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 5 March 2026. Claims 1, 3 – 6, 8 - 17 are amended therein. Claims 1 - 6, 8 – 20, and 22 – 23 are pending, claims 1, 3 – 6, 8 – 17, and 19 are amended, and claims 4, 8, 9, 12 – 19, 22, and 23 remain withdrawn as being directed to a non-elected invention. Consequently, 1 - 3, 5, 6, 10, 11, and 20 are available for substantive examination.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement (IDS’s) filed 5 March 2026, which is now of record in the file.
Claim Objections
The objections to claims 1, 4, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 19 set forth in the Action of 5 December 2025 are hereby withdrawn in light of Applicant’s amendments of the claims.
REJECTIONS WITHDRAWN
Rejections Pursuant to 35 U.S.C. § 112
The rejection of claim 10 pursuant to 35 U.S.C. § 112(d) as set forth in the Action of 5 December 2025 is hereby withdrawn in light of Applicant’s amendment to the claim.
REJECTIONS MAINTAINED
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.
The rejection of claims 1 – 3, 5, 6, 10, 11, and 20 pursuant to 35 U.S.C. § 103, as being obvious over US 2019/0134262 A1 to Deng, M., et al., published 9 May 2019, identified on the Information Disclosure Statement (IDS) filed 4 March 2025, cite no. 1 (USPATAPP) (“Deng ‘262”), in view of WO 2015/092815 A1 to Gurusamy, R. and P. Sankaralingham, published 25 June 2015 (“Gurusamy WO ‘815”), WO 2015/092814 A1 to Gurusamy, R. and P. Sankaralingham, published 25 June 2015, identified on the Information Disclosure Statement (IDS) filed 4 March 2025, cite no. 2 (FOR) (“Gurusamy WO ‘814”), and Annunziata, M., et al., Molecules 22: 2214 (2017) (“Annunziata (2017)”), is hereby maintained.
The Invention As Claimed
Applicant claims a synthetic composite for a bone graft comprising poly(lactic acid), poly(D,L-lactic acid), polypropylene fumarate, and zinc fluorophosphate glass powder, wherein the zinc fluorophosphates glass powder is in the range of 10 to 30% wgt of the composite, wherein the poly(lactic acid) is in the range of 54 to 68% wgt, wherein the poly(D, L-lactic acid) is in the range of 10 to 28% wgt, and wherein the polypropylene fumarate is in the range of 3 to 10% wgt.
The Teachings of the Cited Art
Deng ‘262 discloses a three-dimensional osteomimetic composite porous scaffold comprising poly(lactic acid) (PLA), a bioactive silicate glass (BSG) powder, and poly(propylene fumarate), wherein the bioactive glass component is present in the scaffold at from 2 – 28.6% wgt (see ¶[0004]). The reference does not disclose a composite further comprising poly(D,L-lactic acid), or a composite wherein the bioactive glass is zinc fluorophosphate at 10 to 30% wgt of the composite, the poly(lactic acid) at 54 to 68% wgt, poly(D,L-lactic acid) at 10 to 28% wgt, and polypropylene fumarate at 3 to 10% wgt. The disclosures of Gurusamy WO ‘815, Gurusamy WO ‘814, and Annunziata (2017) remedy those deficiencies.
Gurusamy WO ‘815 discloses that the bioconversion rate of phosphate-based glasses has been improved by the addition of a low, non-toxic concentrations of fluoride salts, such as CaF2 (fluorophosphate glasses), which glasses have better bioconversion rates, the glasses have found limited use due to their high dissolution rate, which rate gives rise to large pH changes, wherein the addition of Group II metal oxide (MgO) in the glass network acts as a network modifier, resulting in altered glass network structure and physico-chemical properties of the glasses, resulting in glasses that can be engineered easily to provide a candidate substrate for synthetic bone graft materials (see p. 3, 1st para.).
