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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-5, in the reply filed on 7/9/2026 is acknowledged.
Claims 6-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/6/2026.
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.
Claim 4-5 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.
Claim 4 recites “wherein said method further comprises applying said first set or process parameters to said second region” and claim 5 recites “wherein said method comprises applying said second set of process parameters to said first region.” However, claim 1, from which claims 4 and 5 respectively depend, require “utilizing a first set of process parameters to fabricate said first region and a second set of process parameters to fabricate said second region.” Therefore, if the first set of process parameters must be used to form the first region it is unclear how the second set of process parameters may be applied to it and what would result from such a step. Likewise, if the second set of process parameters must be used to form the second region it is unclear how the first set of process parameters may be applied to it and what would result from such a step. As a result, claims 4 and 5 are indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4-5 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 4 recites “wherein said method further comprises applying said first set or process parameters to said second region” and claim 5 recites “wherein said method comprises applying said second set of process parameters to said first region.” However, claim 1, from which claims 4 and 5 respectively depend, require “utilizing a first set of process parameters to fabricate said first region and a second set of process parameters to fabricate said second region.” As the first region and second region already have respectively defined corresponding first and second process parameters, the limitations of claim 4 and 5 are considered to fail to include all of the limitations of the claim upon which they depend and are therefore, in improper dependent form.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Interpretation
Claim 1 recites “a composite structure.” Paragraph 15 of the instant specification states “The spatially controlled structure may be referred to herein as a “composite structure” which means that there are multiple distinct regions within the structure. In some embodiments, the composite structure contains one solid region and one porous region. The composite structure may be a matrix-inclusion composite, such as one containing porous prismatic elements (e.g., cylinders or rectangular slots) throughout an otherwise-solid matrix.” Therefore, the term “composite structure” is interpreted in light of Applicant’s specific definition as including a structure having multiple distinct regions in the structure, for example, regions of differing porosity.
Claim 1 also recites the term “build volume.” The instant specification does not appear to define the term. As the claim requires introducing material into, and removing material from, the build volume it is interpreted as drawn to the space/area in which the additive manufacturing step takes place.
Claim 3 recites “said first region and said second region are fabricated simultaneously.” The term “simultaneously” is interpreted to include wherein the first and second regions are formed as part of the same process or step (e.g. both formed along a single layer) and does not necessarily require that the they are fabricated at the exact same instance in time (e.g. using multiple fabricating devices each fabricating a respective region).
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.
Claim(s) 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over O’Neill et al. (US 11510783).
With respect to Claim 1, O’Neill teaches a method of making an architected material with regions having different porosities, and thus, different permeabilities, the method comprising defining a structure to be fabricated, wherein the structure contains a first region and a second region having different porosity characteristics, and thus, constituting a “composite structure” as instantly claimed, dispensing a powder build material for additive manufacturing on a substrate or platform (i.e. introducing an additive-manufacturing feedstock to a build volume), additively manufacturing using, for example, selective laser sintering, to form an architected material using a first set of process parameters to fabricate a first region having a first porosity and pore size and a using a second set of parameters to form the second region, wherein the first region and second region each may have a first pore size of 80-800 microns, and wherein the structure may comprise various degrees of porosity. (col. 1, ln. 31 to col. 2, ln. 13; col. 2, ln. 53 to col. 4, ln. 28; col. 17 ln. 31 to col. 18, ln. 24; col. 35, ln. 38-46).
Thus, O’Neill teaches additively manufacturing an architected material having at least a first region having a pore size overlapping the instantly claimed range and wherein a second region may have a porosity and pore size exceeding the first region. It follows that the first and second region, having differing porosity and pore size would also have first and second average permeability, wherein the first region may comprise a lower average permeability than the second region. See also MPEP 2112.01; 2144.05.
In particular, the reference teaches adjusting laser scanning parameters to tailor the porosity and pore size of the additively manufactured structure. (see, e.g., col. 5, ln. 1-5; col. 16, ln. 10-4; col. 17 ln. 31 to col. 18, ln. 24). Finally, one of ordinary skill in the art would recognize that the additive manufacturing method of O’Neill, comprising for example selective laser sintering, would require removing the additively formed structure from the manufacturing apparatus for subsequent use. Accordingly, it would have been obvious to one of ordinary skill in the art to recover the architected material taught by O’Neill from the build volume in order to use, store, or otherwise process the manufactured architected material/structure.
Additionally, it would have been obvious to one of ordinary skill in the art to select from the portion of the overlapping ranges. Overlapping ranges, in particular, where the ranges of a claim overlap with the ranges disclosed in the prior art, have been held sufficient to establish a prima facie case of obviousness. MPEP § 2144.05.
With respect to Claim 2, O’Neill teaches wherein the additive manufacturing feedstock, may be metal or metal alloy useful for forming a medical implant, and thus, deemed to also constitute a “biological material.” (col. 3, ln. 4-25; col. 4, ln. 29-36).
