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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/15/25 has been entered.
Claim Status
Claims 2, 4, 5, 12 and 14-17 have been cancelled.
Claims 1, 3, 6-11, 13, 18-20 are pending.
Claims 13 and 19 are withdrawn.
Claims 1, 3, 6-11, 18 and 20 are under examination.
Withdrawn rejections
Applicant's remarks filed 9/15/25 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
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, 3, 6-11, 18 and 20 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.
Determining the adequacy of a written description "requires an objective inquiry into the four comers of the specification from the perspective of a person of ordinary skill in the art." Id. Thus, "[I]psis verbis disclosure is not necessary to satisfy the written description requirement of Section 112." Fujikawa v. Wattanasin, 93 F.3d 1559, 1570 (Fed. Cir. 1996).
In the instant case, 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 introduces new matter as the claim recites the limitation: "wherein the biomaterial is free of microparticle releasing growth factors”. This is properly interpreted as an exclusionary proviso/negative limitation with no support in the specification for this limitation. See MPEP 2173.05(i): “Any negative limitation or exclusionary proviso must have basis in the original disclosure…The mere absence of a positive recitation is not basis for an exclusion.” The limitation was not described in the specification as filed, and person skilled in the art would not recognize in the applicant’s disclosure a description of the invention as presently claimed. MPEP 2163.06(I) states: “Applicant should therefore specifically point out the support for any amendments made to the disclosure.” Applicant has not directed the Examiner to the support in the specification for the amendments. Therefore, it is the Examiner’s position that the disclosure does not reasonably convey that the inventor had possession of the subject matter of the amendment at the time of filing of the instant application.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3, 10 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dang et al. (Tissue Engineering: Part A; 2014, volume 20(23 and 24): pages 3163-3175; hereinafter Dang2014).
Regarding claims 1, 3, 10 and 11, Dang2014 disclose 3D, which the Examiner interprets to mean three dimension, hASC constructs incorporated gelatin microspheres loaded with and without transforming growth factor-b1 (TGF-b1) (Abstract; Page 3165, right column Microsphere-incorporated hASC aggregate formation: “Varying amounts of microspheres with or without TGF-b1 were suspended in chemically defined medium with P3 cells”). Dang2014 report that: “The C-6-S staining serves as additional evidence that the hASCs within this system were able to undergo chondrogenesis and produce proteoglycan-rich ECM.” ((Page 3171, right column 3rd paragraph). Consequently, a biomaterial having multi-dimensional structure comprising osteogenic differentiated adipose-derived stem cells (ASCs), a biocompatible gelatin microsphere material without releasing growth factors and an extracellular matrix is disclosed by the reference. Since the materials as the same as claimed, then the biomaterial of Dang2014 also secretes at least 20 ng of OPG per g of biomaterial and at least about 10 ng of VEGF per g of biomaterial. The Examiner's finding is based on the principle that products of identical chemical compositions cannot have mutually exclusive properties. This is a well settled principle in patent law. See In re Papesch, 315 F.2d 381,391 (CCPA 1963) ("From the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing."). Where patentability rests upon a property of the claimed material not disclosed within the art, the USPTO has no reasonable method of determining whether there is, in fact, a patentable difference between the prior art materials and the claimed material. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Therefore, where the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the USPTO can require an applicant to prove that the prior art products do not necessarily possess the characteristics of his claimed product. Id.
Claim Rejections - 35 USC § 103
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 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.
Claims 1, 3, 6-8 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Dang et al. (STEM CELLS TRANSLATIONAL MEDICINE 2017;6:1644–1659) and Dang et al. (Tissue Engineering: Part A; 2014, volume 20(23 and 24): pages 3163-3175; hereinafter Dang2014).
Applicant claims, for example:
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Claim interpretation: The limitation of “osteogenic differentiated adipose-derived stem cells” refers to osteogenic osteoblast cells (Specification page 11, paragraph 5). The limitation of “at least 20 ng of OPG per g of biomaterial” is an indirect measurement of the number of osteoblast cells which secrete OPG.
