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 .
Specification
The substitute specification filed 16 February 2024 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(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 1-4 and 6-11 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
As assessed by the Wands Factors and the evidence as a whole, the claims are not enabled. See MPEP 2164.01(a).
Wands Factors include (A)-(H): (A) The breadth of the claims: The claims encompass films achieving specified antibacterial activity which films are to comprise Mg and optionally Ca, as specified, and there is no limit to presence or absence of other ingredients in terms of identity and relative amounts; (B) The nature of the invention: The invention relates to biocompatible films formed of Mg and optionally Ca that achieve specified degree of antibacterial activity; (C) The state of the prior art: The reviewed prior art, as reflected below in the prior art rejections, demonstrates films that consist of Mg and optionally Ca, as specified, which would be expected to inherently achieve the claimed level of antibacterial activity; however, the reviewed prior art does not demonstrate express teaching or suggestion of claimed level of antibacterial activity for these films or for films that consist essentially of or comprise Mg and optionally Ca, as specified; (D) The level of one of ordinary skill: One of ordinary skill in the art would be expected to be able to form sputtered films that consist of Mg and optionally Ca, as specified, and to be able to make sputtered alloy films or to make films comprising Mg and optionally Ca, as specified, by other techniques; however, such one of ordinary skill in the art would have no tools to render such film of claimed antibacterial activity; (E) The level of predictability in the art: The art is predictable in terms of being able to form films by sputtering or otherwise, but there is no basis for assessing what would be predictable in terms of achieving claimed antibacterial activity since there is no guiding principle that is known that could be followed for films that do not consist of Mg and optionally Ca, as specified; (F) The amount of direction provided by the inventor: The Specification teaches basic method of sputtering for alloys that consist of Mg and optionally Ca, as specified; the Specification explains that such films can lead to specified claimed level of antibacterial activity; the Specification fails to offer general principle or guidance that would govern how to extend beyond such films that consist of Mg and optionally Ca, as specified, that are formed by sputtering that would lead to specified level of antibacterial activity; the Specification offers a mechanism that is based on dissolution of sputtered films of Mg and optionally Ca as leading to claimed level of antibacterial activity; (G) The existence of working examples: The Specification reports results of films that are sputtered that consist of Mg and optionally Ca, as specified, that achieve claimed level of antibacterial activity; AND (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure: The quantity of experimentation would be unreasonably broad because there is no basis for expecting films that have additional ingredients in terms of identity and relative amounts to be able achieve claimed level of antibacterial activity based on the record; such additional ingredients could unpredictably inhibit, interfere with, or otherwise overwhelm dissolution of Mg and optionally Ca, which is the mechanism the Specification attributes to effectiveness of these films.
The following is a quotation of 35 U.S.C. 112(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 1-4 and 6-11 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.
Regarding Claim 1, it is unclear what test is being claimed for the antibacterial activity. Is it that of the Specification, necessarily, at, for example, paragraph 23? If not, what is it?
Regarding Claims 2 and 3, it is unclear what medium of incubation is being claimed.
Regarding Claim 7, it is unclear what it the relationship between the film and substrate. Are they laminated on one another?
Regarding Claim 9, it is unclear whether the claimed surface roughness is to be exposed or to be at the interface of the film and substrate. It is unclear whether Ra is to be measured as set forth in the Specification, or, if not, what method is to be used since the method can affect value obtained.
Regarding Claim 10, it is unclear whether “a rectangular parallelepiped and a cube” is a single shape or alternatives.
