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 . Claims included in the prosecution are claims 1-20.
Applicants' arguments, filed 08/21/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 8 and 15 recite wherein said spherical particles partially flattened by compression are formed by a process comprising…and combining a biocompatible polymer with said partially flattened spherical particles to form said intermediate material. The claims are indefinite since the claims recite a process of forming spherical particles partially flattened by compression and the step of combining a biocompatible polymer with said partially flattened spherical particles is not a process step for forming spherical particles partially flattened by compression.
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 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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Morrissette et al. (US 2009/0222091, Sep. 3, 2009) (hereinafter Morrissette) in view of Erbe et al. (US 2017/0112959, Apr. 27, 2017) (hereinafter Erbe) and O’Gara (US 2012/0288441, Nov. 15, 2012), as evidenced by Samish et al. (WO 2025/191570 A1, Sep. 18, 2025) (hereinafter Samish).
Morrissette discloses a first material, such as PEEK (i.e., biocompatible polymer), in the form of flakes or powder, mixed with a sufficient amount of a second particulate material which is removable from the first material at a subsequent act (i.e., an intermediate material) to reveal a porous structure. The second material is a dissolvable material, such as course table salt (NaCl) (i.e., fugitive material) having a granule diameter of greater than 180 microns, preferably between about 300 and 710 microns (¶ [0020]). The salt is dissolvable in water (¶ [0029]). The resultant porous PEEK material is suitable for implant (¶ [0031]). PEEK is a rigid biocompatible polymer (abstract). The polymer has a porosity of between 50% and 85% by volume (¶ [0006]).
Morrissette differs from the instant claims insofar as not disclosing wherein the salt (NaCl) is spherical.
However, Erbe discloses wherein the selection of the particle size, shape and distribution of a leachate fugitive component is key to controlling the microstructure and nature of interconnected porosity and resulting microenvironment for bone formation (¶ [0030]). The shape of voids is controlled by the choice of fugitive phase particle size and shape distribution, as is the interconnectedness of the resulting pore network. Rounded, spherical fugitive particles are typical, but oval, elliptical, cylindrical (rounded geometry) particle shapes may also be beneficial, especially compared to square or sharp-edged configurations that are typically less desirable for most cellular microenvironments, attachment, and physiologic fluid flow (¶ [0017]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the salt (NaCl) of Morrissette to be spherical since spherical is a known and effective shape for a dissolvable material and such shape does not have any edges, thus making such shape more desirable for creating pores for cellular microenvironments, attachment, and physiologic fluid flow as taught by Erbe.
The combined teachings of Morrissette and Erbe do not teach wherein the salt (NaCl) is partially flattened.
However, O’Gara discloses injectable particles that are substantially spherical, for example, having the form of an oblate spheroid (a slightly flattened sphere) (¶ [0028]).
As discussed above, it would have been obvious to have formulated the salt (NaCl) to be spherical. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have used specifically oblate spheroid particles as the particulate material since this is a known and effective type of spherical shape in the art as taught by O’Gara.
Regarding instant claims 1, 8 and 15 reciting wherein the spherical particles are partially flattened by compression formed by a process comprising compressing spherical particles to render partially flattened spherical particles, this is a product-by-process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See MPEP 2113. In the instant case, the claimed partially flattened spherical particle is obvious from O’Gara; therefore, the claim is unpatentable even though O’Gara does not disclose forming the partially flattened spherical particle by compression.
Regarding instant claims 4, 11 and 18 reciting wherein a volume of said fugitive material is between 50% and 85%, Morrissette discloses wherein the polymer has a porosity of between 50% and 85% by volume and wherein dissolution of the table salt creates the pores. Therefore, it would have been obvious to one of ordinary skill in the art that the table salt (i.e., fugitive material) is present between 50% and 85% in order for there to be a porosity of between 50% and 85%.
Regarding instant claims 7 and 14 reciting wherein the fugitive material is bioactive, as evidenced by Samish, sodium chloride (NaCl) is a bioactive compound (page 11, last paragraph).
Response to Arguments
Applicant argues that Morrissette and Erbe do not disclose or suggest forming a coalesced fugitive-particle mass before introducing the polymer. The amended claims require a mass of compressed particles formed from spherical particles with a plurality of those particles coalesced with one another before the polymer is combined with the fugitive material.
The Examiner does not find Applicant’s argument to be persuasive. The claims do not recite a coalesced fugitive-particle mass. The claims recite compressing spherical particles to render partially flattened spherical particles. Spherical particles may be compressed one by one to be rendered partially flattened. There is nothing recited in the claims to require the spherical particles to be compressed together such that they coalesced into a mass. Also, the independent claims recite a fugitive material suspended or dispersed in said polymer and comprising spherical particles. A coalesced fugitive-particle mass would go against particles being suspended or dispersed in a polymer. Also, a coalesced fugitive-particle mass would go against the fugitive material comprising particles. Therefore, since the claims do not require a coalesced fugitive-particle mass before introducing the polymer, it is not necessary for the prior art to teach this. As such, Applicant’s argument is unpersuasive.
Conclusion
Claims 1-20 are rejected.
No claims are 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY LIU whose telephone number is (571)270-5115. The examiner can normally be reached Mon-Fri 9 am - 5 pm.
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/TRACY LIU/Primary Examiner, Art Unit 1614
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