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 1, 3, 6 and 8, Dang et al. teach a scaffold-free cell system for controlled growth factor delivery from incorporated microparticles (Title; Abstract; Statement of Significance) where the progenitor cells/hMSCs directly differentiate into osteoblasts (Introduction page 1644; page 1645, 2nd paragraph) and the authors took advantage of the cell’s natural ability to produce tissue-specific ECM and added hydroxyapatite microparticles (Page 1645, left column, 2nd paragraph; page 1646, Microparticle Production/Scaffold-Free Construct Production), which are microparticles of a calcium phosphate. As shown in Figure 1A below, Dang et al. pictorially represent their system with particles sounded by cells/matrix, which looks just like Applicant’s provided in the Declaration filed 8/26/22. Dang et al. provide Figure 1A2 shows a biomaterial embodiment that is free of microparticles that release growth factors because the microparticles are empty.
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Declaration Figure 1 (page 3 filed 8/26/22) shows particles being added to cells:
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Similarly, Dang et al. first grow cells and then add particles of GM or MCM with or without growth factors to the passage 3 hMSC cells (Page 1646, Scaffold-Free Construct Production). Consequently, a biomaterial free of microparticles releasing growth factors is provided and is the same order of steps taken by Applicant that follows an osteogenic pathway. By Applicant’s and the Declarant’s own admissions (See discussion below), the embodiment without growth factors of Dang et al. leads to a secondary extracellular matrix that is capable of secreting high amounts of OPG. There is no difference in the process step order and the same process steps will produce the same product that produces high amounts of OPG.
Regarding claim 11, the constructs of Dang et al. are 3D (Figure 1B).
Regarding claim 1, Dang2014 teaches using osteogenic differentiated adipose-derived stem cells in the scaffold-free construct (Abstract).
Level of Ordinary Skill in the Art
(MPEP 2141.03)
The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a tissue engineering research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from tissue engineering, cell biology, materials science, and have expertise in stem cells, cell-matrix interactions and cell differentiation— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
and
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Dang et al. is that Dang et al. do not expressly teach that osteogenic differentiated adipose-derived stem cells or wherein the biomaterial secretes at least 20 ng of OPG per gram of biomaterial. However, as discussed above, the differentiated adipose-derived stem cells can be osteoblasts and how the osteoblasts are provided to the biomaterial is interpreted as a product-by-process type limitation. So, whether the osteoblasts are derived from differentiated ASCs or some other progenitor cell is all the same to the Examiner as the result is the same. An osteoblast is an osteoblast and will function as an osteoblast. In an alternative interpretation, Dang2014, who is the same scientist in Dang et al., knows hASCs can be employed in the construct. It is merely using one functional equivalent or another for the same function. “Where two known alternatives are interchangeable for a desired function, an express suggestion to substitute one for the other is not needed to render a substitution obvious." In re Fout 675 F.2d 297, 301 (CCPA 1982). Thus, employing osteogenic differentiated adipose-derived stem cells (ASCs) is obvious over the combined references. Accordingly, there is no difference in the process step order and the same process steps will produce the same product that produces high amounts of OPG. Furthermore, since Dang et al. teach providing the osteogenic biomaterial with particles of hydroxyapatite, then production of at least 20 ng of OPG per gram of biomaterial is either implicit in the scaffold-free construct of Dang et al. or readily optimized by increasing the number of osteoblasts that produce OPG in the scaffold-free construct, which would be important in the repair of bone defects and accelerate endochondral ossification as taught by Dang et al. It appears that Applicant has merely measured the amount of OPG produced by the scaffold free construct of Dang et al. See MPEP 2145(II): Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In fact, Applicant measured the amount of OPG produced from biomaterials with hydroxyapatite (HA) particles, which is what Dang et al. employed, and found about 76 ng/g biomaterial (Specification page 60, Osteoclastic activity).
The difference between the instant application and Dang et al. is that Dang et al. do not expressly teach wherein the particles of calcium phosphate have an average size ranging from about 50 μm to about 1500 μm. However, Dang et al. do teach using GM particles of average diameter 60.9 ± 50.1 microns to provide a range of 10.8 to 111 microns, which overlaps the claimed range, and suggest that the average diameter of the hydroxyapatite particles is 3.41 ± 1.04 microns (Page 1646, left column, Microparticle Production). Making the hydroxyapatite calcium phosphate containing particles larger does not appear to have any criticality and would be obvious to the ordinary artisan in this art given that larger GM particles that overlap the claimed range are used with success. From MPEP 2144.05 (II) (A): “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)…see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.").
