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 .
Status
The original claim set filed 6/29/2023 was amended with a new claim set filed 9/8/2024, cancelling claims and putting the claim language into improved/proper format for U.S. patent prosecution. A third claim set was filed on 9/23/2024 with a header of “SUBSTITUTE SPECIFICATION CLEAN” and appears to repeat the originally filed claim set (see the 6/29/2023 original claim set). The 9/23/2024 claim set appears to be an erroneous filing, and improperly fails to further modify the amended claim set of 9/8/2024. For these reasons, the current prosecution examines the 9/8/2024 claim as being the most current, properly amended claim set of record (applicant’s claims worksheet filed 8/5/2025 further appears to confirm the 9/8/2024 claim set as being the current claim set for prosecution).
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 6/29/2023 and 8/28/2025 have been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract is objected for being greater than 150 words in length. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as "configured to" or "so that"; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Currently no claims are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 27-28 are objected to because of the following informalities:
In claim 27 (and thereby dependent claim 28), there appears to be two minor typographical errors at the start of both line 10 and line 15 wherein each line begins with a capitalized “The” (i.e., minor amendments such as “[[The]] the” will moot these minor objections).
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.
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.
Claims 1-3, 7-8, 13, 15-16, 18-19, 24 and 26-31 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 1 (and thereby dependent claims 2-3, 7-8, 13, 15-16, 18, 24 and 26) recites the limitation "the drug pharmacokinetic profile" in line 9. There is insufficient antecedent basis for this limitation in the claim. It appears that applicant may be attempting to refer back to the pre-designed drug release pharmacokinetic profile of lines 8-9, and if so, consistent use of identical claim limitation nomenclature is encouraged to eliminate any uncertainty and/or ambiguity. Appropriate correction is required.
Regarding claim 1 (and thereby dependent claims 2-3, 7-8, 13, 15-16, 18, 24 and 26), the phrase "preferably" in line 11 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(h)(II) (i.e., similar to “optionally”). It is unclear and ambiguity arises as to whether what follows “preferably” is either (1) affirmatively required as to claim scope or (2) is merely optional and can be disregarded as to claim scope. Appropriate correction is required.
Regarding claim 1 (and thereby dependent claims 2-3, 7-8, 13, 15-16, 18, 24 and 26), the phrase "preferably" in line 12 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(h)(II) (i.e., similar to “optionally”). It is unclear and ambiguity arises as to whether what follows “preferably” is either (1) affirmatively required as to claim scope or (2) is merely optional and can be disregarded as to claim scope. Appropriate correction is required.
Claim 1 (and thereby dependent claims 2-3, 7-8, 13, 15-16, 18, 24 and 26) recites the limitation "the kinetic profile" in line 14. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Regarding claim 1 (and thereby dependent claims 2-3, 7-8, 13, 15-16, 18, 24 and 26), the phrase "preferably" in line 16 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(h)(II) (i.e., similar to “optionally”). It is unclear and ambiguity arises as to whether what follows “preferably” is either (1) affirmatively required as to claim scope or (2) is merely optional and can be disregarded as to claim scope. Appropriate correction is required.
Regarding claim 1 (and thereby dependent claims 2-3, 7-8, 13, 15-16, 18, 24 and 26), the phrase "preferably" in line 17 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(h)(II) (i.e., similar to “optionally”). It is unclear and ambiguity arises as to whether what follows “preferably” is either (1) affirmatively required as to claim scope or (2) is merely optional and can be disregarded as to claim scope. Appropriate correction is required.
Regarding claim 1 (and thereby dependent claims 2-3, 7-8, 13, 15-16, 18, 24 and 26), the phrase "optionally" in line 20 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(h)(II). It is unclear and ambiguity arises as to whether what follows “optionally” is either (1) affirmatively required as to claim scope or (2) is truly optional and can be disregarded as to claim scope. Appropriate correction is required.
Claim 2 recites the limitation "the stent" in line 3. There is insufficient antecedent basis for this limitation in the claim. It appears that applicant may be attempting to refer back to the stent framework of line 2 of claim 1, and if so, consistent use of identical claim limitation nomenclature is encouraged to eliminate any uncertainty and/or ambiguity. Appropriate correction is required.
Regarding claim 3 (and thereby dependent claim 7), the phrase "preferably" in line 4 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(h)(II) (i.e., similar to “optionally”). It is unclear and ambiguity arises as to whether what follows “preferably” is either (1) affirmatively required as to claim scope or (2) is merely optional and can be disregarded as to claim scope. Appropriate correction is required.
Regarding claim 3 (and thereby dependent claim 7), the phrase "preferably" in line 32 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(h)(II) (i.e., similar to “optionally”). It is unclear and ambiguity arises as to whether what follows “preferably” is either (1) affirmatively required as to claim scope or (2) is merely optional and can be disregarded as to claim scope. Appropriate correction is required.
