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 and 16-20, in the reply filed on 6/26/26 is acknowledged.
Claims 6-12 and 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/26/26.
Claim Status
Claims 13 and 14 are cancelled.
Claims 1-12 and 15-20 are pending.
Claims 6-12 and 15 are withdrawn.
Claims 1-5 and 16-20 are presented for examination on the merits.
Priority
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Acknowledgment is made of applicant's claim for foreign priority based on an application filed in GERMANY 10 2022 000 698.7 filed on 02/26/2022. It is noted, however, that applicant has not filed a certified copy of the foreign application as required by 37 CFR 1.55. Applicant requested for the USPTO to retrieve said foreign priority document. However, attempts by the Examiner to retrieve it were not successful at this time. As per MPEP 215.02(a): “Applicants continue to bear the ultimate responsibility for ensuring that the priority document is filed during the pendency of the application and before the patent is issued.”
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 8/21/24 and 6/26/26 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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) 1-5, 16 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wen et al. (Progress in Natural Science: Materials International 31 (2021) 324–333; of record).
Regarding claims 1-3, 16 and 18, Wen et al. disclose medical biodegradable magnesium alloy and hydroxyapatite coatings where the impedance value reached 1.0 X 105 Ω▪cm2, hence greater than one or more of: Zim > 10,000Q or Zre > 50,000 Q and within the ranges of claim 17and the early corrosion of magnesium alloy substrate was effectively delayed (Title; Abstract: Page 324, Introduction; Figure 7) as measured by the electrochemical impedance spectroscopy test (Page 327, left column last paragraph). Because the hydroxyapatite is naturally white, and white has the maximum lightness value, then the coating inherently has a brightness in the L*a*b* color space of more than 95 and is in a range of 97-100.
Regarding claim 4, the 10 mm by 10 mm by 2 mm square specimens (Page 326, 2. Test Material and methods) coated with hydroxyapatite by Wen et al. could be used as bone plates.
Regarding claims 5, 19 and 20, Wen et al. disclose that AZ31B magnesium alloy contains (Page 325, Table 1):
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Thus, it contains zinc and manganese and magnesium is present at least 95% by weight. The other claimed properties of the coating, such as wherein the coating has an initial melting point above 1000 °C; and wherein the coating has a medium lattice bond energy of less than -2000 kJ/mol, wherein the coating has an in-between medium lattice bond energy surface to a top surface; wherein the initial melting point is between 2000° and 3000° Celsius and wherein the lattice bond energy is between 1000 and 4000 kJ/mol, appear to be inherent characteristics of the hydroxyapatite coating. Once a prima facie case of anticipation has been established, the burden shifts to the Appellants to prove that the prior art product does not necessarily or inherently possess the characteristics of the claimed product. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (“Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product.”). Also note MPEP 2112(I): “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). Also note that: "[A] prior art reference may anticipate when the claim limitation or limitations not expressly found in the reference are nonetheless inherent in it." MEHL/Biophile Int'l Corp. v. Milgraum, 192 F.3d 1362, 1364 (Fed.Cir.1999). "Under the principles of inherency, if the prior art necessarily functions in accordance with, or includes, the claims limitations, it anticipates." Id.; see also In re King, 801 F.2d 1324,1326-28 (Fed.Cir.1986). Since Wen et al. disclose the same biodegradable magnesium alloy implant with the same hydroxyapatite coating, then the properties claimed are also found in the implant of Wen et al.
Claim(s) 1-5 and 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eliezer et al. (US20200123636).
Regarding claims 1-3, 5 and 16, Eliezer et al. disclose:
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The hydroxyapatite coating is inherently white with a color space of more than 95 or 97-100. Regarding claims 1, 5, 17, 19 and 20, since Eliezer et al. disclose the same materials, then the same impedance is inherent in the implant. Where the claimed and prior art products are identical or substantially identical the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on "prima facie obviousness" under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO' s inability to manufacture products or to obtain and compare prior art products. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). See MPEP 2112(V).
Regarding claim 4, Eliezer et al. disclose a specific example as a bone plate [0086].
Also note that: "[A] prior art reference may anticipate when the claim limitation or limitations not expressly found in the reference are nonetheless inherent in it." MEHL/Biophile Int'l Corp. v. Milgraum, 192 F.3d 1362, 1364 (Fed.Cir.1999). "Under the principles of inherency, if the prior art necessarily functions in accordance with, or includes, the claims limitations, it anticipates." Id.; see also In re King, 801 F.2d 1324,1326-28 (Fed.Cir.1986). Since Eliezer et al. disclose the same biodegradable magnesium alloy implant with the same hydroxyapatite coating, then the properties claimed are also found in the implant of Eliezer et al.
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 1-5 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Dingeldein et al. (US10010652) and Eliezer et al. (WO2019002277).
Applicant claims, for example:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “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 medical implant research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medical implant materials and formulation techniques— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 1-3 and 16, Dingeldein et al. teach an implant comprising biodegradable magnesium based alloy (Claim 1) with a hydroxylapatite coating (Claims 2-3) of 1 to 100 micron thickness (Claim 8) as shown in coated screw of Figure 2a (Column 10, lines 60-63) and showing degradation resistance (Column 14, lines 21-30; column 15, lines 40-41).
