102 or 103 if the commonly assigned case qualifies as prior art pursuant to 35 U.S.C. § 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date pursuant to 35 U.S.C. § 100(i) of the claimed invention.
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In order for the Examiner to resolve this issue the Applicant or patent owner can provide a statement pursuant to 35 U.S.C. § 102(b)(2)(C) and 37 CFR § 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the Applicant or patent owner can provide a statement under 35 U.S.C. § 102(c) and 37 CFR § 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date pursuant to 35 U.S.C. § 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. §§ 102 or 103 based upon the commonly assigned case. Alternatively, applicant may act to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Response to Applicants’ Arguments
The Examiner has considered the arguments submitted by Applicants in the Response filed 27 April 2026, but does not find them persuasive. The Examiner first notes that the initial thrust of the arguments is improperly directed to the cited art references taken individually, and not to what the cited references, taken as a whole, would teach or suggest to one of ordinary skill in the art. In this regard, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
More specifically, Applicants also argue that “neither Diaz and Constanz '905 disclose an amount calcium sodium phosphosilicate in the composition as currently claimed [an amount between 1-15% wgt].” However, the new grounds of rejection set forth above cite to the teachings of Jie ‘501 for its disclosures relating to bone repair compositions with scaffolds comprising particles of calcium sodium phosphosilicates, such as 45S5, and particles of calcium phosphates, where the calcium phosphate particles can comprise up to 5 – 95% wgt, leading to a loading of calcium sodium phosphosilicates that read on the limitation at issue.
Further in this regard, Applicants address at length obviousness references that do not contain an express disclosure of a range. However, as addressed immediately above, the rejection now cites to the disclosure of Jie ‘501 for its disclosure of bone repair compositions comprising calcium sodium phosphosilicates at loadings reading on the range now recited in claim 1.
As for the double patenting rejections, Applicants have stated in intent to defer from addressing such rejections until “notification that all other conditions for patentability have been met and the instant claims are otherwise in condition for allowance.” In this regard, a request to hold a matter in abeyance may only be made in response to an OBJECTION or REQUIREMENTS AS TO FORM (see MPEP 37 CFR §§ 1.111(b) and 714.02). Thus, the double patenting rejections of record have been maintained as Applicants have taken no substantive action regarding these rejections at this time. Applicants are reminded that a complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by Applicants showing that the claims subject to the rejection are patentably distinct from the reference claims, or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional. See MPEP 804(I)(B)(1).
Consequently, Applicants’ arguments are unpersuasive and claims 1 – 15 stand rejected pursuant to 35 U.S.C. § 103.
NO CLAIM IS ALLOWED.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
CONCLUSION
Any inquiry concerning this communication or any other communications from the Examiner should be directed to Daniel F. Coughlin whose telephone number is (571)270-3748. The Examiner can normally be reached on M - F 8:30 a.m. - 5:00 p.m.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, David Blanchard, can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/DANIEL F COUGHLIN/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619
Prosecution Insights