Regarding claim 8, the phrase "preferably" in line 2 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(h)(II) (i.e., similar to “optionally”). It is unclear and ambiguity arises as to whether what follows “preferably” is either (1) affirmatively required as to claim scope or (2) is merely optional and can be disregarded as to claim scope. Appropriate correction is required.
Regarding claim 13 (and thereby dependent claims 16 and 18), the phrase "optionally" used twice in line 6 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(h)(II). It is unclear and ambiguity arises as to whether what follows “optionally” is either (1) affirmatively required as to claim scope or (2) is truly optional and can be disregarded as to claim scope. Appropriate correction is required.
Regarding claim 13 (and thereby dependent claim 16 and 18), the phrase "preferably" in line 7 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(h)(II) (i.e., similar to “optionally”). It is unclear and ambiguity arises as to whether what follows “preferably” is either (1) affirmatively required as to claim scope or (2) is merely optional and can be disregarded as to claim scope. Appropriate correction is required.
Regarding claim 16, the phrase "preferably" in line 2 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(h)(II) (i.e., similar to “optionally”). It is unclear and ambiguity arises as to whether what follows “preferably” is either (1) affirmatively required as to claim scope or (2) is merely optional and can be disregarded as to claim scope. Appropriate correction is required.
Claim 19 recites the limitation "the product parameters" in line 1. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 19 recites the limitation "the stent" in line 2. There is insufficient antecedent basis for this limitation in the claim. It appears that applicant may be attempting to refer back to the drug eluting stent of lines 1-2, and if so, consistent use of identical claim limitation nomenclature is encouraged to eliminate any uncertainty and/or ambiguity. Appropriate correction is required.
Regarding claim 19, the phrase "e.g." (interpreted as “for example”) in line 3 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). Appropriate correction is required.
Claim 19 recites the limitation "the percentage of neointima coverage" in line 4. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Regarding claim 19, the phrase "a stent" in line 5 renders the claim(s) indefinite because a drug eluting stent was already introduced in lines 1-2, thereby rendering the scope of the claim(s) unascertainable. It is unclear whether applicant intended to refer back to the drug eluting stent of lines 1-2 claim or introduce a new, additional stent. To move prosecution forward, the examiner assumed applicant intended to refer back to the drug eluting stent of lines 1-2. Appropriate correction is required.
Regarding claim 19, the phrase "preferably" in line 7 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(h)(II) (i.e., similar to “optionally”). It is unclear and ambiguity arises as to whether what follows “preferably” is either (1) affirmatively required as to claim scope or (2) is merely optional and can be disregarded as to claim scope. Appropriate correction is required.
Regarding claim 19, the phrase "may be" in line 12 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(h)(II) (i.e., similar to “optionally”). It is unclear and ambiguity arises as to whether what follows “may be” is either (1) affirmatively required as to claim scope or (2) is merely optional and can be disregarded as to claim scope. Appropriate correction is required.
Regarding claim 19, the phrase "preferably" in line 13 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(h)(II) (i.e., similar to “optionally”). It is unclear and ambiguity arises as to whether what follows “preferably” is either (1) affirmatively required as to claim scope or (2) is merely optional and can be disregarded as to claim scope. Appropriate correction is required.
Regarding claim 19, the phrase "preferably" in line 16 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(h)(II) (i.e., similar to “optionally”). It is unclear and ambiguity arises as to whether what follows “preferably” is either (1) affirmatively required as to claim scope or (2) is merely optional and can be disregarded as to claim scope. Appropriate correction is required.
Regarding claim 24 (and thereby dependent claim 26), the phrase "preferably" in line 4 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(h)(II) (i.e., similar to “optionally”). It is unclear and ambiguity arises as to whether what follows “preferably” is either (1) affirmatively required as to claim scope or (2) is merely optional and can be disregarded as to claim scope. Appropriate correction is required.
Regarding claim 24 (and thereby dependent claim 26), the phrase "preferably" in line 5 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(h)(II) (i.e., similar to “optionally”). It is unclear and ambiguity arises as to whether what follows “preferably” is either (1) affirmatively required as to claim scope or (2) is merely optional and can be disregarded as to claim scope. Appropriate correction is required.
Claim 27 (and thereby dependent claims 28-31) recites the limitation "the stent" in line 6. There is insufficient antecedent basis for this limitation in the claim. It appears that applicant may be attempting to refer back to the stent framework of line 2, and if so, consistent use of identical claim limitation nomenclature is encouraged to eliminate any uncertainty and/or ambiguity. Appropriate correction is required.