Guruswamy WO ‘814 discloses different compositions of zinc-added fluorophosphate glasses (see Abstract), wherein fluorine, when added in low non-toxic concentration to phosphate-based glasses produces fluorophosphate glasses that have a higher bioconversion rate than phosphate glasses, and, to increase the mechanical strength of the fluorophosphate glasses addition of various metal oxides have been used, but, of all the metal oxides, zinc oxide has the unique property of increasing both bioconversion rate as well as mechanical strength (see p. 3, 1st para.), wherein improved bioactivity of phosphate glasses is attained through the addition of fluorine and zinc molecules, producing phosphate glasses with enhanced mechanical strength, load bearing capability, elastic moduli, etc. (see p. 3, 3rd para.), and wherein zinc-modified fluorophosphate glasses can be used for different biomedical applications such as prosthetic implants, stents, screws, plates, tubes, controlled drug delivery, etc. (see p. 4, 2nd para.).
Annunziata (2017) discloses the use of poly-D,L-lactic acid (PDLLA) in dentistry for regenerative procedures in the form of membranes, screws, and pins (see Abstract), wherein polylactic acid (PLA) is a semi-crystalline polymer with molecular weights of 180,000 to 530,000,
a melting point of about 174° C, and glass transition temperature of 57° C, and wherein, by adding D-isomers into an L-isomer based polymerization system of PLA, polymer chains widen and cannot be packed as tightly as PLLA polymer chains so that the resulting material, poly(D,L-lactic acid) (PDLLA), displays biomechanical, thermal, rheological, and biological properties that may be modulated on the basis of the different proportions of L- and D-isomers composing the different PDLLA formulations on the basis that the D-isomer displays a more rapid resorption and a less crystalline structure, while the L-isomer has a higher crystallinity and a less rapid resorption, resulting in an increase of the shear viscosity of the polymer with increasing L-isomer in the L/D-isomer mixture because of the increasing crystallinity of PLA, as well as an increase in the glass transition temperature increase with increasing the amount of the L-isomer (see p. 2, 2nd para.).
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 three-dimensional osteomimetic composite porous scaffold comprising poly(lactic acid) (PLA), a bioactive silicate glass (BSG) powder, and poly(propylene fumarate), wherein the bioactive glass component is present in the scaffold at from 2 – 28.6% wgt, as taught by Deng ‘262, wherein the bioactive glass is a phosphate-based glass that has been improved by the addition of low, non-toxic concentrations of fluoride salts, which glasses have better bioconversion rates, wherein fluorophosphate glasses further comprising MgO, which additive in the glass network acts as a network modifier, resulting in altered glass network structure and physico-chemical properties of the glasses, resulting in glasses that can be engineered easily to provide a candidate substrate for synthetic bone graft materials (see p. 3, 1st para.), as taught by
Gurusamy WO ‘815, wherein fluorine, when added in low, non-toxic concentrations to phosphate-based glasses produces fluorophosphate glasses that have a higher bioconversion rate than phosphate glasses, and, in order to increase the mechanical strength of the fluorophosphate glasses, the addition of various metal oxides have been used, with zinc oxide having the unique property of increasing both bioconversion rate as well as mechanical strength (see p. 3, 1st para.), producing phosphate glasses with enhanced mechanical strength, load bearing capability, elastic moduli, etc., as taught by Gurusamy WO ‘814, and wherein, by adding D-isomers into an L-isomer-based polymerization system of PLA, polymer chains widen and cannot be packed as tightly as PLLA polymer chains so that the resulting material, poly(D,L-lactic acid) (PDLLA), displays biomechanical, thermal, rheological, and biological properties that may be modulated on the basis of the different proportions of L- and D-isomers composing the different PDLLA formulations on the basis that the D-isomer displays a more rapid resorption and a less crystalline structure, as taught by Annunziata (2017). One of skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the express teachings of Guruswamy WO ‘815 to the effect that fluorophosphate glasses further comprising MgO results in altered glass network structures and physico-chemical properties of the glasses, resulting in glasses that can be engineered easily to provide a candidate substrate for synthetic bone graft materials (see p. 3, 1st para.), by the teachings of Guruswamy WO ‘814 to the effect that fluorophosphate glasses, modified by the addition of zinc oxide have the unique properties of increased bioconversion rate as well as increased mechanical strength (see p. 3, 1st para.), producing phosphate glasses with enhanced mechanical strength, load bearing capability, elastic moduli, etc.,, and by the teachings of Annunziata (2017) to the effect that, by adding D-isomers into an L-isomer-based polymerization system of PLA, the resulting poly(D,L-lactic acid) (PDLLA) displays biomechanical, thermal, rheological, and biological properties that may be modulated on the basis of the different proportions of L- and D-isomers composing the different PDLLA formulations on the basis that the D-isomer displays a more rapid resorption and a less crystalline structure.