Regarding claim 4, Dingeldein et al. teach the implant in the form of plates, screws, nails and anchors (Column 9, line 65 though column 10, line 3; claim 14; Figure 2).
Regarding claim 5, Dingeldein et al. teach a magnesium alloy with 96% magnesium (Column 10, lines 19-21) and is at least 90 wt% magnesium (Column 10, lines 12-18).
Regarding claims 1 and 5, Eliezer et al. teach a magnesium alloy which comprises: Zn: 0.5 - 2 wt%, Mn: 0.2 - I wt%, Ca: 0.1 - 2 wt%, (Abstract) and is coated with a continuous layer of at least 5% or at least 30% hydroxyapatite (Page 7, lines 5-10; Figure 13; claims 1-5) with a thickness of 1-100 microns (Page 7, lines 14-15).
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 Dingeldein et al. is that Dingeldein et al. do not expressly teach the electrochemical impedance of claims 1 and 17 or wherein the coating has an initial melting point above 1000 °C; and wherein the coating has a medium lattice bond energy of less than -2000 kJ/mol, wherein the coating has an in-between medium lattice bond energy surface to a top surface; wherein the initial melting point is between 2000° and 3000° Celsius and wherein the lattice bond energy is between 1000 and 4000 kJ/mol. However, these characteristics appear to be implicit in the hydroxyapatite coating taught by Dingeldein et al. and optimized by adjusting the coating thickness1 and/or particle size of the apatite powder. See MPEP 2112.01(I) Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
The difference between the instant application and Dingeldein et al. is that Dingeldein et al. do not expressly teach that the magnesium alloy comprises one or more of: calcium, zinc or manganese. This deficiency in Dingeldein et al. is cured by the teachings of Eliezer et al.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the calcium, zinc and manganese containing magnesium alloy of Eliezer et al. for the magnesium alloy taught by Dingeldein et al., and produce the instant invention. One of ordinary skill in the art would have been motivated to do this because Dingeldein et al. is open to other magnesium alloys and Eliezer et al. teach a magnesium alloy with calcium, zinc and manganese that can be coated with hydroxyapatite and thus a functional equivalent. “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, the ordinary artisan would have a reasonable expectation of success in so doing.
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.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-5 and 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8-9 and 14 of U.S. Patent No. US10010652 in view of Eliezer et al. (WO2019002277). Although the claims at issue are not identical, they are not patentably distinct from each other because regarding claims 1-3 and 16, the patent teaches an implant comprising biodegradable magnesium based alloy (Claim 1) with a hydroxylapatite coating (Claims 2-3) with controlled degradation (Claim 5) of 1 to 100 micron thickness (Claims 8-9).
Regarding claim 4, the patent teaches the implant in the form of plates, (Claim 14).
Regarding claim 5, the patent does not expressly teach a magnesium alloy with 96% magnesium but the patent teaches that the scope of magnesium alloy includes 96% magnesium (Column 10, lines 19-21) and is at least 90 wt% magnesium (Column 10, lines 12-18). MPEP 804: “The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim.”
The patent does not expressly teach Zn, Mn or Ca. However, Eliezer et al. teach a magnesium alloy which comprises: Zn: 0.5 - 2 wt%, Mn: 0.2 - I wt%, Ca: 0.1 - 2 wt%, (Abstract) and is coated with a continuous layer of at least 5% or at least 30% hydroxyapatite (Page 7, lines 5-10; Figure 13; claims 1-5) with a thickness of 1-100 microns (Page 7, lines 14-15). Consequently it would be obvious to employ the alloy of Eliezer et al. in the patent with a reasonable expectation of success.
The patent does not expressly teach the impedance claimed, brightness L* claimed, initial melting point range claimed or lattice bond energy range claimed or in-between medium lattice bond energy claimed. However, these characteristics appear to be implicit properties of the hydroxyapatite coating and/or optimized by adjusting the coating thickness. See In re Best above.
Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patented subject matter in view of Eliezer et al.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bhaduri et al. (WO2015171585) teach biodegradable magnesium alloy implant with a hydroxyapatite coating (Claims 1-9, 11 and 12), in the form of plates and screws (Claim 13) where the degradation rate is controlled by adjusting the thickness of the coating (Claim 31). Dunne et al. (Surface & Coatings Technology 2016;289:37-44) report on the corrosion behavior of biodegradable magnesium alloys with hydroxyapatite coating (Title; Abstract; Figure 12). Please note that the examiner is not called upon to cite all references that may be available, but only the "best." (See 37 CFR 1.104(c).) Multiplying references, any one of which is as good as, but no better than, the others, adds to the burden and cost of prosecution and should therefore be avoided. See MPEP 904.03.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Y Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613
1 The artisan would expect the impedance to increase as the coating thickness increases because the coating serves as an insulator and a thicker layer would add more resistance to block the flow of electrical current. A thicker coating also has lower capacitance and higher impedance because the impedance is inversely proportional to the capacitance. See Page 89 left column Ccoating: Coating Capacitance in: Loveday et al. ([online] retrieved on 8/1/26 from: https:// docs.paint.org/Ct-Analytical-Series/Gamry2_October2004-1696.pdf; 2004:88-93).
Prosecution Insights