Claim 28 recites the limitation "the drug pharmacokinetic profile" in line 4. There is insufficient antecedent basis for this limitation in the claim. It appears that applicant may be attempting to refer back to the pre-designed drug release pharmacokinetic profile of lines 2-3, and if so, consistent use of identical claim limitation nomenclature is encouraged to eliminate any uncertainty and/or ambiguity. Appropriate correction is required.
Regarding claim 28, the phrase "preferably" in line 6 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(h)(II) (i.e., similar to “optionally”). It is unclear and ambiguity arises as to whether what follows “preferably” is either (1) affirmatively required as to claim scope or (2) is merely optional and can be disregarded as to claim scope. Appropriate correction is required.
Regarding claim 28, the phrase "preferably" in line 7 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(h)(II) (i.e., similar to “optionally”). It is unclear and ambiguity arises as to whether what follows “preferably” is either (1) affirmatively required as to claim scope or (2) is merely optional and can be disregarded as to claim scope. Appropriate correction is required.
Claim 28 recites the limitation "the kinetic profile" in line 9. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Regarding claim 28, the phrase "preferably" in line 11 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(h)(II) (i.e., similar to “optionally”). It is unclear and ambiguity arises as to whether what follows “preferably” is either (1) affirmatively required as to claim scope or (2) is merely optional and can be disregarded as to claim scope. Appropriate correction is required.
Regarding claim 28, the phrase "preferably" in line 12 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(h)(II) (i.e., similar to “optionally”). It is unclear and ambiguity arises as to whether what follows “preferably” is either (1) affirmatively required as to claim scope or (2) is merely optional and can be disregarded as to claim scope. Appropriate correction is required.
Regarding claim 28, the phrase "optionally" in line 15 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(h)(II). It is unclear and ambiguity arises as to whether what follows “optionally” is either (1) affirmatively required as to claim scope or (2) is truly optional and can be disregarded as to claim scope. Appropriate correction is required.
Regarding claim 29, the phrase "a stent" in line 3 renders the claim(s) indefinite because a drug eluting stent was already introduced in line 1, thereby rendering the scope of the claim(s) unascertainable. It is unclear whether applicant intended to refer back to the drug eluting stent of line 1 or introduce a new, additional stent. To move prosecution forward, the examiner assumed applicant intended to refer back to the drug eluting stent of lines 1. Appropriate correction is required.
Claim 30 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 30 appears to fail to further limit the subject matter of claim 29 upon which it depends (i.e., 80%-100% neointima strut coverage achieved between day 20 and day 60 is already required in claim 29). 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. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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) 19 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sun et al. (US 2019/0365959).
Sun discloses (see Fig. 10) a method of selecting product parameters of a drug eluting stent comprising the following claim limitations:
(claim 19) A method of:
selecting the product parameters of a drug eluting stent ([0262]-[0265]; selecting the product parameters of the layers of a drug eluting stent expressly disclosed) and/or (as steps (i) and (ii) are claimed and interpreted in the alternative (i.e., see “and/or” in line 2 of claim 19), any prior art satisfying step (i) therefore reads on claim 19, and step (ii) does not need to be disclosed or taught to reject claim 19 in view of the prior art disclosure);
(ii) predicting the outcome of the stent implantation at 1-year or more post-stent implantation (e.g., thrombosis), comprising preparing the stent and measuring the percentage of neointima coverage over the stent in the arterial tissue where a stent is implanted at 30 days post-stent implantation, wherein the higher the percentage of neointima coverage over the stent at 30 days, the better the stent in terms of stent efficacy and/or safety; preferably, wherein the percentage of neointima coverage over the implanted stent at about 30 days/1 month is predictive of stent implantation side effects at 1-year or more post-stent implantation, wherein a 80-90% neointima coverage at about 30 days/1 month is representative or predictive of low side effects at 1-year post-stent implantation; and/or, wherein the percentage of neointima coverage may be assessed by measuring strut coverage, preferably at about 30 days/1 month; and/or wherein a covered strut is a strut having a neointimal thickness above 0, preferably above 20, micrometers above the surface of the strut.
Allowable Subject Matter
Claims 1-3, 7-8, 13, 15-16, 18, 24 and 26-31 are acknowledged to contain allowable subject matter and are not subject to prior art rejections herein. However, claims 1-3, 7-8, 13, 15-16, 18, 24 and 26-31 remain subject to claim objections and/or 112 rejections that must be resolve before any of these claims can be in proper condition for allowance. The closest prior art reference appears to be Sun et al. (US 2019/0365959) that discloses a similar drug eluting stent, but fails to disclose the pre-designed pharmacokinetic profile having both the Tmax (time of maximum observed concentration) and Cmax (maximum concentration achieved) and/or both the ratio R and cell shape index I, as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771