The difference between the instant application and Dang et al. is that Dang et al. do not expressly teach wherein the biomaterial comprises at least about 10 ng of VEGF per g of biomaterial. However, Dang et al. suggest that the cells arising from the process secrete angiogenic factors like VEGF (Page 1657, left column 2nd paragraph) and the osteoblasts of Dang et al. naturally produce VEGF. It is merely measuring how much was produced in the scaffold free construct of Dang et al. and optimized by increasing the number of osteoblasts that produce VEGF. See MPEP 2145(II): Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979).
Response to Declaration
The Declaration filed 9/15/25 by Professor Dr. Denis Dufrane has been carefully considered but is not persuasive. The Declarant states that Dang requires growth factor releasing microparticles and the present invention does not. Respectfully, the Examiner has a different perspective. As discussed above, Dang provides embodiments where the microparticles are empty. Thus, there are no growth releasing factors in the microparticles in that embodiment. While the Examiner acknowledges the passages cited by Applicant, the Examiner also points out that the particles of GM or MCM are “with or without” loaded TGF-β1 and BMP-2, respectively, as highlighted by the Examiner below.
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The embodiments without the growth factors reads on what the Declarant and Applicant allege is an “osteogenic differentiation medium” as opposed to a chondrogenic differentiation medium containing TGF-beta (Comparative Table 1 of the Declaration).
The Declarant comments on the chondrogenic markers on page 3 of the Declaration but provides no further analysis as to why that is important.
On page 4 of the Declaration, the Declarant asserts that the biomaterial of the instant invention differs through the production process step order and the obtained secretion/release profile from Dang. In the comparative table 1, the Declarant emphasizes that in the process of Dang, the cells incorporate the microparticles and have no or unsubstantial osteoprotegerin and in contrast the cells do not incorporate the microparticles in the biomaterial claimed and produce high amounts of osteoprotegerin. This comparative table is unavailing. In Applicant’s Example 1, Applicant grew and expanded human adipose derived stem cells for multiple passages and then sprinkled biocompatible materials onto the cells when they reached confluence to produce a morphologic change. Sprinkling of the biocompatible material naturally incorporates the biocompatible material into the biomaterial despite the Declarant’s assertions. Similarly, Dang et al. grew and expanded hMSCs and microparticle incorporated hMSC sheets of passage 3 hMSCs were produced by mixing the hMSCs with biocompatible materials (GM (gelatin) or MCM (hydroxyapatite)), hence seeding the microparticles onto the differentiated cells, with or without growth factors, and allowed to self-assemble for 2 days. Applicant’s differentiation medium contained DMEM supplemented with dexamethasone, ascorbic acid and sodium phosphate. Dang et al. also expanded the hMSCs in DMEM medium (Materials and Methods hMSC Isolation and Expansion) and the basal medium used for construct production contained DMEM, dexamethasone, ascorbic acid and phosphate (Scaffold-Free Construct Production). The order of steps as taken by Dang et al. is the same as taken by Applicant. The Declarant’s arguments are not persuasive.
On page 5 of the Declaration, the Declarant states that osteoblasts are the primary and functionally essential source of OPG in bone. The Declarant asserts that the higher level of OPG is due to the osteogenic differentiation medium as opposed to a chondrogenic medium, which the Declarant has clarified as meaning in the absence of growth factors (Table 1: “a chondrogenic (TGF-beta) differentiation medium”). Since Dang et al. provide embodiments without growth factors, then by the Declarants own reasoning those contain an osteogenic differentiation medium that will naturally lead to higher levels of OPG. And Dang et al. teach an expectation that the hMSCs will differentiate into osteoblasts (Page 1645, right column 2nd paragraph). None of the Declarants arguments or assertions are persuasive.
Response to Arguments: Applicant’s arguments filed 9/15/25 have been carefully considered but are not persuasive.
