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 .
Response to Arguments
Applicant's arguments filed May 14, 2026 have been fully considered but they are not persuasive.
It is noted that applicant failed to address the drawing objections.
Applicant has amended the claims, but fails to specify where each of the amendments are supported, described within the originally filed specification. It is hereby requested that the applicant provide for the specific text that describes each and all amendments.
The claims have not been amended to overcome all of the prior 112 rejections. Applicant has insufficiently addressed or not all addressed each of the prior 112 rejections. The claims are directed to new matter. See rejections herein.
It is noted that the prior office action stated claims 5, 9, 13-14, 17, 26, and 30-35 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. However, applicant did not amend any of the above claims according to such statement. Instead, applicant chose to amend claim 1, but claim 1 has not been amended to be version of any of the claims (scope) that was previously indicated as allowable. Claim 1 has been amended to provide for a scope different from that previously considered (as previously stated to applicant during in the phone call referenced by applicant in remarks of supplemental amendment). Therefore, the dependent claims 2-26 and 28-35 are also of a different scope than that previously considered.
As to the prior art rejections, applicant does not provide for any structural arguments directed to any structural distinctions between the language of claim 1 (positively claimed structural elements) and the reference, Breuer (US 2018/0353649), applied under 102 and 103. In regards to the 103 rejection, applicant states:
“The claims have been further amended in view of these comments, and for clarity and to require the limitations that make the device specific for use in seeding a graft that is shaped to a mandrel. Because a potential infringer could sell the cell seeding chamber separate from the cap, the mandrel (which typically would be patient specific and used to shape the graft to be seeded with cells), and suction tube, it is important to have the critical novel feature of the cell seeding chamber (the variable diameter) separate from the cap, mandrel and suction tube positioned within the mandrel (which is essential to pull the cells through a scaffold placed onto the mandrel , although these are required to use the cell seeding chamber.”
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Furthermore, the arguments are not commensurate in scope with claim 1. The claim is directed to an apparatus , a cell seeding chamber that is defined by the positively claimed elements listed in the body of the claim. There is no requirement for the chamber to be used in any method at all including as may intended by applicant for seeding a graft that is shaped to a mandrel. There is no graft, mandrel, suction tube, and scaffold positively claimed as structural elements of the apparatus of claim 1. The clause “for insertion of a suction rod and mandrel into the housing” is directed to intended use of the opening. One is not required to insert anything in the opening of the cap, it is not required that anything all be located in the opening, nor is required the opening to be used for any purpose at all. There is no requirement for any cap comprising an opening because such is only one alternative (not a requirement). However, even if such an alternative is present, there is nothing precluding the opening from being used I any manner as an owner, operator, possessor, etc. of the invention as how one desires, including, but not limited to “venting”, removing and inserting something through the cap.
Furthermore, what a potential infringer could possibly sell and what applicant opines as being “important” are not determining factors for patentability of the claims. However, it is noted that there is no requirement in the claim for any diameter of anything to be separate from any cap; no mandrel; no suction tube located in the mandrel, and no scaffold are positively claimed as structural elements of the chamber of claim 1. Furthermore, there is no requirement for the chamber of claim 1 (defined by the positively claimed elements listed in the body of the claim, not any intended, possible process of use) to be used do anything including to pull any unclaimed, unspecified cells through an unclaimed scaffold on the unclaimed mandrel. As previously stated above, such remarks/arguments are not commensurate in scope with claim 1.
The claims are rejected as given herein. The prior rejections not repeated herein have been withdrawn.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, a housing comprising one or more lateral vent ports and a cap comprising more than one lateral vent port (claim 1); multiple suction rods and caps (provide for in claims 2 and 6 in view of claim 1); the gap between the suction rod or the mandrel and housing (claims 1 and 3); multiple scaffolds and both a graft and scaffold (provided by claim 8 in view of claim 7); seeding chamber comprising a graft or scaffold comprising an inner and an outer surface (as in claim 8 and further claims dependent upon claim 8), fiber peaks (claims 9 and 14), at least two layers and more than two layers (claim 13), and fiber weft pattern (claim 16), fibers having a diameter (of claim 17), polymer coating (claim 18), inner and outer diameter (claim 19), viable autologous cells (claims 23-24), and one or additional agents (claim 25) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. It is noted that each of the recite elements are not represented by reference numerals and/or labeled in the drawings.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus. A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus.
