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 .
Priority
The pending application filed December 3, 2024 is a Continuation of 18/434,132 filed February 6, 2024, which is a Continuation-in-Part of 18/228,456 filed July 31, 2023, which claims priority to US Provisional 63/422,619 filed November 4, 2022.
Response to Restriction Election
Applicant’s election of Species III, a rhenium and titanium alloy with aluminum, in the reply filed on December 17, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The November 5, 2025 Restriction Requirement states on p. 7 para. 3 that “Applicant is advised that the reply to this requirement to be complete must include…(ii) identification of the claims encompassing the elected species…”. In the December 17, 2025 reply applicant did not particularly point out the claims that read on the elected species.
Independent claim 35 lines 14-22 recite the following properties:
said expandable body has a recoil of less than 5% after being subjected to a first crimping process;
said expandable body has a recoil of less than 5% after being expanded from said crimped state to said expanded state;
said metal alloy has a hydrophilicity wherein a contact angle of a water droplet on a surface of said metal alloy is 25-45°;
said metal alloy has a maximum ion release of a primary component of said metal alloy when inserted or implanted on or in the body of the patient of no more than 0.5 ug/cm2 per day, wherein said primary component constitutes at least 2 wt.% of said metal alloy; and/or
e) said metal alloy has an absolute increase in ion release per dose of metal alloy in tissue about said medical device of no more than 50 days after inserted or implanted on or in the body of a patient.
Independent claim 42 lines 11-17 recite one or more properties selected from the group consisting of
a) said metal alloy has a hydrophilicity wherein a contact angle of a water droplet on a surface of said metal alloy is 25-45°,
b) said metal alloy has a maximum ion release of a primary component of said metal alloy when inserted or implanted on or in the body of the patient of no more than 0.5 ug/cm2 per day, wherein said primary component constitutes at least 2 wt.% of said metal alloy, and
c) said metal alloy has an absolute increase in ion release per dose of metal alloy in tissue about said medical device of no more than 50 days after inserted or implanted on or in the body of a patient.
Applicant’s specification discloses these properties of claims 35 and 42 in [00135]-[00141] as requiring “a medical device that includes a metal alloy…the metal alloy comprises rhenium, molybdenum, and optionally one or more alloying elements” or, for “recoil of less than 5%”, “a medical device that includes a metal alloy…wherein the metal alloy comprises rhenium, molybdenum, chromium, and optionally one or more alloying metals”.
Species III, the metal alloy elected for examination, requires rhenium, titanium, and aluminum. It does not include molybdenum. Therefore, claims 35, 38-43, and 46-51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected metal alloy species, there being no allowable generic or linking claim due to being directed to a nonelected species because the claimed properties are directed to a non-elected metal alloy composition requiring rhenium and molybdenum.
The November 5, 2025 Restriction Election included metal alloy species on pp. 2-5, mechanical property species on p. 5, region species on p. 5, metal alloy property species on p. 6, and recoil species on p. 6. Applicant’s December 17, 2025 reply only elected a metal alloy species.
The mechanical property species on p. 5 are directed to a relative increase in ductility or tensile strength. Applicant’s specification, such as [0009] and [0013], discloses the relative increase of at least 10% of ductility and/or tensile strength as a “rhenium effect” from providing a metal alloy that includes rhenium. Elected metal alloy Species III includes at least 15 awt.% Re, such that both mechanical property species appear to be properties of the elected metal alloy species and the mechanical property species restriction requirement is withdrawn in light of applicant’s elected metal alloy species.
The region species on p. 5 are directed to a biological agent or polymer. Applicant’s specification, such as [0090]-[0092], disclose a biological agent and/or polymer coated on the medical device including both a biological agent a polymer. Therefore, it is within the scope of applicant’s invention to include both the biological agent and polymer, such that the region species restriction requirement is withdrawn in light of applicant’s elected metal alloy species.
The metal alloy property species on p. 6 are directed to hydrophilicity, max ion release, and increase ion release. As discussed previously, according to [00139]-[00141] of applicant’s specification, these properties require a metal alloy comprising rhenium, molybdenum, and optionally one or more alloying elements. This composition is outside the scope of the metal alloy Species III with rhenium, titanium, and aluminum elected for prosecution. Therefore, all of the metal alloy property species are withdrawn from consideration in light of applicant’s elected metal alloy species.
