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 .
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “drug eluting mechanism” in claims 5 and 10.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 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.
The term “small arteries” in claim 5 is a relative term which renders the claim indefinite. The term “small” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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) 1-6 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Pathak et al (USPN 6,176,871).
With regards to claim 1, Pathak discloses a biodegradable endovascular medical implant device (col 5, ln 42-60), comprising: a thermoformed tube or cylinder (col 2, ln 32-50, col 6 line 13,14) positioned in a vascular region (col 11 ln 1) of a patient, comprising: a non-porous or intentionally porous (col 6 ln 7,8), polymeric material in a flexible (col 9 ln 35) form, wherein the thermoformed tube or cylinder conforms to the geometry or anatomy of the vascular region (col 19, in 66 thru col 20 ln 29), and wherein the thermoformed tube or cylinder is effective to treat peripheral arterial disease (this statement is a statement of a desired result which does not patentably limit the claim; further as set forth in col 6 lines 1-23 the device is implantable in arteries in order to support and treat then and is thus disclosed as capable of performing the desired result; a “whereby” clause that merely states the result of the limitations in the claims adds nothing to the patentability or substance of the claim. See Texas Instruments Inc. v. International Trade Commission, 26 USPQ2d 1010 (Fed. Cir. 1993); Griffin v. Bertina, 62 USPQ2d 1431 (Fed. Cir. 2002); Amazon.com Inc. v. Barnesandnoble.com Inc., 57 USPQ2d 1747 (Fed. Cir. 2001)).
With regards to claim 2, Pathak discloses the device of claim 1 as set forth above, wherein the polymeric material comprises a polymer or blend thereof selected from the group consisting of collagen, gelatin, tropoelastin, polyesters, polyurethanes, polyurethane ureas (see col 14 ln 26-33) and, blends and combinations thereof.
With regards to claim 3, Pathak discloses the device of claim 1, wherein the flexible (col 9 ln 35) form is selected from the group consisting of a cover, sheet (col 3 ln 30), membrane, coating, and matrix.
With regards to claim 4, Pathak discloses the device of claim 1, wherein the geometry or anatomy is selected from the group consisting of small arteries and cross-joints (this statement is a statement of a desired result which does not patentably limit the claim; further as set forth in col 6 lines 1-23 the device is implantable in arteries in order to support and treat then and the device is described as flexible at col 9 ln 35, thus Pathak device is disclosed as capable of performing the desired result; it is further noted that it is the flexible nature of the device which allows it to be used in “small arteries” and “cross-joints”, see [0005]; a “whereby” clause that merely states the result of the limitations in the claims adds nothing to the patentability or substance of the claim. See Texas Instruments Inc. v. International Trade Commission, 26 USPQ2d 1010 (Fed. Cir. 1993); Griffin v. Bertina, 62 USPQ2d 1431 (Fed. Cir. 2002); Amazon.com Inc. v. Barnesandnoble.com Inc., 57 USPQ2d 1747 (Fed. Cir. 2001)).
With regards to claim 5, Pathak discloses the device of claim 1, wherein said device is effective to treat below-the-knee peripheral arterial disease (this statement is a statement of a desired result which does not patentably limit the claim; further as set forth in col 6 lines 1-23 the device is implantable in arteries in order to support and treat then and the device is described as flexible at col 9 ln 35, thus Pathak device is disclosed as capable of performing the desired result; it is further noted that it is the flexible nature of the device which allows it to be used in “small arteries” and “cross-joints”, see [0005]; a “whereby” clause that merely states the result of the limitations in the claims adds nothing to the patentability or substance of the claim. See Texas Instruments Inc. v. International Trade Commission, 26 USPQ2d 1010 (Fed. Cir. 1993); Griffin v. Bertina, 62 USPQ2d 1431 (Fed. Cir. 2002); Amazon.com Inc. v. Barnesandnoble.com Inc., 57 USPQ2d 1747 (Fed. Cir. 2001)).
With regards to claim 6, Pathak discloses the device of claim 1, wherein said device further comprises a drug eluting mechanism (see col 21 lines 4-12 which sets forth that the polymer coating may act as a drug depot).
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.
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.
Claim(s) 7-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pathak et al in view of Bar et al (USPAP 2015/0032197).
Pathak et al disclose a method of preparing a flexible, biodegradable endovascular medical implant device (col 5, ln 42-60), comprising: preparing a flexible (col 9 ln 35) material comprised of polymer or blends thereof (see col 9 ln 24-27; col 12 ln 1-14; col 20 ln 50-59), obtaining a balloon catheter (col 11 ln 34-45; col 17 ln 24-46); wrapping or rolling the flexible material around the balloon catheter with the balloon in its deflated state (col 3 ln 28-33; col 16 ln 18-26; col 23 ln 11-17); inserting the wrapped or rolled flexible material and the underlying balloon catheter in the deflated state into a target vascular region of a patient (col 11 ln 34-45; col 15 ln 36-56; col 23 ln 20-38); subsequently inflating the balloon in the target vascular region (col 11 ln 34-45; col 12 15-29; col 23 ln 20-38); and thermoforming in situ by applying heat to the flexible material to form a tube or cylinder structure (col 2 ln 18-50; col 19 ln 8-26; col 23 ln 20-38) that conforms to the geometry or anatomy of the target vascular region (col 19 ln 66 to col 20 ln 29; col 21 ln 4-23). Pathak et al do not specifically not that the flexible material is flat.
However Bar et al disclose a biodegradable endovascular medical implant device (see para [0010], [0037], [0104]) comprising a tube in a vascular region of a patient (para [0062], [0104], [0122]), wherein the material is flat (para [0010], [0104], [,0122], porous flexible material has a thickness of less than 20 microns).