It is noted that although the apparatus claims mention a closed disposable cell seeding system (not structurally defined in the claims), mandrel (claim 1), cells (claim 8), and body fluids (claim 22). However, none of the prior are positively claimed as structural elements. All of such are articles or materials intended to be, can be worked upon, and/or used with the claimed apparatus (a chamber).
It is noted that the phrase “cell seeding” does not further structurally limit the claimed chamber. The phrase is directed to intended, possible use of the chamber.
It is noted that the term “or” recited throughout the claims provides for alternative options. Only one alternative is required to be present.
It is noted that the term “one or more” only requires one. However, the term allows for the presence of any number greater than one.
It is noted that the term “suction” does not provide for any further structure of the rod. The term is directed to intended use. It is noted that the rod is not structurally defined in claim 1 by any structural elements, nor sufficiently structurally claimed relative to any other positively claimed structural elements such that the rod has the structural ability to and/or be used to provide any suction of anything from anything. Claim 1 only provides for an alternative (not a requirement) of a cap (not required to be structurally connected to, the housing nor base) comprising a suction rod.
The term “variable” is presumed to mean more than one width value. It is noted that rather than claiming, requiring the housing to have specific, numerical length and width values, applicant has elected to claim such variable width value(s) relative to percentage values of the length of the housing. However, it is noted that reciting that a greatest width of the variable width values of the housing is located at percentage range such as between about 30% and 60% of the length of the housing does not preclude the same greatest width value from being present (a width value) at other locations (percentage values) along the length of the housing other than (not within) the recited percentage length range. It is noted that any location (including outside of 30% and 60% of the length) of a greatest width of housing relative to a length (not specified, defined as being a total, overall length between any specific, structural definitive points, structural locations along the length, nor definitive structural ends…the claim does not provide any definite structural basis to indicate where/what such length distance is defined by/between) of the housing having a “variable” width can be subjectively considered as being “about” between 30% and 60% of “a” length of the housing because the term “about” is subjective and a housing can be considered as comprising multiple lengths (depending on how one chooses to define such lengths relative to specific structural locations, structural points, structural elements, etc. and relative structural orientation (not specified in the claim) of the housing). Therefore, where the greatest width value is considered as being located percentage wise relative to a length of housing also depends on what/which length of the housing is being referenced to relatively define such greatest width value.
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 1-26 and 28-35 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.
As to claim 1, it is unclear what “its length” references. It is presumed to refer to the length of the housing. If so, the claim should be amended to clearly recite such. Furthermore, it is noted that the claim fails to provide for any structural/nexus connectivity between the housing, cap, and base (not defined as being any specific structure). No cap is required to be attached to (cap) the housing nor base. A list of structures not claimed as, required to be structurally connected does not define a single apparatus (chamber).
Claim 1 recites the limitation "the greatest width" in the last paragraph. There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is noted that there is no relative basis of comparison provided for of such width. It is presumed that “a width” recited in line 3 and “a variable width” are intended to be same, if so the claim should clearly recite such. It is further presumed that “the greatest width” is intended to refer to a greatest width of the variable width of the housing. If so, the claim should clearly recite such.
As to claims 1, it is unclear which/what cap is being referenced by “the cap” because claim 1 previously recites 2 alternatives, a cap comprising an opening and a cap comprising a suction rod. Furthermore, it is noted that the cap alternatives are directed to alternative forms/structures of a cap that are not obvious variants of one another. Such are each distinct species (have mutually exclusive structural characteristics) of a cap.
The term “about” in claim 1, 11-14, 22, and 30-31 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. There is no indication as what degrees of freedom, values other the specific recited values are considered as “about” the specific values because the claim do not provide for such. What may be considered as “about” such specified values to one person may not be considered as such to another and vice versa.
Dependent claims 2-26 and 28-35 are rejected via dependency upon a rejected claim.
As to claim 2, it is unclear what is the structural/nexus of the “a porous mandrel” and “suction rod” recited in claim 2 to each other and “a cap comprising a suction rod” or “a cap comprising an opening” of claim 1 because the claim does not provide for such. As presently drafted, claim 2 provides for the apparatus to comprise a cap comprising a suction rod and further suction rod and a porous mandrel (not required to be connected to a cap nor suction rod as disclosed in the specification and drawings) within the housing. This is not consistent with the specification and the drawings. There is no disclosure of the invention comprising both a cap comprising a suction rod and a (second) suction rod located in the housing. This is new matter.
