DETAILED ACTION
Claims 1-5 and 33-47 are pending, and claims 1-5 and 33-35 are currently under review.
Claims 6-32 are cancelled.
Claims 36-47 are withdrawn.
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 Amendment
The amendment filed 6/04/2026 has been entered. Claims 1-5 and newly submitted claim(s) 33-47 remain(s) pending in the application. Applicant’s amendments to the Claims have overcome each and every 112 rejection previously set forth in the Non-Final Office Action mailed 3/09/2026.
Election/Restrictions
Newly submitted claims 36-47 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claims 36-47 are directed to an article, wherein the shared technical feature between the article and previously presented alloy does not distinguish over the prior art such that there is a lack of unity of invention.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 36-47 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Interpretation
The term “consisting essentially of” limits the claimed alloy composition to only the recited elements, as well as those that do not materially affect the basic and novel characteristics of the claimed alloy. However, absent a specific and clear indication of said basic and novel characteristics, the term “consisting essentially of” must be construed to have the same scope as “comprising”. See MPEP 2111.03(III). Since the instant specification and claims do not clearly indicate what properties constitute “basic” and “novel” characteristics, the examiner must interpret the claims to be equivalent to “comprising” as stated above.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (2011, In vitro investigation of Fe30Mn6Si shape memory alloy as potential biodegradable metallic material).
Regarding claims 1-5, Liu et al. discloses a shape memory alloy having a composition of Fe30Mn6Si having promising biodegradability properties [abstract, p.540]. The examiner notes that this composition of Liu et al. is substantially close to the claimed ranges such that prima facie obviousness exists because similar properties would have been expected to be present. See MPEP 2144.5(I). Indeed, Liu et al. expressly teaches identical properties of shape memory characteristics and biodegradability as already stated above.
Claim(s) 33-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (2011, In vitro investigation of Fe30Mn6Si shape memory alloy as potential biodegradable metallic material) in view of Findik et al. (WO2017188908).
Regarding claims 33-35, Liu et al. discloses the alloy of claim 1 (see previous). Liu et al. does not expressly teach manufacturing the alloy through methods as claimed. Findik et al. discloses that it is well known to manufacture biodegradable shape memory FeMnSi alloys through additive manufacturing means such as laser melting such that custom fabrication can be performed [p.1-3]. Therefore, it would have been obvious to one of ordinary skill to modify the alloy of Liu et al. by fabricating said alloy through laser melting additive manufacturing for the aforementioned benefit of Findik et al. The examiner notes that powder bed fusion is a common and well-known means of laser melting additive manufacturing. Nonetheless, it is further noted that powder bed fusion is a product-by-process limitation which is not considered to impart any further distinct structure to the claimed alloy absent concrete evidence to the contrary because the mere presence/placement of powders in a bed has no material significance over the laser melting of Findik et al. See MPEP 2113.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mori et al. (US 4,780,154).
Regarding claim 1, Mori et al. discloses a shape memory alloy for use in several applications including medical devices, which one of ordinary skill would recognize to require some degree of biodegradability [col.1 ln.15-40]. Mori et al. discloses that said shape memory alloy has a composition as seen in table 1 below, which meets the claimed components [col.2 ln.13-21].
Table 1.
Element (wt.%)
Claim 1 (wt.%)
Mori et al. (wt.%)
Fe
Present
Balance
Mn
Present
20 – 40
Si
Present
3.5 – 8
Regarding claims 2-5, Mori et al. discloses the alloy of claim 1 (see previous). The examiner notes that the aforementioned composition of Mori et al. further overlaps with the claimed ranges, which is prima facie obvious. See MPEP 2144.05(I).
Claim(s) 33-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mori et al. (US 4,780,154) in view of Findik et al. (WO2017188908).
Regarding claims 33-35, Mori et al. discloses the alloy of claim 1 (see previous). Mori et al. does not expressly teach manufacturing the alloy through methods as claimed. Findik et al. discloses that it is well known to manufacture biodegradable shape memory FeMnSi alloys through additive manufacturing means such as laser melting such that custom fabrication can be performed [p.1-3]. Therefore, it would have been obvious to one of ordinary skill to modify the alloy of Mori et al. by fabricating said alloy through laser melting additive manufacturing for the aforementioned benefit of Findik et al. The examiner notes that powder bed fusion is a common and well-known means of laser melting additive manufacturing. Nonetheless, it is further noted that powder bed fusion is a product-by-process limitation which is not considered to impart any further distinct structure to the claimed alloy absent concrete evidence to the contrary because the mere presence/placement of powders in a bed has no material significance over the laser melting of Findik et al. See MPEP 2113.
Claim(s) 1-5 and 33-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shuai et al. (CN112359263, machine translation referred to herein).