The Examiner notes that the composite of the claimed invention comprises four components: poly(lactic acid), poly(D,L-lactic acid), polypropylene fumarate, and a zinc fluorophosphate glass. Although the cited references do not disclose all four components in a single composite material, the references reflect the art-recognized functionality that all of these components display osteoconductive and osteoinductive properties that enhance the utility of the compositions when used in bone repair implants or scaffolds. Furthermore, inclusion of poly(D,L-lactic acid) along with poly(lactic acid) provides the skilled artisan with multiple compositional strategies that allow for tailoring of mechanical and in vivo degradation properties, not only by the mixture of the two forms of PLA, but also by optimizing the D- and L-lactide ratios in poly(D,L-lactic acid). The references also clearly disclose that, among the bioactive glasses, zinc-modified fluorophosphate glasses provide additional properties that can be used to easily engineer candidate substrates for synthetic bone graft materials due to zinc oxide having the unique property of increasing both bioconversion rates as well as mechanical strength. It is equally clear from the disclosures of the cited references that relative compositions among the components, as well as the compositional properties of individual properties can all be modified to achieve optimal bone repair results, particularly in terms of degradation rates and biomechanical properties. In light of this, it is the Examiner’s position that selecting relative loadings of the individual components that would read on the relevant claim limitations amounts to nothing more than an optimization of a result-effective variable, consistent with these teachings, 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.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 1 – 3, 5, 6, 10, 11, and 20 would have been obvious within the meaning of 35 USC § 103.
Response to Applicant’s Arguments
The Examiner has considered the Arguments presented in the Response filed 5 March 2026, but does not find them persuasive. With respect to the obviousness rejection of record, Applicant argues that “[t]he materials system exemplified in Deng '262 [the primary § 103 reference] is therefore fundamentally limited to PLGA-silicate glass composites.” Applicant also argues that “Deng '262 does not disclose, suggest, or contemplate a composite comprising PLA, PDLLA, a bioactive polymer selected from polypropylene fumarate or a diester of fumaric acid and propylenediol (1,2-diol), and a bioactive inorganic component consisting of a metal fluorophosphate glass powder, present in an amount of 10-30% w/w of the composite, as presently claimed.” In regard to these arguments, the Examiner would first point out that these deficiencies in the teachings of the primary reference are acknowledged and addressed in the rejection of record. After all, the rejection is an obviousness rejection, and not an anticipation rejection.