As to claim 3, it is unclear which/what suction rod is being referenced by “the suction rod” because claim 1 previously “a suction rod” in line 4 and “a cap comprising a suction rod” in line 5 and claim 2 previously recites “suction rod”. All appear to be referring to different suction rods.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation 1 mm and 30 mm, and the claim also recites between 1 and 20 mm, between 1 and 10 mm, or between 1 and 5 mm which is the narrower statement of the range/limitation. This is also applicable to claims 4, 11-15, 17, 19-20, 31, 33, and 35 which recite an initial broad range followed narrower statements directed to the initial broad range. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
As to claim 4, it is unclear what the gap is required to be between, the mandrel and (what?) because the claim does not provide for such.
As to claim 4, it is unclear which/what mandrel is being referenced by “the mandrel” because claim 1 previously “and mandrel” (not positively claimed as structural element of the invention) in line 4 and claim 2 previously recites “a porous mandrel” (not required to be same as the mandrel recited in claim 1). However, it is noted that it has not been clearly established that the chamber comprises any mandrel. Claim 2 provides for a porous mandrel as an alternative option, but it is not required that that any structure of the invention (cap) comprise a porous mandrel nor for a mandrel to be attached to and circumscribe any suction rod. Therefore, it is unclear how such a gap would be present between any mandrel (not positively claimed as element of the invention) and any other prior positively claimed structure.
As to claim 5, it is noted that a “region” is not structurally defined so as to determine the structural boundaries of such region, where such region begins and ends to distinguish such from any other region or structure. Therefore, it is unclear what is structurally required to define “a region”.
As to claim 6, it is unclear what is the nexus of the “a cap having one or more lateral vent ports” to the “a cap comprising an opening (not precluded from being a lateral (vent) opening... port)” and “a cap comprising a suction rod” recited in claim 1 because the claim does not provide for such. It is further unclear what is the structural nexus, connectivity of the “a cap” recited in claim 6 to the other prior positively claimed structural elements housing and base of claim 1 because the claim does not provide for such.
As to claim 7, it is unclear how a scaffold can be required to between “the mandrel” and the housing because no mandrel has been positively claimed as structural element of the invention (not required to be present). Furthermore, it is noted that there is no structural connectivity provided for between the scaffold any other positively claimed element. The term “between” does not require nor provide for any structural connectivity.
As to claim 8, it is unclear what is required of a structure to be considered as an inner surface structure and an outer surface structure of the graft or scaffold because there is no relative basis provided for to determine what is considered inner and outer. Furthermore, it noted that the graft and scaffold are not defined by any other structural elements than such inner and outer surfaces. Furthermore, it is noted that the “allowing…” clause is directed to intended use. No dispersing of any cells to anywhere nor anything is required to ever be performed. It is unclear what is the structural nexus of “or scaffold”, “the…scaffold” recited in claims 8-23, to the prior a scaffold recited in claim 7. It is unclear if such are the same or different because the claim does not provide for such. It is further unclear what is the structural nexus, connectivity of the graft and scaffold to the prior positively claimed structural elements of claim 1 because the claim does not provide for such.
The examiner fails located any description within the originally filed application of the invention comprising more than one scaffold and both a graft and a scaffold as provided for by the scope of claim 8 in view of claim 7. Therefore, claims 8-25 are directed to new matter.
Claim 9 recites the limitation " the polymeric biodegradable vascular graft or scaffold around the mandrel ". There is insufficient antecedent basis for this limitation in the claim. No mandrel has been previously positively claimed as a structural element of the invention and no graft or scaffold has be previously claimed as being located “around” the mandrel. The term “around” does not provide for nor require any structural connectivity to the mandrel and definitive structural location (definitive distance from, between) relative to the mandrel. However, it is unclear how such graft or scaffold can be claimed relative to an unclaimed mandrel that is not an element of the invention.
As to claim 9, it is unclear what is structurally meant, required by the phrase “ arranged axially and polymer fiber peaks arranged circumferentially” because no relative basis has been provided for in the claim. The phrase does not provide for nor require any structural connectivity of any structures to each other. Nothing has been claimed as comprising any axis, no axis has been defined in the claim. Any intangible line can be considered as an axis. Furthermore, nothing has been claimed as comprising any circumference, nor being circular. Furthermore, it is noted that there is no structural nexus provided for between the polymer fiber layers and the polymer fiber peaks.
Claim 13 recites the limitation "the separation between layers". There is insufficient antecedent basis for this limitation in the claim. There is no prior mention of any separation between any layers. It is presumed that “layers” is intended to refer to “the at least two layers” (not required to be any specific layers). If so, the claim should clearly recite such. Furthermore, the examiner fails to locate any description of a graft or scaffold comprising more than two layers as the claim now provides for.