The recoil species on p. 6 are directed to crimping and expanding. As discussed previously, according to [00135]-[00138] of applicant’s specification these properties require a metal alloy comprising rhenium, molybdenum, and optionally one or more alloying elements or comprising rhenium, molybdenum, chromium, and optionally one or more alloying elements. These compositions are outside the scope of the metal alloy Species III with rhenium, titanium, and aluminum elected for prosecution. Therefore, all of the recoil species are withdrawn from consideration in light of applicant’s elected metal alloy species.
Title Amendment
Applicant’s title amendment, “Metal Alloy Having Rhenium Effect” filed December 17, 2025 is acknowledged.
Information Disclosure Statement
No information disclosure statement (IDS) was filed. In nonprovisional applications, applicants and other individuals substantively involved with the preparation and/or prosecution of the application have a duty to submit to the Office information which is material to patentability as defined in 37 CFR 1.56. MPEP 609. Each individual associated with the filing and prosecution of a patent application has a duty to disclose to the Office all information known to that individual to be material to patentability. These duties, of candor and good faith and disclosure have been codified in 37 CFR 1.56 and 37 CFR 1.555. MPEP 2000.01.
Claim Status
This Office Action is in response to Applicant’s Restriction Election and Claim Amendments filed December 17, 2025.
Claims Filing Date
December 17, 2025
Pending
26, 29-35, 38-43, 46-51
Cancelled
1-25, 27, 28, 36, 37, 44, 45
Withdrawn
35, 38-43, 46-51
Under Examination
26, 29-34
Drawings Objections
The drawings are objected to because
Figs. 1-3 do not appear to include all of the alleged information. Applicant’s specification at [00159] recites that “FIGS. 1-3 provide a comparison of the tensile strength, the yield strength and the ductility of a titanium alloy, a cobalt-chromium alloy and a molybdenum-rhenium alloy”. However, Fig. 1, “Titanium Alloy” only includes one line, which appears to be yield strength, such that it is lacking tensile strength and ductility. Fig. 2, “CoCr Alloy” also only includes one line, which appears to be yield strength, such that it is lacking tensile strength and ductility. Fig. 3, “MoRe Alloy” includes no lines, such that it is lacking tensile strength, yield strength, and ductility information. Further, Figs. 1 and 2 do not include a scale on the x-axis regarding the “Increasing Cold-Work Processing”, such that it is unknown what values the data is being presented for.
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.
Specification Objections
The disclosure is objected to because of the following informalities:
[0021]-[0032] line 2 “the medical device is partially for fully formed” is grammatically incorrect.
[0038] lines 2-3, 7, and 11 and [0067] lines 28 and 30 “weigh percent” appears to be a typographical error.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 26 and 29-34 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.
In order to determination compliance with the enablement requirement of 35 U.S.C. 112(a), the following Wands factors can be used to assess whether any necessary experimentation required by the specification is “reasonable” or “undue”. These factor include, but are not limited to:
The breadth of the claims;
The nature of the invention;
The state of the prior art;
The level of one of ordinary skill;
The level of predictability in the art;
The amount of direction provided by the inventor;
The existence of working examples; and
The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Claim 26 lines 17-18 “III) at least 15 awt.% rhenium and 70-91.5 wt.% titanium, and…a) 2-8 wt.% aluminum” fails to comply with the enablement requirement.
The metal alloy species composition elected by applicant for examination requires 70-91.5 wt% Ti, 2-8 wt% Al, and at least 15 awt.% Re. However, for the given amounts of Ti and Al, the remaining content as Re is less than 15 awt.% Re. Alternatively, for the given Re content, the Ti and/or Al content is outside of the claimed range. As evidence, in the following table Re-Ti-Al wt% compositions were converted to at% by dividing wt% by atomic weight, summing the resulting values, then dividing each individual value by the sum, as known by one of ordinary skill in the art.