The fact that Applicant argues that “[t]he chemical composition and glass chemistry of the inorganic component in Deng '262, namely a silicate-based glass, is entirely distinct from the claimed metal fluorophosphate glass system,” is not determinative of the obviousness analysis. As the rejection of record states, Deng ‘262 is cited on the basis of its teachings directed to a three-dimensional osteomimetic composite porous scaffold comprising poly(lactic acid) (PLA), a bioactive silicate glass (BSG) powder, and poly(propylene fumarate). As further acknowledged, the reference does not explicitly disclose that the poly(lactic acid) is poly(D,L-lactic acid) at 10 to 28% wgt. That deficiency is remedied by the teachings of Annunziata (2017) that poly-D,L-lactic acid (PDLLA) displays biomechanical, thermal, rheological, and biological properties that may be modulated on the basis of the different proportions of L- and D-isomers composing the different PDLLA formulations. Although the primary reference does not disclose the use of zinc fluorophosphate at 10 to 30% wgt, that deficiency is remedied by the teachings of Gurusamy WO ‘815 and Gurusamy WO ‘814 to the effect that, with respect to metal fluorophosphate glasses, the incorporation of Group II metals into flurophosphate glasses results in an altered glass network structure and physico-chemical properties of the glasses, allowing for the production of glasses that can be engineered easily to provide a substrate for synthetic bone graft materials, and that, of all the metal oxides, zinc oxide has the unique property of increasing both bioconversion rate as well as mechanical strength.
As set forth above, Deng ‘262 further teaches that the disclosed scaffold comprises poly(propylene fumarate) at from 2 – 28.6% wgt. The fact that, as Applicant argues, the reference
“is silent with respect to early lamellar bone formation or accelerated bone maturation,” is immaterial to the ultimate question of patentability on the basis that the invention as claimed is directed to a composition of matter, and NOT to a method of use of that composition intended to enhance “early lamellar bone formation or accelerated bone maturation.” However, the fact that Applicant has recognized another advantage that would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). After all, the reason or motivation to modify the primary reference may often suggest what the inventor has done, but for a different purpose, or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by Applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006).
Further with respect to the Guruswamy WO ‘814 reference, Applicant argues that the reference “is entirely silent as to employing the disclosed glass as a component of a composite scaffold or graft material, let alone in combination with PLA, PDLLA, and polypropylene fumarate or fumarate-based diesters, as claimed in the present invention.” However, Applicant’s argument fails to take into consideration the roles of the reference’s teachings in the rejection of record. The rejection does not cite to Guruswamy WO ‘814 for anything but the utility of Group II metal oxides in fluorophosphate glasses in applications directed to bone repair and/or bone growth. Further, it is the Examiner’s position that the teachings of the reference would at least suggest to one of ordinary skill in the relevant art the utility of zinc fluorosilicate glass in bone repair compositions. The fact that, as Applicant argues, the reference discloses a bioconversion period of up to 10 weeks, does not impact the relevance of the reference’s teaching, particularly when the glass species is used in a multicomponent composition, rather then being the only component in a bone repair composition, in comparison to adding the glass to the composition of Deng ‘262.
Applicant also argues against use of the teachings of Guruswamy WO ‘815 on a similar basis as addressed above. However, the same logic applies to this reference as well.
With respect to the disclosures of Annunziata (2017), cited only for disclosure of PDLLA in bone repair applications, Applicant argues that the reference “does not teach that adjusting D/L isomer ratios would yield improved or predictable regenerative outcomes.” However, there is nothing in the reference that would alter the fact that, based on the disclosure of the reference, it would at least be obvious to try the PDLLA component in place of the PLA of Deng ‘262.
Applicant also devotes considerable attention to data provided in the specification that allegedly supports the utility of the claimed invention, and further argues that the data “establish that the claimed composite actively accelerates the bone healing cascade, achieving mature lamellar bone formation in a timeframe not taught or suggested by the prior art.” However, once again, the Examiner notes that there are no limitations recited in the claims at issue that read on the rate at which the composition of the invention achieves “mature lamellar bone formation.”
Consequently, based on the above discussion, Applicant’s arguments are unpersuasive, and claims 1 – 3, 5, 6, 10, 11, and 20 stand rejected pursuant to 35 U.S.C. § 103.
NO CLAIM IS ALLOWED.
THIS ACTION IS MADE FINAL. Applicants are reminded of the extension of time policy as set forth in 37 CFR § 1.136(a).
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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 Response 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 extension fee 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
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