Claim Rejections - 35 USC § 102/103
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.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-4 and 7-11 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over ZAATREH, Sarah et al., Fast corroding, thin magnesium coating displays antibacterial effects and low cytotoxicity, Biofouling, 2017, vol. 33(4), pp. 294-305 (p. 294, "Abstract", p. 302, left column, lines 1-4, page 303, "Conclusion", tables 1, 2, fig. 1-6, p. 298, left column, line 1 to right column, line 5). Zaatreh discloses an antibacterial implant for reducing implant-related infections, and indicates that, inter alia: a sample in which a cylindrical titanium alloy [Ti6Al4V] base [page 295, right side] (having a surface roughness Ra of about 0.31 µm) [page 298, bottom, left side] is coated by a magnesium thin film (corresponding to the "biocompatible film" of claim 1 of the present application) [Figure 2(c)] which was manufactured by sputtering [page 295, right side]; the magnesium-coated sample was dissolved in a cell culture medium and made to release magnesium, and this release kept the pH of the culture medium alkaline and suppressed the growth of Staphylococcus epidermidis (p. 294, "Abstract", tables 1-2, fig. 1-6, p. 298, left column, line 1 to right column, line 5).
Zaatreh also indicates that magnesium is known to have an antibacterial effect against Staphylococcus aureus, that it is important to consider parameters such as amorphousness in order to regulate the solubility (corrosivity) of magnesium, and that the sample is useful as artificial bone (p. 302, left column, lines 1-4, p. 303, "Conclusion").
Since the coating only contains Mg, it is free of Mg2Ca.
Zaatreh does not explicitly indicate that the magnesium-coated sample has the property in claim 1 of "having such antibacterial properties that the antibacterial activity value is 2.0 or above", the property in claims 2 and 3 of "having such antibacterial properties that when inoculation is performed with 0.16 µl/mm2 of a test bacterial solution in which the viable Staphylococcus aureus bacteria count is 2.5 x 105 to 10 x 105 cells/ml, the average number of viable bacteria after 24 hours is 75% or below of that at the time of inoculation", or the property in claim 4 in which "the biocompatible film has such dissolution properties that the biocompatible film dissolves in a Hanks balanced solution”.
However, Zaatreh discloses using sputtering to manufacture a metal film in which a titanium alloy serving as a biocompatible base is covered by magnesium. The film in Zaatreh is crystalline, which applicant’s film is, and both are formed by sputtering with no intentional heating. See Specification (Figure 1: Mg(hcp)). Thus, it would be expected that the film in Zaatreh and applicant’s film are the same or substantially the same in terms of composition and structure and so they would be expected to have the same properties being claimed.
Claim Rejections - 35 USC § 103
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over ZAATREH, Sarah et al., Fast corroding, thin magnesium coating displays antibacterial effects and low cytotoxicity, Biofouling, 2017, vol. 33(4), pp. 294-305 (p. 294, "Abstract", p. 302, left column, lines 1-4, page 303, "Conclusion", tables 1, 2, fig. 1-6, p. 298, left column, line 1 to right column, line 5). Zaatreh is relied upon as set forth above in the section 102/103 rejection over Zaatreh. Zaatreh may not exemplify an artificial bone material, but teaches that Zaatreh’s materials are suitable for these applications (page 294, first sentence; page 303, Conclusion section). It would have been obvious to one of ordinary skill in the art before the time of filing to prepare composites of Zaatreh as artificial bone material since Zaatreh teaches they would be expected to be useful in these types of applications.
Claim(s) 1-4 and 6-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over ZAATREH, Sarah et al., Fast corroding, thin magnesium coating displays antibacterial effects and low cytotoxicity, Biofouling, 2017, vol. 33(4), pp. 294-305 (p. 294, "Abstract", p. 302, left column, lines 1-4, page 303, "Conclusion", tables 1, 2, fig. 1-6, p. 298, left column, line 1 to right column, line 5) in view of Yang USPA 2010/0075162. Zaatreh discloses an antibacterial implant for reducing implant-related infections, and indicates that, inter alia: a sample in which a cylindrical titanium alloy [Ti6Al4V] base [page 295, right side] (having a surface roughness Ra of about 0.31 µm) [page 298, bottom, left side] is coated by a magnesium thin film (corresponding to the "biocompatible film" of claim 1 of the present application) [Figure 2(c)] which was manufactured by sputtering [page 295, right side]; the magnesium-coated sample was dissolved in a cell culture medium and made to release magnesium, and this release kept the pH of the culture medium alkaline and suppressed the growth of Staphylococcus epidermidis (p. 294, "Abstract", tables 1-2, fig. 1-6, p. 298, left column, line 1 to right column, line 5).
