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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 8/18/2023 and 9/5/2023 has/have been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
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
Claim 5 is objected to because of the following informalities:
In claim 5, there is an instance of rough grammar in line 8 at “a step of further providing other layer” (wherein a minor amendment such as “a step of further providing another an additional .
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) 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fan et al., Development of Antimicrobial and Antifouling Universal Coating via Rapid Deposition of Polydopamine and Zwitterionization (Langmuir 2019, 35, 1642-1651) (see IDS dated 8/18/2023).
Fan discloses medical devices coated with polydopamine and methods of coating medical devices comprising the following claim limitations:
(claim 1) An agent for suppressing adhesion of calculi or calcification comprising polydopamine and/or a derivative thereof (see Abstract; Introduction section, pp.1642-1643; Antimicrobial Coating and Catheter section, p. 1644; Results and Discussion section, p. 1644; Antifouling and Antimicrobial Coatings on Silicone-based Urinary Catheters section, p. 1648; Conclusion section, pp. 1648-1649; a urinary catheter having a polydopamine coating is expressly disclosed), wherein the agent for suppressing adhesion of calculi or calcification is used to form at least an outermost surface of a coating layer of a medical device to be retained in a urinary organ or a circulatory organ (see Abstract; Introduction section, pp.1642-1643; Antimicrobial Coating and Catheter section, p. 1644; Results and Discussion section, p. 1644; Antifouling and Antimicrobial Coatings on Silicone-based Urinary Catheters section, p. 1648; Conclusion section, pp. 1648-1649; a urinary catheter having an outer coating of polydopamine is expressly disclosed);
(claim 2) wherein the polydopamine and/or the derivative thereof is obtained by a reacting for 1 to 5 days in a reaction solution of pH 8.3 to 10 containing dopamine and/or a derivative thereof at a concentration of 5 to 16 mM (Deposition of pDA on Substrates section, p. 1643; polydopamine layer coating by a reaction of dopamine solution at 2 mg/mL (approximately equivalent to 13 mM) in a solution at pH 8.5 for 20-120 minutes) (additionally the claim language is interpreted as a product-by-process claim as the device of Fan appear to be substantially identical to the device claimed, although produce by a potentially different process, therefore the burden is upon the applicant to come forward with evidence establishing an unobvious difference between the two; In re Marosi, 218 USPQ 289 (Fed. Cir. 1983)).
(claim 3) wherein the medical device is a ureteral stent, a renal pelvis catheter, a urethral catheter, or an artificial blood vessel (see Abstract; Introduction section, pp.1642-1643; Antimicrobial Coating and Catheter section, p. 1644; Results and Discussion section, p. 1644; Antifouling and Antimicrobial Coatings on Silicone-based Urinary Catheters section, p. 1648; Conclusion section, pp. 1648-1649; a urinary catheter having a polydopamine coating is expressly disclosed);
(claim 4) A medical device less susceptible to adhesion of calculi or calcification, the medical device comprising: a medical device to be retained in a urinary organ or a circulatory organ (see Abstract; Introduction section, pp.1642-1643; Antimicrobial Coating and Catheter section, p. 1644; Results and Discussion section, p. 1644; Antifouling and Antimicrobial Coatings on Silicone-based Urinary Catheters section, p. 1648; Conclusion section, pp. 1648-1649; a urinary catheter having a polydopamine coating is expressly disclosed); and a coating layer provided on a surface of the medical device, wherein at least an outermost surface of the coating layer is a layer containing polydopamine and/or a derivative thereof (see Abstract; Introduction section, pp.1642-1643; Antimicrobial Coating and Catheter section, p. 1644; Results and Discussion section, p. 1644; Antifouling and Antimicrobial Coatings on Silicone-based Urinary Catheters section, p. 1648; Conclusion section, pp. 1648-1649; a urinary catheter having an outer coating of polydopamine is expressly disclosed); and
(claim 5) A method for manufacturing a medical device less susceptible to adhesion of calculi or calcification, the method comprising: a step of reacting for 1 to 5 days in a reaction solution of pH 8.3 to 10 containing dopamine and/or a derivative thereof at a concentration of 5 to 16 mM (Deposition of pDA on Substrates section, p. 1643; polydopamine layer coated by a reaction of dopamine solution at 2 mg/mL (approximately equivalent to 13 mM) in a solution at pH 8.5 for 20-120 minutes) in which a medical device to be retained in a urinary organ or a circulatory organ is immersed (see Abstract; Introduction section, pp.1642-1643; Antimicrobial Coating and Catheter section, p. 1644; Results and Discussion section, p. 1644; Antifouling and Antimicrobial Coatings on Silicone-based Urinary Catheters section, p. 1648; Conclusion section, pp. 1648-1649; creation of a urinary catheter having a polydopamine coating is expressly disclosed), thereby forming a layer containing polydopamine and/or a derivative thereof on a surface of the medical device (see Abstract; Introduction section, pp.1642-1643; Antimicrobial Coating and Catheter section, p. 1644; Results and Discussion section, p. 1644; Antifouling and Antimicrobial Coatings on Silicone-based Urinary Catheters section, p. 1648; Conclusion section, pp. 1648-1649; creation of a urinary catheter having a polydopamine coating is expressly disclosed), wherein the method does not include a step of further providing other layer on the surface of the layer (Preparation od Dual Functional Coatings section, p. 1644; embodiments without copper adlayers are expressly disclosed).