As to claim 14, it is unclear what is what is nexus of “polymer fiber peaks” to that recited in claim 9 because it is unclear if such are the same or different from the “polymer fiber peaks” recited in claim 9 because claim 14 does not provide for such.
As to claim 15, it is unclear what is nexus of “a surface porosity” to the previously recited “an inner surface” and “an outer surface” of claim 8 because the claim does not provide for such.
Claim 15 recites the limitation " the surface area of the biodegradable vascular graft" in the last 2 lines. There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is noted that the claim previously refers to “a graft or scaffold”, but the clause only refers to surface area of the graft. Therefore, it is unclear how the scaffold comprises a surface porosity of the graft.
As to claim 19, it is unclear what is further structurally required by the claim because it has not been previously established that the graft or scaffold is circular and/or comprises any circular element. It is unclear if such is referring to a diameter of fibers (not claimed), some other structural component of the graft or scaffold, or an overall cross-sectional shape of the graft or scaffold because the claim does not provide for such. Furthermore, there is no relative structural basis provided for to indicate what is required of a diameter to be considered as “inner”.
As to claim 22, it is unclear what is further structurally required by the claim because the claim does not provide for any further structural element. The claim is directed to what the graft or scaffold can do following exposure to (unspecified) body fluids. There is no requirement for the graft or scaffold to ever be exposed to any unspecified body fluids for any degrading to occur for any time period. What can or is intended to occur after exposure to body fluids is not structure. This is an intended, possible, process step.
As to claim 23, it is unclear what is the structural nexus, connectivity of “viable autologous cells” to the prior positively claimed structural elements (where such cells are required to be located) because the claim does not provide for such.
The term “conventional immunotherapeutic agents” in claim 25 is a relative term which renders the claim indefinite. The term “conventional immunotherapeutic agents” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. What may be considered as “conventional” immunotherapeutic agents to one person may not be considered as such to another and vice versa. Furthermore, it noted there is no indication as what is required of agent to be considered as “additional” (in addition to what?) because the claim does not provide any relative basis for such. There is no requirement for the any agent(s) to present with (added to) any initial agent(s).
Claim 26 recites the limitation "the environment". There is insufficient antecedent basis for this limitation in the claim. It is unclear what environment (not defined in the claim) is being referenced because the claim does not provide for such. It is further unclear what is structurally meant by “a vessel with fluid”. If applicant intends for the vessel to contain a fluid, then the claim should clearly recite such.
Claim 26 recites the limitation "the mandrel of the seeding chamber" in b). There is insufficient antecedent basis for this limitation in the claim. The seeding chamber nor any positively claimed element of the of claim 1 has not been claimed as comprising a mandrel.
It is unclear what is structurally required, meant by “over” because it is unclear if the phrase refers to a general relative location as in being “above” or if it is intended for the mandrel to surround, circumscribe the rod such that the rod is located within an interior of the mandrel.
It is presumed that the “a graft or scaffold” refers to that recited in the preamble. Therefore, the claim should read as “inserting the graft or scaffold….” However, it is unclear what the graft or scaffold is required to be inserted in because the claim does not specify such…”inserting over the mandrel” does not require the graft or scaffold to be inserted into the seeding chamber.
In c), it is presumed that “the chamber” is “the seeding chamber”. However, the term “the” appears to be missing. The paragraph should read as “…to cover half of the graft of scaffold”.
As to claim 26, it is unclear how the graft or scaffold can be half covered with the fluid because it has not been previously established as being located/inserted in the seeding chamber. The graft or scaffold has not been structurally defined in the claim nor any specific structural description of such relative to the seeding chamber is provided for in the claim.
As to claim 29, it is unclear what is structurally required of a surface of the graft or scaffold to be considered as “inner” and “outer”, respectively because there is no relative structural basis provided in claim to determine inner and outer relative to what.
As to claim 33, it is unclear what is what is required to be done to the graft to be considered as “seeded” because the claim does not provide for any step that requires “seeding” the graft. There is no indication in the claim what is considered as, required to be done to the graft that is considered as “seeding”. Furthermore, claim 26 provides for the alternatives of a graft or a scaffold. Therefore, a graft is not even required to be employed in the method. It is unclear if the time period is directed to a specific step of claim 26 or a time that all of the steps of claim 26 are performed. Therefore, it is unclear how claim 26 further limits the method of claim 26.
