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
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in CN202410199022.9 on 02/22/2024. It is noted, however, that applicant has not filed a certified copy of the foreign application as required by 37 CFR 1.55.
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-6, drawn to a vascular stent, classified in A61L 2300/606.
II. Claims 7-8, drawn to a method of manufacturing a vascular stent, classified in a A61l 2300/45.
The inventions are independent or distinct, each from the other because:
Inventions II. and I. are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case, the claimed stent could be manufactured using a materially different process such as 3D printing and/ liposomal disposition of drugs.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
--the species or groupings of patentably indistinct species have acquired a separate status in the art in view of their different classification;
--the species or groupings of patentably indistinct species have acquired a separate status in the art due to their recognized divergent subject matter; and/or
--the species or groupings of patentably indistinct species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
-For a serious examination burden explain the reason, such as non-prior art issues under 35 U.S.C. 101, pre-AIA 35 U.S.C. 112, first paragraph, and/or 35 U.S.C. 112(a) are relevant to one species or grouping of patentably indistinct species that are not relevant to the other species or grouping(s) of patentably indistinct species. Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these 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.
During a telephone conversation with Lei Leong on a provisional election was made without traverse to prosecute the invention of Group I, claims 1-6 . Affirmation of this election must be made by applicant in replying to this Office action. Claims 7-8 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).
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts. Abstract is not in narrative form and uses legal phraseology, “The present disclosure provides a vascular stent and a manufacturing process therefor” and “present disclosure”. Examiner suggests removing phrases cited and rewriting the abstract to be in narrative form. Appropriate correction is required.
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 1-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1 and 4, the phrase "comprises but not limited to" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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) 1-6 is/are rejected under 35 U.S.C. 102(1)(1) as being anticipated by Fritz et al. US 20090004240 A1, herein disclosed as Fritz.
Regarding claim 1, Fritz discloses a vascular stent ([0005]), wherein the vascular stent is loaded with an endothelial protein C receptor (EPCR) activator ([0022]; activated C protein loading tauch) and a limus drug (a class of potent medications—primarily mTOR inhibitors—used to prevent cell proliferation, suppress the immune system, and stop blood vessels from narrowing; [0022] taught rapamycin is a known mTOR inhibitor), and the manner of loading comprises but not limited to spraying and wrapping ([0039]).
Regarding claim 2, Fritz discloses wherein the EPCR activator is one or more of activated protein C [0022], TR47 and Parmodulin 2.
Regarding claim 3, Fritz discloses wherein the limus drug comprises one or more of rapamycin and tacrolimus ([0022]).
Regarding claim 4, Fritz discloses wherein the spraying comprises but not limited to spraying a coating of an EPCR activator and a limus drug on a metal stent ([0026] teaches metal stent; [0039]); and the wrapping comprises but not limited to wrapping the EPCR activator and the limus drug in a bioresorbable stent ([0039] sublimation also taught).
Regarding claim 5, Fritz discloses wherein the spraying amounts of the EPCR activator and the limus drug are 1 ug/mm-100 ug/mm ([0024-0025]; While Fritz does not teach the specific range, the claimed ranges are within the ranges taught by Frtiz) and 1 ug/mm-100 ug/mm (([0024-0025]; While Fritz does not teach the specific range, the claimed ranges are within the ranges taught by Frtiz) respectively.
Regarding claim 5, Fritz discloses wherein the wrapping (Merriam Webster defines wrap: To "wrap" means to cover, enclose, or wind something around an object; coating taught by Fritz applies, see [0031]) amounts of the EPCR activator and the limus drug are 1 ug/mm-100 ug/mm ([0024-0025]; While Fritz does not teach the specific range, the claimed ranges are within the ranges taught by Frtiz) and 1 ug/mm-100 ug/mm (([0024-0025]; While Fritz does not teach the specific range, the claimed ranges are within the ranges taught by Frtiz) respectively.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Nur et al. US 20110045034 A1 discloses a biocompatible preparation.
Huang et al. US 20160045345 A1 discloses an intravascular stent featuring drug elution
Achneck et al. US 20120141562 A1 discloses cell coated implantable device.
Jackson et al. US 20200155730 A1 discloses compositions and devices incorporating water-insoluble therapeutic agents and methods of the use thereof.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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, Melanie Tyson can be reached at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.F./
Patent Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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