Composition (wt%)
Composition (at%)
70 Ti- 2 Al- 28 Re
86.7 Ti- 4.4 Al- 8.9 Re
70 Ti- 8 Al- 22 Re
77.9 Ti- 15.8 Al- 6.3 Re
91.5 Ti- 2 Al- 6.5 Re
94.6 Ti- 3.7 Al- 1.7 Re
91.5 Ti- 8 Al- 0.5 Re
86.5 Ti- 13.4 Al- 0.1 Re
56.6 Ti- 2 Al- 41.4 Re
80.0 Ti- 5.0 Al- 15.0 Re
48.75 Ti- 8 Al- 43.25 Re
65.8 Ti- 19.2 Al- 15.0 Re
For 70 wt% Ti and 2-8 wt% Al, the Re awt.% ranges from 6.3 to 8.9. For 91.5 wt% Ti and 2-8 wt% Al, the Re awt.% ranges from 0.1 to 1.7. Both Re contents are less than the required “at least 15 awt.% rhenium”. Alternatively, 15.0 awt.% Re is achieved with 56.6 wt% Ti and 2 wt% Al or 48.75 wt% Ti and 8 wt% Al. Both Ti contents are outside of the required range of 70 to 91.5 wt%.
Therefore, the breadth of the claims recites a composition of Ti, Al, and Re that cannot be achieved. When the Ti content is within the claimed range, the Re content is outside of the claimed range. Alternatively, when the Re content is within the claimed range, the Ti content is outside of the claimed range.
The inventor provides direction of a “Titanium Alloy” in Fig. 1. Applicant’s specification at [0166] states “The titanium alloy is a Ti-6Al-4V alloy.” This example does not include at least 15 awt.% Re.
Applicant’s specification from pp. 14-48 includes a table of compositions. Exs. 11, 12, 165, 166, 174, 177, 178, and 186 broadly overlap with the metal species alloy composition elected for examination. Similarly, applicant’s specification at [0150] discloses the composition of metal alloy species III). However, as discussed previously, when satisfying the claimed Ti content the Re content is outside of the claimed awt.% of at least 15 and, alternatively, when satisfying the claimed Re content the Ti content is outside the claimed wt% of 70-91.5.
Applicant’s specification includes no working examples.
Further, in the prior art, such as US 3,880,655, when 70-91.5 wt% Ti is present is an alloy, the Re content is less than 15 awt.%. Alternatively when at least 15 awt.% Re is present, such as US 5,693,156, the Ti content is less than 70 wt%.
Therefore, for the above cited reasons, elected metal alloy species III) with 70-91.5 wt% Ti, 2-8 wt% Al, and 15 awt.% Re lacks enablement.
Claim 29 line 2 “less than 25 wt.% rhenium” fails to comply with the enablement requirement.
The metal alloy species composition under examination also requires 70-91.5 wt% Ti and 2-8 wt% Al. A 70-91.5 wt% Ti and 2-8 wt% Al alloy with less than 25wt% Re does not also satisfy at least 15 awt.% Re as required by claim 25. As evidence by the following table, Re-Ti-Al wt% compositions were converted to at% by dividing wt% by atomic weight, summing the resulting values, then dividing each individual value by the sum, as known by one of ordinary skill in the art.
Composition (wt%)
Composition (at%)
70 Ti- 5 Al- 25 Re
82.1 Ti- 10.4 Al- 7.5 Re
70 Ti- 8 Al- 22 Re
77.9 Ti- 15.8 Al- 6.3 Re
73 Ti- 2 Al- 25 Re
87.9 Ti- 4.3 Al- 7.7 Re
For 70 wt% Ti and 2-8 wt% Al, and a balance of Re of 22-25 wt%, the Re awt.% ranges from 6.3 to 7.7, which is less than the required “at least 15 awt.% rhenium” of claim 25. Therefore, the breadth of the claim 29, which depends from claim 25, recites a composition of Ti, Al, and Re that cannot be achieved.
The inventor does not provide direction or working examples of elected metal alloy Species III. While applicant’s specification includes a table with example compositions. Exs. 11, 12, 165, 166, 174, 177, 178, and 186 broadly overlap with the metal species alloy composition elected for examination. Similarly, applicant’s specification at [0150] discloses the composition of metal alloy species III). However, for the claimed Ti and Al contents the Re content cannot be at least 15 at.% and less than 25 wt%.
Therefore, for the above cited reasons, elected metal alloy species III) with 70-91.5 wt% Ti, 2-8 wt% Al, and at least 15 awt.% and less than 25 wt% Re lacks enablement.
Claims 30-34 are rejected as depending from claim 26.
For the purpose of examination, elected metal alloy species III) will be interpreted as requiring 2-8 wt% Al and at least one of 15 awt.% Re and 70-91.5 wt% Ti.