Claim(s) 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Su et al., Strong Antibacterial Polydopamine Coatings Prepared by a Shaking-assisted Method (Scientific Reports 2016, 6:24420, pp. 1-8) (see IDS dated 8/18/2023).
Su discloses medical devices coated with polydopamine and methods of coating medical devices comprising the following claim limitations:
(claim 1) An agent for suppressing adhesion of calculi or calcification comprising polydopamine and/or a derivative thereof (see Abstract; Antibacterial activity of rPDA coatings section, pp.3-5; Preparation of the PDA coatings section, p. 6; a medical device substrate, such as a catheter, having a polydopamine coating is expressly disclosed), wherein the agent for suppressing adhesion of calculi or calcification is used to form at least an outermost surface of a coating layer of a medical device to be retained in a urinary organ or a circulatory organ (see Abstract; Antibacterial activity of rPDA coatings section, pp.3-5; Preparation of the PDA coatings section, p. 6; a medical device substrate, such as a catheter, having a polydopamine coating is expressly disclosed);
(claim 2) wherein the polydopamine and/or the derivative thereof is obtained by a reacting for 1 to 5 days in a reaction solution of pH 8.3 to 10 containing dopamine and/or a derivative thereof at a concentration of 5 to 16 mM (Preparation of the PDA coatings section, p. 6; PDA coating expressly created by a dopamine solution at 2 mg/mL (approximately equivalent to 13 mM) in a solution at pH 8.5 for 24 hours) (additionally the claim language is interpreted as a product-by-process claim as the device of Fan appear to be substantially identical to the device claimed, although produce by a potentially different process, therefore the burden is upon the applicant to come forward with evidence establishing an unobvious difference between the two; In re Marosi, 218 USPQ 289 (Fed. Cir. 1983));
(claim 3) wherein the medical device is a ureteral stent, a renal pelvis catheter, a urethral catheter, or an artificial blood vessel (see Abstract; Antibacterial activity of rPDA coatings section, pp.3-5; a medical device substrate, such as a catheter, having a polydopamine coating is expressly disclosed);
(claim 4) A medical device less susceptible to adhesion of calculi or calcification, the medical device comprising: a medical device to be retained in a urinary organ or a circulatory organ (see Abstract; Antibacterial activity of rPDA coatings section, pp.3-5; Preparation of the PDA coatings section, p. 6; a medical device substrate, such as a catheter, having a polydopamine coating is expressly disclosed); and a coating layer provided on a surface of the medical device, wherein at least an outermost surface of the coating layer is a layer containing polydopamine and/or a derivative thereof (see Abstract; Antibacterial activity of rPDA coatings section, pp.3-5; Preparation of the PDA coatings section, p. 6; a medical device substrate, such as a catheter, having a polydopamine coating is expressly disclosed); and
(claim 5) A method for manufacturing a medical device less susceptible to adhesion of calculi or calcification, the method comprising: a step of reacting for 1 to 5 days in a reaction solution of pH 8.3 to 10 containing dopamine and/or a derivative thereof at a concentration of 5 to 16 mM (Preparation of the PDA coatings section, p. 6; PDA coating expressly created by a dopamine solution at 2 mg/mL (approximately equivalent to 13 mM) in a solution at pH 8.5 for 24 hours) in which a medical device to be retained in a urinary organ or a circulatory organ is immersed, thereby forming a layer containing polydopamine and/or a derivative thereof on a surface of the medical device (see Abstract; Antibacterial activity of rPDA coatings section, pp.3-5; Preparation of the PDA coatings section, p. 6; formation on a medical device substrate, such as a catheter, having a polydopamine coating is expressly disclosed), wherein the method does not include a step of further providing other layer on the surface of the layer (see Abstract; Antibacterial activity of rPDA coatings section, pp.3-5; Preparation of the PDA coatings section, p. 6; formation on a medical device substrate, such as a catheter, having a polydopamine coating via immersion and subsequent air drying is expressly disclosed).
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