On page 5 of remarks, Applicant refers to the Declaration and alleges the process of Dang et al. is entirely different. However, Applicant’s position is fatally flawed because Dang et al. provide embodiments without added growth factors. The Examiner has shown above in the rejection and response to the Declaration that Dang et al. provide embodiments without growth factors and is the same order of steps taken by Applicant that follows an osteogenic pathway. By Applicant’s and the Declarant’s own admissions, the embodiment without growth factors of Dang et al. leads to a secondary extracellular matrix that is capable of secreting high amounts of OPG. There is no difference in the process step order and the same process steps will produce the same product that produces high amounts of OPG whether Dang et al. recognized this latent benefit or not because it naturally flows from the disclosure of Dang et al. Applicant and the Declarant have failed to provide any objective evidence to the contrary nor any evidence that an osteoblast derived from one cell line is any different from an osteoblast derived from another cell line. An osteoblast is an osteoblast and will function as an osteoblast. Please note MPEP 2145(II): “Prima Facie Obviousness Is Not Rebutted by Merely Recognizing Additional Advantages or Latent Properties Present But Not Recognized in the Prior Art
Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979).” In fact, the only objective evidence in this record supports the Examiner’s position. Applicant measured the amount of OPG produced from biomaterials with hydroxyapatite (HA) particles, which is what Dang et al. employed, and found about 76 ng/g biomaterial (Specification page 60, Osteoclastic activity).
Also note MPEP 2112 II: “II. INHERENT FEATURE NEED NOT BE RECOGNIZED AT THE TIME OF THE INVENTION
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003).”
Applicant’s arguments are not persuasive.
Claims 7, 8, 9, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Dang et al. (STEM CELLS TRANSLATIONAL MEDICINE 2017;6:1644–1659) and Dang et al. (Tissue Engineering: Part A; 2014, volume 20(23 and 24): pages 3163-3175; hereinafter Dang2014), as applied to claims 1, 3, 6-8 and 10-11 above, in further view of Alsberg, E (US20140186952) and McKay, WF (US 6039762) and Lynch, KL (US 5306303).
Applicant claims:
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Dang et al. and Dang2014 are discussed in detail above and that discussion is incorporated by reference.
The difference between the instant application and Dang et al. as modified by Dang2014 is that Dang et al. as modified by Dang2014 do not expressly teach wherein the particles of calcium phosphate are particles of hydroxyapatite (HA) and/ or β-tricalcium phosphate (β-TCP) or wherein the particles of calcium phosphate have an average size ranging from about 50 μm to about 1500 μm or wherein the particles of calcium phosphate are particles of HA/β-TCP in a ratio ranging from 10/90 to 90/10. This deficiency in Dang et al. as modified by Dang2014 is cured by the teachings of Alsberg, McKay and Lynch.
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to modify the scaffold free construct of Dang et al. as modified by Dang2014 wherein the particles of calcium phosphate are particles of hydroxyapatite (HA) and/or β-tricalcium phosphate (β-TCP) or wherein the particles of calcium phosphate are particles of HA/β-TCP in a ratio ranging from 10/90 to 90/10, as suggested by Alsberg and McKay and produce the instant invention. As discussed above, Dang et al. teach and suggest calcium phosphate containing hydroxyapatite. Alsberg teaches a similar self-assembled scaffold-free construct (Claim 1) made in a method of forming a cell aggregate construct by isolating undifferentiated and/or substantially differentiated progenitor cells; expanding the undifferentiated and/or substantially differentiated progenitor cells; combining the undifferentiated and/or substantially differentiated progenitor cells with a plurality of the nanoparticles and/or microparticles so that the nanoparticles and/or microparticles are dispersed and suspended with the undifferentiated and/or substantially differentiated progenitor cells in a culture medium; and culturing the suspension of nanoparticles and/or microparticles and undifferentiated and/or substantially differentiated progenitor cells so that an cell aggregate is formed that can be readily manipulated and formed into tissue constructs with defined architectures (Claim 26) where the progenitor cells can be isolated form adipose tissue (Claim 11) and the nanoparticles/microparticles can be about 1 nm to about 200 microns (Claim 17), be made of hydroxyapatite, tricalcium phosphate and mixtures thereof [0068] and can improve spatial distribution of ECM [0121]. McKay teach the artisan that biphasic calcium phosphate composites are preferred for optimal bone ingrowth and strength where the biphasic composites may include from about 10% to about 90% hydroxyapatite and about 90% to about 10% by weight of a resorbable calcium phosphate. McKay teach that the ratio of HA/TCP affects the rate of biodegradability. Hydroxyapatite provides strength but it is slowly degraded. β-tricalcium phosphate is relatively weak and rapidly degraded. HA/TCP biphasic ceramics may include from about 10% to about 90% hydroxyapatite and from about 90% to about 10% tricalcium phosphate by weight (column 5, lines 10-33). Accordingly, the ordinary artisan would be motivated to employ the HA/TCP as suggested by Alsberg or McKay for those desirable properties and have a reasonable expectation of success in using particles of hydroxyapatite (HA) and/ or β-tricalcium phosphate (β-TCP) and wherein the particles of calcium phosphate are particles of HA/β-TCP in a ratio ranging from 10/90 to 90/10 in the scaffold free construct of Dang et al.