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 26 and 29-34 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 26 lines 17-18 “III) at least 15 awt.% rhenium and 70-91.5 wt.% titanium, and…a) 2-8 wt.% aluminum” renders the claim indefinite. It is unclear how a metal alloy includes all of the recited elements within the recited ranges. The minimum required amounts, 70 wt% Ti, 2 wt% Al, 15 awt.% (50.5 wt%) Re sums to 122.5 wt%, which is more than 100 wt%. How can an alloy have more than 100 wt%? How can the amounts of the elements in the elected metal alloy satisfy the claimed requirements?
As presented evidence by the table in the 112(a) enablement rejection of claim 25, for 70 wt% Ti and 2-8 wt% Al, the Re awt.% ranges from 6.3 to 8.9 and for 91.5 wt% Ti and 2-8 wt% Al, the Re awt.% ranges from 0.1 to 1.7, both of which are less than the required “at least 15 awt.% rhenium”. Alternatively, 15.0 awt.% Re is achieved with 56.6 wt% Ti and 2 wt% Al or 48.75 wt% Ti and 8 wt% Al, where both Ti contents are outside of the required range of 70 to 91.5 wt%.
For the purpose of examination, elected metal alloy species III) will be interpreted as requiring 2-8 wt% Al and at least one of 15 awt.% Re and 70-91.5 wt% Ti.
Claim 29 line 2 “less than 25 wt.% rhenium” renders the claim indefinite. Claim 25 recites the Re content as “awt.%”. Why does dependent claim 29 change the units of rhenium to wt%? It is unclear why the same element in the same composition is being claimed as two different types of units.
Claims 30-34 are rejected as depending from claim 26.
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.
Claim 29 is 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 29 line 2 “less than 25 wt.% rhenium” fails to further limit the subject matter of the claim upon which it depends.
The metal alloy species composition of independent claim 26 elected for examination requires 70-91.5 wt% Ti, 2-8 wt% Al, and at least 15 awt.% Re. A 70-91.5 wt% Ti and 2-8 wt% Al alloy with less than 25wt% Re and at least 15 awt.% Re does not exist. In the following table Re-Ti-Al wt% compositions were converted to at% by dividing wt% by atomic weight, summing the resulting values, then dividing each individual value by the sum, as known by one of ordinary skill in the art. For 70 wt% Ti, 2-8 wt% Al, and a balance of Re of 22-25 wt%, the Re awt.% ranges from 6.3 to 7.7, which is less than the required “at least 15 awt.% rhenium”.
Composition (wt%)
Composition (at%)
70 Ti- 5 Al- 25 Re
82.1 Ti- 10.4 Al- 7.5 Re
70 Ti- 8 Al- 22 Re
77.9 Ti- 15.8 Al- 6.3 Re
73 Ti- 2 Al- 25 Re
87.9 Ti- 4.3 Al- 7.7 Re
Therefore, an alloy with “less than 25 wt.% rhenium” as required by claim 29 includes less than 15 awt.% Re. However, the elected metal alloy species of claim 26 requires at least 15 awt.% Re, such that the Re content of claims 26 and 29 are mutually exclusive and do not overlap.
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 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.
Claims 26, 29, 30, and 32-34 are rejected under 35 U.S.C. 103 as being unpatentable over Rathenow (US 2005/0079200) in view of Yamaguchi (JP H05-195119 machine translation) and Matsuno (Matsuno et al. Biocompatibility and osteogenesis of refractory metal implants, titanium, hafnium, niobium, tantalum and rhenium. Biomaterials 22 (2001) 1253-1262.).