At the time of the effective filing date it would have been obvious to one of ordinary skill in the art that treating the vascular region as taught by Bar et al for use in a biodegradable endovascular medical implant device as in Pathak et al would have been obvious in order to reduce the chance of embolization (Bar et al; para [0060]), because Pathak et al and Bar et al are directed towards biodegradable endovascular medical implant devices.
With regards to claim 8, Pathak et al in view of Bar et al disclose the method of claim 7, Pathak et al further disclose wherein the thermoforming step comprises: inflating the balloon (col 11, ln 34-45; col. 23; ln 20-38); increasing the temperature (col 15 ln 58 to col 16 ln 26); heating for a period of time (col 21 ln 53-67; col 23 ln 20-44); and subsequently deflating the balloon (col 23 ln 20-44; col 17 ln 24-46), wherein, during this step, the flat, flexible material wrapped or rolled around the balloon catheter that has been inflated (col 3 ln 28-33; col 16 ln 18-26; col 23 ln 11-17), first conforms to the target vascular region anatomy (col 19 ln 66 to col 20 ln 29; col 21 ln 4-23) and then after heating, forms a tube or cylinder structure (col 11 ln 34-45; col 16 ln 7-26).
With regards to claim 9, Pathak et al in view of Bar et al disclose the method of claim 8, wherein the heating step is performed one or more times with or without a cooling cycle therebetween (col 10 ln 48-63; col 16 ln 7-26).
With regards to claim 10, Pathak et al in view of Bar et al disclose the method of claim 7, Pathak et al further disclose the method comprising a drug-eluting mechanism (see col 21 lines 4-12 which sets forth that the polymer coating may act as a drug depot).
With regards to claim 11, Pathak et al in view of Bar et al disclose the method of claim 10, Pathak et al further disclose the method comprising, comprising attaching a drug directly or indirectly to a surface of the flat, flexible material (see Pathak at col 21 lines 4-12 discussing the drug depot).
With regards to claim 12, Pathak et al in view of Bar et al discloses the method of claim 10, comprising Bar et al similarly discloses encapsulating or embedding a drug (para [0139], [0176]) into the flat flexible material .
With regards to claim 13, Pathak et al in view of Bar et al discloses the method of claim 11, wherein the attaching the drug is conducted during or subsequent to preparing (para [0134], [0163]) the flat, flexible material.
With regards to claim 14, Pathak et al in view of Bar et al discloses the method of claim 12, wherein the encapsulating or embedding the drug is conducted during or subsequent to preparing (para [0184], [0224]) the flat, flexible material (para [0010], [0104], [0122]).
With regards to claim 15, Pathak et al in view of Bar et al discloses the method of claim 10, wherein Bar et al disclose comprising a drug stored in a plurality of pores (para [0164], [0224] porous structure is filled with hyaluronic acid that is drug eluting) formed in the flat, flexible material (para [0010], [0104], [0122]).
With regards to claim 16, Pathak et al in view of Bar et al discloses the method of claim 10, wherein Bar et al disclose the drug eluting mechanism provides a controlled and sustained release of one or more pharmaceutical agents (para [0043], [0139], [0198] and the discussion of release control rate).
With regards to claim 17, Pathak et al disclose a method of treating peripheral arterial disease (col 5 ln 42-50; col 10 ln 64-67), comprising: obtaining a polymer (col 14 ln 26-32; col 17 ln 1-10) or blend thereof in a flexible form (col 9 ln 24-37; col 12 ln 1-14; col 20 ln 50-59); applying the flexible form to a balloon catheter to surround or encompass the balloon catheter (col 3 ln 28-37; col 16 ln 18-26; col 23 ln 11-17); deflating the balloon (col 11 ln 34-45; col 15 ln 36-56; col 23 ln 20-38); inserting the flexible form and the underlying deflated balloon catheter into a patient (col 11 ln 34-45; col 15 ln 36-56; col 23 ln 20-38); advancing the flexible form and the underlying deflated balloon catheter into a target vascular region (col 15 ln37-56; col 18 ln 28-41); inflating the balloon (col 11 ln 34-45; col 15 ln 36-56; col 23 ln 20-38); conforming the flexible form to the geometry of the target vascular region (col 19 ln 66 to col 20 ln 29; col 21 ln 4-23); increasing the temperature (col 15 ln 58 to col 16 ln 26; col 23 ln 20-44); and molding the flexible form into a tubular or cylindrical structure that conforms to the geometry of the target vascular region (col 15 ln 50 to col 16 ln 6; col 18 ln 27-42; col 19 ln 66 to col 20 ln 29; col 21 ln 4-23), but does not specifically disclose that the artery disease is peripheral arterial disease. However Bar et al disclose a similar implant device having an implantable tube that is effective to treat peripheral arterial disease (para [0057], [0062], carotid artery…below the knee). At the time of the effective filing date of the instant application it would have been obvious that treating the vascular region as taught by Bar et al for use in a biodegradable endovascular medical implant device as in Pathak et al would have been obvious in order to reduce the chance of embolization (Bar et al; para [0060]), because Pathak et al and Bar et al are directed towards biodegradable endovascular medical implant devices.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kurosaki et al and Lye et al disclose implantable devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES G FREAY whose telephone number is (571)272-4827. The examiner can normally be reached Mon - Fri: 8:00 - 5:00.
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, Essama Omgba can be reached at (469)295-9278. 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.
/CHARLES G FREAY/ Primary Examiner, Art Unit 3746
CGF
November 5, 2025