As to claim 34, it is unclear how claim 34 further limits the method because the claim does not provide for any additional step nor further limit any prior step of claim 26. It is unclear how and when relative to the steps of claim 26 the graft or scaffold is seeded with cells because there is no prior mention any seeding of the graft or scaffold occurring relative to any of the steps of claim 26. Furthermore, it is unclear what is the nexus of “cells” with the blood or enriched cells of claim 26, if such are the same or different because the claim does not provide for such.
Claim 35 recite the limitations “the cell density” and " the length of the scaffold”. There is insufficient antecedent basis for these limitations in the claim. Furthermore, it is noted that the a scaffold has not been established as being present, employed in the method. Claim 26 previously recites alternatives of a graft or scaffold. Therefore, a scaffold is not ever required to be employed in the method. Furthermore it is unclear what cell density of what is being referenced in the claim because the claim does not provide for such. There is no requirement for any cells to be located on, in, along any surface/structure of the scaffold (“length” is a distance value, not structure). It is noted that the term “inclusive” appears to be unnecessary as it is unclear what the term is intending to modify (what is included in what?).
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 1-26, and 28-35 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.
As to claim 1, the examiner fails to locate any description within the originally filed application of the housing comprising one or more lateral vent ports as now claimed. Furthermore, the examiner fails to locate any description the invention, a chamber comprising a cap comprising more than one lateral vent port as now provided for in claims 1 and 6. Therefore, claims 2-26 and 28-35 are directed to new matter.
The examiner fails to locate any description within the originally filed application of the seeding chamber (nor any positively claimed element as provided for in claim 1) comprising 2 suction rods as provided for by the scope of claim 2 in view of claim 1 as stated above in the 112(b) rejection of claim 2.
The examiner fails locate any description within the originally filed application of the invention, seeding chamber (nor any positively claimed element as provided for in claim 1) comprising more than one scaffold; and both a graft and a scaffold as provided for by the scope of claim 8 in view of claim 7. Therefore, claims 8-25 are directed to new matter.
The examiner fails to locate any description within the originally filed application of a seeding chamber (nor any positively claimed element as provided for in claim 1) comprising a graft or scaffold comprising more than two layers as provided for in claim 13.
As to claim 22, although the claim is directed to a possible, intended process step, the examiner fails to locate any description in the originally filed specification of any method step that describes, requires degrading of the graft of scaffold to occur within six months following exposure to (unspecified) body fluids of anyone nor anything (human, mammal, animal, plant, etc.) as now recited in the amended claim.
As to claim 26, the examiner fails to locate any description of filing the seeding chamber by the alternatives of gravity flow or releasing air from the seeding chamber as now claim. This contradicts the specification (paragraph [0019] of the US Publication) and original claim 26 that provide for, require both of the gravity flow and releasing of air from the seeding chamber to occur to perform the “filling the seeding chamber”. Therefore, claims 26 and 28-35 are directed to new matter.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2 and 5-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alchas et al., US 5,035,708.
Alchas discloses a cell processing device for depositing said cells on the surface of a graft to be implanted in a patient and facilitating implantation of said endothelial graft into a patient (Abstract). The device comprises a housing 54 (Figure 5) that has length and variable width along the length (see difference in with near the lower portion of the chamber near 60, smaller than width above);
a cap (stopper, not labeled in figure 5) having an openings including an opening through which a rod 57 (in a mandrel, not labeled in figure 5) is located and extends into the housing (cap comprising a suction rod);
the cap comprises lateral venting ports 12, 15; and
a base (62)
wherein a greatest width of the housing is positioned between 30% and 60% of the length of the housing. (Figures 5, 7a. 7b).
As to claim 2, suction rod 57 is in the housing 54.
As to claim 25, the scaffold comprise one or more agents, anti-neointima agents, chemotherapeutic agents, steroidal and non-steroidal anti-inflammatories, conventional immunotherapeutic agents, immune-suppressants, cytokines, chemokines, and growth factors. (paragraphs 0008, 31, 87-88).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-8, 10-13, 15-26, 28-30, and 32-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Breuer et al., US 2018/0353649 in view of Alchas et al., US 5,035,708 as applied above.
Breuer discloses a device comprising:
a housing (seeding tube 18, 180) having a width and a length;
a cap (17) having an opening including a rod (20) in the housing and a lateral port (vent 26, 57);
a porous mandrel (scaffold 21) over the rod (20) (paragraphs 0045, 0121-122, 141); and
a base (232 or the unlabeled circular bottom/plate shown in Figures 1B and 1C);
wherein a gap is between a wall of the housing and the rod (20) and mandrel (21) (see figures 1A and 1J).