McKay also directs the artisan to Lynch US 5306303 for HA/β-TCP biphasic ceramics (column 5, lines 17-20). Lynch teaches the artisan to use particles of 60% HA and 40% β-TCP of 0.5-1.0 mm in size mixed with collagen to make osteoinductive implants (column 3, lines 36-49; column 4, lines 27-30). While Dang et al. average diameter is 3.41 ± 1.04 microns (Page 1646, Microparticle Production), McKay and Lynch renders obvious a larger particle size of 0.5-1.0 mm, which falls within the claimed range of about 50 microns to about 1500 microns. Accordingly, the ordinary artisan would have a reasonable expectation of success in using calcium phosphate particles of about 50 microns to about 1500 microns in the scaffold free construct of Dang et al. as modified by Dang2014 in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments: Applicant’s arguments filed 9/15/25 have been carefully considered but are not persuasive.
Applicant first asserts that the comments above apply here because Dang et al. is applied above as well. Respectfully, Applicant’s arguments were not persuasive above and remain unpersuasive here.
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 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, 3, 6-9, 11, 18 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of US Patent 11602579. The instant application and the patent have the same inventive entity and the same assignee. Although the claims at issue are not identical, they are not patentably distinct from each other because patent also discloses a 3D osteoinductive biomaterial/medical device that secretes at least about 10 ng OPG per g of biomaterial, which range encompasses the claimed range of at least about 20 ng of OPG per g of biomaterial, comprising:
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No microparticle releasing growth factors is present.
The patent does not expressly teach the particle size of the calcium phosphate HA/ β-TCP has an average size ranging from about 50-1500 microns. However, determining the size of the particles used by the patent is nothing more than optimizing the size of the particles for use in the biomaterial and measuring their average size.
The patent does not expressly teach wherein the biomaterial comprises at least about 10 ng of VEGF per g of biomaterial. However, the proliferated differentiated cells would produce the same amount of VEGF in the biomaterial.
Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patented subject matter.
Response to Arguments:
Applicant asserts that “Independent claim 20 is directed to a material whereas the claims of U.S. Patent No. 11,602,579 are directed to a material produced by a claimed method.” Respectfully, Applicant’s argument makes no sense because it ignores independent claim 1 and the patent claims a three-dimensional biomaterial, which is a composition of matter, and the instant claims are also directed to a biomaterial having a multi-dimensional structure, which is also a composition of matter. Applicant has not pointed out any structural non-obvious difference between the biomaterials. Applicant’s arguments are not persuasive.
Claims 1, 3, 6-9, 11, 18 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10-12, 16-20 of copending Application No. 16646755. The instant application and the copending application have the same inventive entity and the same assignee. Although the claims at issue are not identical, they are not patentably distinct from each other because copending application also discloses a 3D osteoinductive biomaterial/medical device where osteogenic cells synthesize extracellular matrix and secrete at least about 5 ng or 10 ng OPG per g of biomaterial, which range encompasses the claimed range of at least about 20 ng of OPG per g of biomaterial and at least about 10 ng of VEGF per gram of biomaterial comprising:
Osteogenic differentiated ASCs;
Extracellular matrix;
Calcium phosphate particles of HA/β-TCP in a ratio ranging from 10/90 to 90/10 with an average size ranging from about 50-1500 microns.
No microparticle releasing growth factors is present.
Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments: Applicant asserts that as amended claim 1 Is not obvious. However, the Examiner has shown that the amended claim 1 limitation is present. Applicant respectfully submits that the resolution of this issue should be deferred until the scope of allowable claims is agreed-upon. Until that time, the rejections are maintained.
Conclusion
Applicant’s and the Declarant’s arguments are fatally flawed because Dang et al. do teach embodiments without growth factors, which the Declarant has admitted is an osteogenic medium that results in higher OPG production. No claims are allowed
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613