With respect to Claim 3, O’Neill teaches a method of additively manufacturing the architected material in a layer-by-layer process and teaches examples wherein first and second regions exist along one or more of planes suitable for additive manufacturing (see, e.g., Fig. 50B). Accordingly, it would have been obvious to one of ordinary skill in the art to fabricate the first and second regions simultaneously, in order to carry out the method of O’Neill and form an additively manufactured architected material as detailed above.
With respect to Claims 4-5, O’Neill teaches controlling the process parameters, including laser power, scanning speed, spacing, etc. to control the porosity and pore size of selected regions of the architected material. (see rejection of claim 1; see, e.g., col. 5, ln. 1-5; col. 16, ln. 10-4; col. 17 ln. 31 to col. 18, ln. 24; col. 12, ln. 1-61). The reference teaches ability to achieve desired properties (including pore size) with other parameters and teaches examples wherein one or more parameters such as laser power and pulse repetition rate are maintained to achieve different results. (col. 18, ln. 24; col. 12, ln. 1-61. Thus, at least one process parameter applied to the first region (e.g. laser power) may be applied to the process parameters of the second region and at least one process parameter for the second region (e.g. laser repetition rate) may be applied to the first region to obtain the method and results disclosed by O’Neill with a predictable result of success and meeting the instantly claimed limitations.
Claim(s) 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Holmes (US 2021/0298908).
With respect to Claim 1, Holmes teaches a method of making an architected material/component with regions having different porosities, and thus, different permeabilities, the method comprising defining a structure to be fabricated, wherein the structure contains a first region and a second region having different porosity characteristics, and thus, constituting a “composite structure” as instantly claimed, providing a build material to an additive manufacturing device (i.e. introducing an additive-manufacturing feedstock to a build volume), additively manufacturing using a layer-by-layer technique to form an architected material using a first set of process parameters to fabricate a first region having a first porosity and pore size and a using a second set of parameters to form the second region, wherein the first region may have a first pore size of 0-50 microns, and wherein the second region has a second pore size, larger than the first pore size, of 100-200 or 500 microns to 1 mm (wherein the reference teaches second and third pore sizes, either which of may constitute a “second” as related to the instant claims). (para. 2, 52, 56, 58, 61, 75-78, 82, 126, 161-162). Holmes teaches a plurality of regions having differing porosity including the number and size of pores. (para. 161-162).
Thus, Holmes teaches additively manufacturing an architected material having at least a first region having a pore size overlapping the instantly claimed range and wherein a second region may have a porosity and pore size exceeding the first region. It follows that the first and second region, having differing porosity and pore size would also have first and second average permeability, wherein the first region may comprise a lower average permeability than the second region. See also MPEP 2112.01; 2144.05.
In particular, Holmes teaches wherein the additive manufacturing may comprise SLA or SLS techniques, comprising a powder or resin feedstock heated with a laser, and wherein the additive manufacturing apparatus parameters are adjusted to achieve the architected structure described above. (para. 172-174). Accordingly, it would have been obvious to one of ordinary skill in the art to carry out the conventional steps of a technique such as SLS comprising providing the feedstock to a build volume, adjusting the processing parameters to obtain a predetermined structure, and recovering the manufactured structure from the build volume, in order to additively manufacture and obtain a component with the predetermined structure and properties according to its intended purpose.
Additionally, it would have been obvious to one of ordinary skill in the art to select from the portion of the overlapping ranges. Overlapping ranges, in particular, where the ranges of a claim overlap with the ranges disclosed in the prior art, have been held sufficient to establish a prima facie case of obviousness. MPEP § 2144.05.
With respect to Claim 2, Holmes teaches wherein the additive manufacturing feedstock, may be a polymer useful for forming a medical implant, and thus, deemed to also constitute a “biological material.” (abstract; para. 62, 164, 166-168).
With respect to Claim 3, Holmes teaches a method of additively manufacturing the architected material in a layer-by-layer process that forms both the first and second regions (see rejection of claim 1 above and therefore, is deemed to meet the instant claim. Furthermore, it would have been obvious to one of ordinary skill in the art to fabricate the first and second regions simultaneously, in order to carry out the method of Holmes in an efficient manner.
With respect to Claims 4-5, the claims place no limits on what a process parameter may comprise. Holmes teaches wherein the first and second regions may be formed of the same composition/feedstock or different compositions. Where both the first and second region are formed of the same feedstock/composition, the composition parameter may be considered a first and second process parameter applied to both the first and second region fabrication, meeting claims 4 and 5.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 20220184276, drawn to a method of additive manufacturing of a scaffold having controlled porosity.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN A HEVEY whose telephone number is (571)270-0361. The examiner can normally be reached Monday-Friday 9:00-5:30.
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/JOHN A HEVEY/Primary Examiner, Art Unit 1735
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