Breuer does not disclose that the housing has variable width along a length of the housing and a greatest width of the housing is positioned between 30% and 60% of the length of the housing.
The Applicant is advised that the Supreme Court recently clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143).
Common sense, predictability, knowledge, and skill of one of ordinary skill in the art may suffice to establish obviousness.
Alchas (see above) discloses a cell processing device including a housing 54 having variable with along a length of the housing wherein a greatest width of the housing is positioned between 30% and 60% of the length of the housing. (Figures 5, 7a. 7b).
It would have been obvious to and within the common sense, knowledge and skill of one of ordinary skill in the art before the effective filing date of the invention to recognize that housing of Breuer may be manufactured to have a variable with as taught by Alchas as such would yield predictable results. Furthermore, such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art.
As to claims 3 and 19, Breuer does not provide for specific values of the gap, inner diameter of the scaffold, and length of the scaffold as claimed.
It would have been obvious to and withing the common sense, knowledge and skill of one of ordinary skill in the art before the effective filing date of the invention to recognize that the gap, inner diameter, and length of the scaffold may be manufactured to any desirable values including the values provided for in the in claims as such would yield predicable results. Furthermore, such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art.
As to claim 4, the housing has variable (different) width at over the length of the housing. See at the top the threads and bottom (base) (Figures 1B and 1C).
As to claims 10-12 and 15, the pores of the device are between 5 and 500 μm (paragraph 0045).
As to claims 13, 15-16, 18, and 21-22, scaffolds can be synthesized from one or more polymers and layers. (paragraphs 0075, 77-80).
As to claim 17, Breuer discloses the fibers comprising the scaffold matrix can be of any desired size, but generally are between about 1.5 mm and 1 nm. In certain embodiments, the fibers are nanoscale (i.e., from about 1 nm to about 1000 nm) and/or microscale (from about 1 μm to about 1000 μm). (paragraph 0078).
As to claims 23-24, the scaffold comprise autologous/bone marrow cells. (paragraphs 0005, 56, 58, 83).
As to the method claims 26, 28-29, and 34, Breuer discloses:
Referring to FIG. 1A, (i) a bone marrow aspirate (e.g., 5 cc/kg body weight) is aseptically collected and injected into cell isolate fluid container (3); (ii) using a vacuum, the bone marrow aspirate is passed through a flow channel (7) including a filter which traps the bone marrow derived-mononuclear cells as the aspirate passes from the upstream surface of the filter medium and through the downstream surface of the filter medium; (iii) the remaining portion of the bone marrow aspirate (which is typically composed primarily of plasma, but may include red blood cells and/or platelets) is collected in collection fluid container (13); (iv) the elution solution in elution fluid container (9) is passed through the flow channel (7), wherein the elution solution passes from the downstream surface of the filter medium and through the upstream surface of the medium, and into a seeding container (18) such that the filter releases the bone marrow-derived mononuclear cells which are collected in the seeding container; (v) the seeding container (18) contains a scaffold that is inserted over a perforated mandril (20); (vi) the bone marrow-derived mononuclear cell suspension fills the seeding container (18) completely covering the scaffold that is inserted over the perforated mandril (20); (vii) a vacuum (e.g., −20 mm Hg) is applied until all of the cell suspension has passed through the scaffold and is collected in at least one residual seeded cell fluid container (35a, 35b); and (viii) the filtered bone marrow aspirate, typically primarily comprising plasma, is passed, using flow induced by a vacuum, from the collection container (13), into seeding container (18), which contains the seeded scaffold, thus bathing the seeded scaffold. (paragraph 0141).
As to claim 30, typical volumes of cell solutions range between 1 ml and 100 ml, inclusive, preferably between 10 ml and 50 ml. (paragraph 0055).
As to claim 32, the length of the scaffold can be within the recited range of 10 cm to 15 cm. (paragraphs 0119, 131, 169).
As to claim 33, the seeding can occur within the recited time range. (paragraphs 0014, 0071, 0135, 0199, 0207)
As to claim 34-35, the graft or scaffold can be seeded with a density within the recited ranges. (paragraph 0016, 62, 64, 66, 210).
Conclusion
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 BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
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/BRIAN R GORDON/Primary Examiner, Art Unit 1798
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