Regarding claims 1-4 and 33-35, Shuai et al. discloses a biodegradable iron alloy having stress-induced martensitic transformation, which one of ordinary skill would understand to correlate to a shape memory effect [0002]. Shuai et al. further discloses an iron alloy composition of 28 to 32 weight percent Mn and 5 to 7 weight percent Si, which overlaps with the claimed ranges [0016]. See MPEP 2144.05(I). Shuai et al. also discloses manufacturing the alloy through laser melting by scanning powder layers, which meets the limitations of powder bed fusion additive manufacturing as claimed [0025]. The examiner alternatively notes that although Shuai et al. does not expressly teach a shape memory effect, said shape memory effect is directly achieved by controlling alloy composition and manufacturing as recognized by one of ordinary skill. Shuai et al. expressly discloses an overlapping composition and identical method of manufacture, such that a substantially similar shape memory effect would have naturally flowed. See MPEP 2112 & MPEP 2144.05(I).
Regarding claim 5, Shuai et al. discloses the alloy of claim 1 (see previous). The examiner notes that this composition of Shuai et al. is substantially close to the claimed ranges such that prima facie obviousness exists because similar properties would have been expected to be present. See MPEP 2144.5(I). Indeed, Shuai et al. expressly teaches identical properties of shape memory characteristics and biodegradability as already stated above.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Drevet et al. (2018, Martensitic transformation and mechanical and corrosion properties for Fe-Mn-Si alloys for biodegradable medical implants).
Regarding claims 1-5, Drevet et al. discloses a biodegradable alloy displaying a reversible martensitic transformation (ie. shape memory) [p.1006-1007]. Drevet et al. further teaches several sample compositions of FeMnSi wherein Si is fixed at 5 weight percent and Mn is selected to be 23, 26, and 30 weight percent [p.1007]. The examiner submits that these samples of Drevet et al. reasonably suggest a Mn range of 23 to 30 weight percent, which overlaps with the claimed ranges. See MPEP 2144.05(I).
Claim(s) 33-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Drevet et al. (2018, Martensitic transformation and mechanical and corrosion properties for Fe-Mn-Si alloys for biodegradable medical implants) in view of Findik et al. (WO2017188908).
Regarding claims 33-35, Drevet et al. discloses the alloy of claim 1 (see previous). Drevet et al. does not expressly teach manufacturing the alloy through methods as claimed. Findik et al. discloses that it is well known to manufacture biodegradable shape memory FeMnSi alloys through additive manufacturing means such as laser melting such that custom fabrication can be performed [p.1-3]. Therefore, it would have been obvious to one of ordinary skill to modify the alloy of Drevet et al. by fabricating said alloy through laser melting additive manufacturing for the aforementioned benefit of Findik et al. The examiner notes that powder bed fusion is a common and well-known means of laser melting additive manufacturing. Nonetheless, it is further noted that powder bed fusion is a product-by-process limitation which is not considered to impart any further distinct structure to the claimed alloy absent concrete evidence to the contrary because the mere presence/placement of powders in a bed has no material significance over the laser melting of Findik et al. See MPEP 2113.
Response to Arguments
Applicant's arguments filed 6/04/2026 regarding the 103 rejections have been fully considered but they are not persuasive.
Applicant argues that Mori et al. requires inclusion of at least one other non-recited element, which does not meet the claim scope. The examiner cannot concur. Firstly, Mori et al. never requires the presence of elements besides Fe, Mn, and Si. The examiner’s position is bolstered by specific examples of Mori et al. which do not include further elements [table1]. Nonetheless, as explained above, the recitation of “consisting essentially of…” must be construed to be equivalent to “comprising” such that applicant’s arguments are moot.
Applicant argues that medical devices do not require at least some degree of biodegradability. The examiner cannot concur. One of ordinary skill would readily recognize that shape memory medical devices as disclosed by Mori et al. would have at least some degree of biodegradability. This is expressly disclosed in the introduction sections of the prior art of Findik et al. or Shuai et al. above, for example.
Applicant then argues that the claimed ranges achieve critical and unexpected results. In response, the examiner cannot concur absent a clear indication and explanation of said critical and unexpected results as they are commensurate in scope with the claimed ranges, which has not been provided. It is noted that burden falls to applicant to provide clear evidence and explanation of unexpected and critical results. See MPEP 716.02(b) & MPEP 2144.05(III)(A).
The previous 102 rejections are withdrawn in view of applicant’s amendments.
Applicant’s arguments regarding the newly amended limitations have been considered but are further moot in view of the new grounds of rejection above.
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 NICHOLAS A WANG whose telephone number is (408)918-7576. The examiner can normally be reached usually M-Th: 7-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jonathan Johnson can be reached at 5712721177. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS A WANG/Primary Examiner, Art Unit 1734
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