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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
Status of the Claims
Claim(s) 1-24 is/are pending. Claim(s) 5-7 and 13-24 is/are withdrawn.
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-12, drawn to a device having a first leg element and first and second loops.
Group II, claim(s) 13-24, drawn to a device having first and second leg elements and first and second loops.
This application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1.
The species are as follows:
Species of material
Species 1-1: photo-curable polymer (e.g. claims 3, 15)
Species 1-2: composite of a polymer and a plurality of micro-nanoparticles (e.g. claims 5, 17)
Species 1-3: mixture of conductive materials (e.g. claims 6, 18)
Species 1-4: poly urethane shape memory polymer (e.g. claims 7, 19)
Applicant is required, in reply to this action, to elect a single species to which the claims shall be restricted if no generic claim is finally held to be allowable. The reply must also identify the claims readable on the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered non-responsive unless accompanied by an election.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim. Currently, the following claim(s) are generic: claim 1.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Each of (1) Groups I and II and (2) Species 1-1 to 1-4 lack unity of invention because even though the inventions of these groups require the technical feature of claim 1, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Steinke, et al (Steinke) (US 6,033,436).
Steinke teaches a device (e.g. Figure 3, abstract), comprising:
a first leg element (e.g. Figure 3, #36) made by three dimensional printing (this is a product-by-process limitation discussed below), the first leg element having a first end and a second end at each end of a longitudinal member (e.g. Figure 3);
a first loop attached adjacent the first end of the first leg element (e.g. Figure 3, one of #s 30);
a second loop attached adjacent the second end of the first leg element (e.g. Figure 3, the other #30); and
the first and second loops made by three dimensional printing (this is a product-by-process limitation discussed below).
See also prior art rejection section below.
During a telephone conversation with Roshan Bhattarai on 2/19/2026 a provisional election was made without traverse to prosecute the invention of Group I and Species 1-1, claims 1-4 and 8-12. Affirmation of this election must be made by applicant in replying to this Office action. Claims 5-7 and 13-24 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Objections
Claims 1 and 3-4 are objected to because of the following informalities:
Each of Claim 1, line 6 and claim 3, line 1 and claim 4, line 2 recites “the first and second”, which should be “the first and the second”.
Appropriate correction is required.
Product By Process
The Examiner recognizes claims 1 and 8 as a "product-by-process" claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (see MPEP 2113).
As a product claim, Examiner has determined claims 1 and 8 require the device to comprise the following structural elements in addition to those in the claims from which they depend.
Claim 1: a first leg element with first and second ends, a first loop adjacent the first end, and a second loop adjacent the second end.
Claim 8: the features of claim 1 plus (1) a second device having its own respective first leg element with first and second ends, a first loop adjacent the first end, and a second loop adjacent the second end and (2) the device and the second device connected to each other.
In the prior art rejection in this Office action, Examiner considers claims 1 and 8 to be met when a reference teaches these structural limitations.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8-12 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 8, lines 3 recites “a longitudinal member”. It is unclear if this limitation is the same or different than that introduced in claim 1 for the device of claim 1. For purposes of examination the Examiner considers this language to be “a second longitudinal member”.
Claim 8, lines 4-5 recites the following limitations. In each case, it is unclear what instance of the limitation is being referred back to – that introduced earlier in claim 1 or that introduced earlier in claim 8.
Limitation
For purposes of examination the Examiner considers this language to be:
“the first end”
“the first end of the first leg element of the second device”
“the first leg element”
“the first leg element of the second device”
“the second end”
“the second end of the first leg element of the second device”
Claim(s) 9-12 are rejected as dependent from a rejected claim.
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) 1-2 and 8-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gambale, et al (Gambale) (US 2004/0186557 A1).
Regarding Claim 1, Gambale a device (e.g. Figures 15C-D; one of the wires 148, 150), comprising:
a first leg element (e.g. annotated Figures 15C below; section between the two added straight lines with circular ends) made by three dimensional printing (see product-by-process limitation discussion supra), the first leg element having a first end and a second end at each end of a longitudinal member (e.g. annotated Figure 15C below; ends directly connected to the respective loops; longitudinal member extends between these ends);
a first loop attached adjacent the first end of the first leg element (e.g. annotated Figure 15C below; one full turn of the coil);
a second loop attached adjacent the second end of the first leg element (e.g. annotated Figure 15C below; one full turn of the coil); and
the first and second loops made by three dimensional printing (see product-by-process limitation discussion supra).