Regarding claim 26, Rathenow discloses a medical device (implant) ([0032]-[0040]) that is at least partially formed of a metal alloy ([0041]);
said metal alloy includes:
I)at least 15 awt.% rhenium and 50-78 wt.% iron, and one or more of a) 9-27 wt.% chromium, b) 0.1-26 wt.% nickel, c) 0.01-7 wt.% molybdenum, d) 0.01-16 wt.% manganese, e) 0.01-4 wt.0% silicon, f) 0.01-2 wt.% titanium, g) 0.01-1 wt.% selenium, h) 0.01-1 wt.% niobium, i) 0.01-2 wt. % aluminum, j) 0.01-1 wt. % tantalum, k) 0.01-1 wt. % cobalt, 1) 0.01-5 wt. % copper, m) 0.01-1 wt. % vanadium, and n) 0.01-2 wt. % tungsten; or
II) at least 15 awt.% rhenium and 35-68 wt.% cobalt, and one or more of a) 12-28 wt.% chromium, b) 0.01-38 wt.% nickel, c) 0.1-30 wt.% molybdenum, d) 0.01-2 wt.% manganese, e) 0.01-1 wt. % silicon, f) 0.01-18 wt. % tungsten, g) 0.01-0.5 wt. % lanthanum, h) 0.01-20 wt. % iron, i) 0.01-5 wt.% titanium, j) 0.01-2 wt.% niobium, k) 0.01-2 wt.% aluminum, 1) 0.01-1 wt.% silicon, m) 0.01-0.5 wt.% boron, and n) 0.01-0.5 wt.% silver; or
III) 70-91.5 wt.% titanium (balance, about 88 to 91%), and one or more of a) 2-8 wt.% aluminum (5.5 to 6.75%), b) 0.01-16 wt.% vanadium, c) 0.01-1 wt.% iron, d) 0.01-0.5 wt.0% yttrium, e) 0.01-20wt.% chromium, f) 0-16 wt.% molybdenum, g) 0.01-2 wt.% nickel, h) 0.01-12 wt.% tin, i) 0.01-6 wt.% zirconium, j) 0.01-2 wt.% tantalum, k) 0.01-4 wt.% niobium, 1) 0.01-1 wt.% silicon, and m) 0.01-3 wt.% iron (Ti-6Al-1V) ([0041], [0192]); or
IV) at least 15 awt.% rhenium, 35-84 wt.% tantalum, and one or more of a) 0.1-25 wt.% tungsten, b) 0.1-30 wt.% molybdenum, c) 0.01-45 wt.% niobium, d) 0.01-5 wt.% chromium, f) 0.01-5 wt. % titanium, g) 0.01-5 wt. % zirconium, and h) 0.01-4 wt. % hafnium; or
V) at least 15 awt.% rhenium, 40-85 wt.% niobium, and one or more of a) 0.01-20 wt.% molybdenum, b) 0.01-35 wt.% tantalum, c) 0.01-12 wt.% hafnium, d) 0.01-5 wt.% zirconium, e) 0.01-3 wt.% titanium, f) 0.01-15 wt.% tungsten, and g) 0.01-1 wt.% yttrium; or
VI) at least 15 awt.% rhenium, 30-58 wt.% titanium, and 30-58 wt.% nickel; or
VII) at least 15 awt.% rhenium, and one or more of a) 1-85 awt.% chromium, b) 0.1-10 awt.% titanium, c) 0.1-10 awt.% molybdenum, and d) 0.1-10 awt.% zirconium.
Rathenow is silent to said metal alloy including rhenium in an amount of at least 15 awt.% of said metal alloy; a combined weight percent of rhenium and alloying metals is at least 70 wt.% of said metal alloy; and said metal alloy has a) an increase of at least 10% in ductility as compared to said metal alloy that is absent rhenium, and/or b) an increase of at least 10% in tensile strength.
Yamaguchi discloses a metal alloy including rhenium in an amount of at least 15 awt.% of said metal alloy (4 to 55 at% Re added to a base metal of Ti) ([0005], [0007]);
a combined weight percent of rhenium and alloying metals is at least 70 wt.% of said metal alloy (4 to 55 at% Re added to a base metal of Ti) ([0005], [0007]); and
said metal alloy has a) an increase of at least 10% in ductility as compared to said metal alloy that is absent rhenium, and/or b) an increase of at least 10% in tensile strength (excellent mechanical strength, such as tensile strength) ([0008], [0013]).
It would have been obvious to one of ordinary skill in the art in the Ti-6Al-4V base alloy of Rathenow to add 4 to 55 at% Re to form a material with excellent corrosion resistance and mechanical strength (Yamaguchi [0008]; Matsuno 4.2. The biocompatibility of implants in both soft and hard tissue, 5. Conclusion). Matsuno discloses Re implants after 4 weeks had no inflammatory response (3.2.1 Observation by optical microscopy, Fig. 4), no detected dissolution (3.2.2. Observation by X-ray scanning analytical microscope, Fig. 6, 3.3.2. Observation by electron probe microanalyzer, Fig. 9) a level of osteogenesis similar to Ti (3.3.1. Observation by optical microscopy, Fig. 8), and no evidence of inflammatory response in either soft or hard tissue (4.2. The biocompatibility of implants in both soft and hard tissue, 5. Conclusion). Therefore, adding 4 to 55 at% Re (Yamaguchi [0005], [0007]) added to a Ti-6Al-4V medical device (Rathenow [0041], [0192]) maintains the good biocompatibility and osetoconductivity (Matsuno Abstract).