Zaatreh also indicates that magnesium is known to have an antibacterial effect against Staphylococcus aureus, that it is important to consider parameters such as amorphousness in order to regulate the solubility (corrosivity) of magnesium, and that the sample is useful as artificial bone (p. 302, left column, lines 1-4, p. 303, "Conclusion").
Zaatreh teaches that magnesium alloys with Ca may also be used (page 295, left side), including Mg45Zn5Ca.
Yang discloses manufacturing an implant for orthopedic or dental use, in which a magnesium-based alloy coating, including pure Mg, (corresponding to the "biocompatible film" of claim 1 of the present application) is applied by sputtering onto a titanium alloy base material for biological use, and also indicates that the magnesium-based alloy can be one in which 0-33 wt% of calcium is added to magnesium (embodiments 1, 2, and 5). Yang also indicates that: the magnesium-based alloy corrodes in a corrosive liquid comprising substances similar to those in human body fluids, i.e., the magnesium-based alloy dissolves; and an increase in the calcium content of the magnesium-based alloy increases the corrosion speed (embodiment 4). Yang also indicates that when the magnesium-based alloy was grafted into the living body, bone tissue was formed in a satisfactory manner after the magnesium-based alloy was degraded (paragraph [0047]).
It would have been obvious to one of ordinary skill in the art before the time of filing to provide a Mg33wt.%Ca coating of Yang as the coating of Zaatreh since both teach that these coatings are antibacterial in orthopaedic applications and both teach that Mg/Ca coatings are among those expected to be effective.
Neither Zaatreh nor Yang explicitly indicates that the magnesium-coated sample has the property in claim 1 of "having such antibacterial properties that the antibacterial activity value is 2.0 or above", the property in claims 2 and 3 of "having such antibacterial properties that when inoculation is performed with 0.16 µl/mm2 of a test bacterial solution in which the viable Staphylococcus aureus bacteria count is 2.5 x 105 to 10 x 105 cells/ml, the average number of viable bacteria after 24 hours is 75% or below of that at the time of inoculation", or the property in claim 4 in which "the biocompatible film has such dissolution properties that the biocompatible film dissolves in a Hanks balanced solution”.
However, Zaatreh discloses using sputtering to manufacture a metal film in which a titanium alloy serving as a biocompatible base is covered by magnesium. Both Zaatreh’s and applicant’s films are formed by sputtering with no intentional heating. Thus, it would be expected that the film in Zaatreh in view of Yang and applicant’s film are the same or substantially the same in terms of composition and structure and so they would be expected to have the same properties being claimed.
While the demonstrated films in Zaatreh are crystalline, Zaatreh teaches that amorphous films can be used as well (page 303, right side, first full paragraph). Applicant teaches that Mg33wt.%Ca is amorphous and having no Mg2Ca. See Specification (Figure 1: Mg30%Ca; and paragraph 19)). Thus the absence feature of Mg2Ca of Claims 1 and 3 is expected to be inherently achieved. As well, the amorphous structure feature of Claim 6 is expected to be inherently achieved.
Regarding Claim 11, Zaatreh may not exemplify an artificial bone material, but teaches that these composite materials are suitable for these applications (page 294, first sentence; page 303, Conclusion section). It would have been obvious to one of ordinary skill in the art before the time of filing to prepare composites of Zaatreh in view of Yang as artificial bone material since Zaatreh suggests they would be expected to be useful in these types of applications.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL E. LA VILLA whose telephone number is (571)272-1539. The examiner can normally be reached Mon. through Fri. from 9:00 a.m. ET to 5:30 p.m. ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Humera N. Sheikh, can be reached at (571) 272-0604. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL E. LA VILLA/Primary Examiner, Art Unit 1784
7 February 2026