PNG
media_image1.png
584
1286
media_image1.png
Greyscale
Annotated Figure 15C, Gambale
Regarding Claim 2, the first leg element has a cylindrical shape (e.g. Figure 15A).
Regarding Claim 8, there is a second device (e.g. annotated Figure 15C above; the other of the #s 148, 150; section between the two added straight lines with square ends) made with three dimensional printing (see product-by-process limitation discussion supra)
having a second device first leg element having a first end and a second end at each end of a longitudinal member (e.g. annotated Figure 15C above),
a first loop of the second device attached adjacent the first end of the first leg element (e.g. annotated Figure 15C above) and
a second loop of the second device attached adjacent the second end of the first leg element (e.g. annotated Figure 15C above) and
wherein the device and the second device are connected to each other (e.g. annotated Figure 15C above).
Regarding Claim 9, the device and the second device slide relative to each other when assembled (e.g. Figures 15C-D, the (first) device and the second devices are able to move independently of each other and thus they are able to slide relative to one another).
Regarding Claim 10, the device and the second device are connected in a line with each other (e.g. annotated Figure 15C above).
Regarding Claim 11, a plurality of devices are connected in pairs to each other (e.g. annotated Figure 15C above; (first) device and second device).
Regarding Claim 12, a plurality of devices are connected together in a circuit (e.g. annotated Figure 15C above).
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gambale, et al (Gambale) (US 2004/0186557 A1) as discussed supra and further in view of Langer, et al (Langer) (US 6,160,084 A).
Regarding Claim 3, Gambale teaches stents made of a polymer material (e.g. [0092], [0105], [0109]).
However, Gambale discloses the invention substantially as claimed but fails to teach the first leg element and the first and second loops are each made of a photo-curable polymer.
Langer teaches the use of specifically photo-curable polymer materials in stents (e.g. column 3, lines 44-48; column 11, lines 17-23).
Langer and Gambale are concerned with the same field of endeavor as the claimed invention, namely polymer stents.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gambale such that the specific polymer material is that as taught by Langer as it is a simple substitution of one known element (stent polymer) for another to obtain predictable results (MPEP 2143(I)) of an implantable stent of a known material for stents.
Regarding Claim 4, Gamble teaches the use of a drug (e.g. [0016]).
However, Gambale discloses the invention substantially as claimed but fails to teach there is a drug embedded in the first leg element and the first and second loops.
Langer teaches a polymer materials for stents (discussed supra for claim 3) that have therapeutic agents embedded into the polymer material (e.g. column 11, lines 36-40).
Langer and Gambale are concerned with the same field of endeavor as the claimed invention, namely polymer stents.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gambale such that the drug is specifically embedded within the polymer as taught by Langer as it is a simple substitution of one known element for another to obtain predictable results (MPEP 2143(I)) of delivering a drug over time.
Relevant Prior Art
US 2009/0270974 to Berez, et al teaches a device having a leg element with first and second loops at its respective ends (e.g. Figure 2B).
US 2006/0020324 to Schmid, et al teaches first and second devices each having a leg element having two loops at its respective ends (e.g. annotated Figures 4B and 18 below).
PNG
media_image2.png
482
692
media_image2.png
Greyscale
Annotated Figure 4B, Schmid
PNG
media_image3.png
546
1107
media_image3.png
Greyscale
Annotated Figure 18, Schmid
US 2009/0143853 to Morris, et al teaches first and second devices each having a leg element having two loops at its respective ends (e.g. Figures 4, 7).
US 2001/0044651 to Steinke teaches first and second devices each having a leg element having two loops at its ends (e.g. Figures 3, 10).
PNG
media_image4.png
722
762
media_image4.png
Greyscale
Annotated Figure 4B, Steinke
US 2014/0277375 to Weier, et al teaches first and second devices each having a leg element having two loops at its ends (e.g. Figures 7-8).
US 2019/0053924 to Choi, et al teaches first and second devices each having a leg element having two loops at its respective ends (e.g. Figure 14).
US 6,224,626 B1 to Steinke teaches first and second devices each having a leg element having two loops at its ends (e.g. Figures 3, 5).
US 5,549,662 to Fordenbacher teaches first and second devices each having a leg element having two loops at its respective ends (e.g. Figure 1).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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, THOMAS BARRETT can be reached at (571)272-4746. 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.
/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 2/27/2026