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. MPEP 2144.05(I).
With respect to a) an increase of at least 10% in ductility as compared to said metal alloy that is absent rhenium, and/or b) an increase of at least 10% in tensile strength, Yamaguchi discloses excellent mechanical (tensile) strength ([0008], [0013]) by adding 4 to 55 at% Re ([0005], [0007]). Differences in concentration or temperature (or increase of ductility and/or tensile strength) will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature (or increase or ductility and/or tensile strength) is critical. “[W]here the general conditions of a claimed are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” MPEP 2144.05(II)(A).
Regarding claim 29, Rathenow in view Yamaguchi and Matsuno discloses said metal alloy includes less than 25 wt.% rhenium (adding 4 to 55 at% (about 16.75 to 497 wt%) Re to a Ti-6Al-4V base alloy) (Rathenow [0041], [0192]; Yamaguchi [0005], [0007]). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. MPEP 2144.05(I).
Regarding claim 30, Rathenow discloses said medical device (implant) ([0032]-[0040]) includes a body; said body is an expandable body (stent) ([0033], [0040]-[0041], [0150]-[0152]).
Regarding claim 32, Rathenow discloses at least one region of said medical device includes at least one biological agent (pharmacological substance) ([0107]-[0109], [0113], [0175]-[0179]).
Regarding claim 33, Rathenow discloses at least one region of said medical device includes at least one polymer ([0003], [0024]-[0027], [0042]-[0057]).
Regarding claim 34, Rathenow discloses at least one region of said medical device includes at least one polymer ([0003], [0024]-[0027], [0042]-[0057]), said at least one polymer at least partially coats, encapsulates, or combinations thereof said at least one biological agent (active principles, such as pharmacologically active substances, are on or in the (polymer) coating) ([0107], [0122]).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Rathenow (US 2005/0079200) in view of Yamaguchi (JP H05-195119 machine translation) and Matsuno (Matsuno et al. Biocompatibility and osteogenesis of refractory metal implants, titanium, hafnium, niobium, tantalum and rhenium. Biomaterials 22 (2001) 1253-1262.) as applied to claim 30 above, and as evidenced by Coroflex (Coroflex® ISAR NEO. Braun. 2016.) and Radix (Radix2. Endovascular. Renal Balloon Expandable Stent. Alvimedica. 2020.).
Regarding claim 31, Rathenow discloses said expandable body includes a plurality of struts, posts, and/or strut joints (Baun Melsungen AG, type Coroflex stent (Coroflex); Sorin Biomedica type Radix Carbostent (Radix)); said body is configured to be plastically deform radially outwardly (expand) ([0150]-[0152]; Coroflex; Radix).
Related Art
Yakolev (GB 2572609)
Yakolev discloses a titanium alloy comprising 65-95 wt% Ti, and 0-4 at% Re (Abstract, [6], [48]), where Re is a beta stabilizing element ([1]) with characteristics suited to the biomedical field as suitable for implants and superplastic materials (such as stents, US 2014/0338795 [0001], [0106]) ([45]) that undergo repetitive stress in a not easily accessible environment ([71]).
Glazunov (US 3,880,655)
Glavunoz discloses a titanium base alloy (1:3-5) for parts that operate at elevated temperatures (1:6-9) comprising 6.0 to 7.5 wt% Al, 0.05 to 0.1 wt% Re, and remainder Ti (1:32-43), where the Re obtains finer structures without deteriorating room temperature ductility (1:49-66)
Chen (CN 107904440 machine translation)
Chen discloses a high-temperature titanium alloy material ([0002]) that balances strength and toughness ([0006], [0022], [0033]) made of 6.5 to 7 mass% Al, 0.1 to 0.3 mass% Re, and balance Ti ([0008]).
Kovneristyi (Kovneristyi et al. Effect of microalloying on the elastic properties of titanium alloy VT14. Metallovedenie I Termicheskaya Obrabotka Metallov. (1988), (3), 39-40. STN abstract and composition.)
Kovneristyi discloses an alloy with 3.75 to 4.75 wt% Al and 90 to 93 wt% Ti (STN composition) with microalloying with 0.005 to 0.010 wt% Re to increase the elastic limit 10-20% and increase the relaxation resistance 2 times, while the fatigue strength remains unchanged (STN Abstract).
Liang (CN 109338158 machine translation)
Liang discloses a titanium alloy powder ([0002]) to print molds with high hardness, strength, wear resistance, and sufficient toughness ([0006]) comprising 0.01 to 0.1 parts by wt rhenium ([0013], [0033]) to solid solution strengthen and Al to ensure high temperature strength and durability ([0024], [0029]) at 2 to 4 parts by weight (abstract).
Shayakhmetova (Shayakhmetova et al. Study of the effect of rhenium on heat-resistant titanium alloy mechanical properties and microstructure. Metallurgist, Vol. 64, Nos. 11-12, March, 2021. Russian Original Nos. 11-12, November-December, 2020.)
Shayakhmetova discloses titanium alloy Ti-5Al-5Mo-5V-3Cr-1Re, where Re increases high-temperature strength and plastic deformation (Abstract, Conclusion), where the addition of large rhenium atoms complicates slip transforming it partly into twinning for which shear stress is greater, increasing strength (p. 1324 para. 3).
Micheletti (Micheletti et al. Ti-5Al-5Mo-5V-3Cr bone implants with dual-scale topography: a promising alternative to Ti-6Al-4V. Nanotechnology 31 (2020) 235101 (10pp).)
Micheletti discloses a Ti-5Al-5Mo-5V-3Cr (Ti5553) alloy for use as a bone implant for osteointegration (Abstract, 2. Materials and methods) with similar biocompatibility to Ti64 (Ti-6Al-4V) (4.2. Biocompatibility and bioactivity) and high strength (4.3. Mechanical characterization).
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 26 and 29-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 11, 15, and 23 of copending Application No. 19/375,452 (reference application, App ‘452).
Although the claims at issue are not identical, they are not patentably distinct from each other because App ‘452 discloses a medical device made of a metal alloy with an overlapping composition. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. MPEO 2144.05(I).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 26 and 29-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 43, 56, and 60 of copending Application No. 19/417,497 (App ‘497) in view of Rathenow (US 2005/0079200).
App ‘497 discloses an overlapping composition, such as a standard TiAlV alloy that includes at least 15 awt.% rhenium (claim 43). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. MPEO 2144.05(I).
App ‘497 is silent to the metal alloy being for a medical device.
Rathenow discloses a Ti6Al4V alloy medical device ([0032]-[0041], [0192]).
It would have been obvious to one of ordinary skill in the art for the alloy of App ‘497 to be used for a medical device because a standard Ti6Al4V alloy is known for such use (Rathenow [0032]-[0041], [0192]).
This is a provisional nonstatutory double patenting rejection.
Claims 26 and 29-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 33-59 of copending Application No. 19/425,047 (reference application, App ‘047).
Although the claims at issue are not identical, they are not patentably distinct from each other because App ‘047 discloses a medical device made of a metal alloy with an overlapping composition (claims 33, 43, 44, 45, 47, 48, 50, 51, 53). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. MPEO 2144.05(I).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 26 and 29-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-24 of copending Application No. 19/427,207 (reference application, App ‘207).
Although the claims at issue are not identical, they are not patentably distinct from each other because App ‘207 discloses a medical device made of a metal alloy with an overlapping composition (claims 10, 23). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. MPEO 2144.05(I).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 26 and 29-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,157,934 (US App. No. 18/434,132).
Although the claims at issue are not identical, they are not patentably distinct from each other because they recite a medical device made of a metal alloy with an overlapping composition (claims 5-13). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. MPEO 2144.05(I).
Claims 26 and 29-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-9, 11-13, 16-21, 26, 27, 29-42, 66-78 of copending Application No. 18/400,781 (reference application, App ‘781).
Although the claims at issue are not identical, they are not patentably distinct from each other because App ‘781 discloses a medical device made of a metal alloy with an overlapping composition (claims 31, 33, 34). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. MPEO 2144.05(I).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANI HILL whose telephone number is (571)272-2523. The examiner can normally be reached Monday-Friday 7am-12pm.
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, KEITH WALKER can be reached at 571-272-3458. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/STEPHANI HILL/Examiner, Art Unit 1735