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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/19/25 has been entered.
Response to Arguments
Applicant's arguments filed 07/18/25 have been fully considered but they are not persuasive.
On pages 7-13 Applicant repeats previously presented arguments, and also argues new amendments overcome the rejections of record.
The Examiner respectfully refers to the response to arguments section mailed 05/20/25, and also refers to the rejection below regarding amended claims.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 6, 20, 22-23, 25-26, 28, 31-33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 20, and 25 are rejected for having new matter for claiming that the “entirety of a cross-sectional profile of each spacer fin, from the base encapsulated within the polymer coating to the apex, defines a triangular shape”. A “triangle” is understood by the Examiner to include three straight sides, and three vertices whose interior angles form a sum of 180 degrees. However, something with a convex apex (as the claims also require, and as the specification describes, and as the figures (see figure 5-7) show), would necessarily have sides which are not entirety straight, and would not have interior angles that sum to 180 degrees. This is accordingly considered to be new matter.
Remaining claims are rejected for depending on a claim with new matter.
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 1-3, 6, 20, 22-23, 25-26, 28, 31-33 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 pre-AIA the applicant regards as the invention.
Claims 1, 20, and 25 are indefinite for claiming that the fins form a “gradual” slope when it is unclear what the meaning of the term “gradual” is. Merriam-Webster defines the term as “moving, changing, or developing by fine or often imperceptible degrees; proceeding the steps or degrees”, but it is unclear exactly how small the step/degree must be in order for the slope to be considered “gradual”. The specification does not define (or even use) the term anywhere therein, meaning the Examiner cannot understand the boundaries of the claim.
The claims are all further indefinite for claiming that the apex of the spacer fins are “convex”, and also requiring the “entirety of a cross-sectional profile of each spacer fin, from the base encapsulated within the polymer coating to the apex, defines a triangular shape”. A “triangle” is understood by the Examiner to include three straight sides, and three vertices whose interior angles form a sum of 180 degrees. However, something with a convex apex would necessarily have sides which are not entirety straight, and would not have interior angles that sum to 180 degrees. Additionally, the figures (e.g. figures 5-7) fail to show the entirety of a cross-sectional profile of each spaced fin forming a triangular shape, as the claim requires. It is accordingly unclear how all the limitations of the claims can be met at the same time.
Remaining claims are rejected for depending on an indefinite claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 6, 20, 32-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berg et al. (US 20030018377 A1) hereinafter known as Berg in view of Firstenberg et al. (US 20130268063 A1) hereinafter known as Firstenberg.
Regarding claim 1 Berg discloses a medical stent (e.g. item 100, 200, etc.) extending from a first end to a second end comprising:
an expandable structure ([0095]) extending from the first to second end which is expandable and collapsible ([0095]) and includes an inner (5304) and outer surface (5306);
a plurality of elongate, triangular spacer fins extending radially outward of an outer surface of the expandable structure to an apex (Figures 54-56 shows the elongate base (5310) of the triangular spacer fins (item 5314) extending radially outward of the outer surface of the structure to an apex),
wherein each of the spacer fins is formed of a material different from that of the expandable structure ([0097], [0099] the stent can be made of any of the listed materials, and the fins can be made of any of the materials listed; see also [0106] the anchor is made of a less elastic material than the body),
wherein a base of the fins is elongated and encapsulated within the outer surface (Figures 54-56 shows the base 5310 and its encapsulation. See also [0106] the anchor is wholly embedded in the structure) and the apex of the fins are radially exposed outward of the outer surface (Figure 55-56),
and the fins are configured to provide migration resistance upon implantation of the stent within a body lumen (The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2144 (I). In this case, the patented apparatus of Berg discloses (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed apparatus. See, for example the Abstract, [0096], [0101] which indicate the anchor implants within a tissue and accordingly is capable of resisting migration.),
but is silent with regard to there being a polymer coating disposed over the expandable structure,
the expandable structure being metal,
and the fins continuously tapering from the base to a convex apex forming a gradual slope from the base to apex so an entire cross-sectional profile of each spacer fin from the encapsulated base to the apex, defines a triangular shape, and the apex being concave.
However, regarding claim 1 Firstenberg teaches an expandable ([0031]) medical stent (Figure 11/1) with a polymer coating (Figure 2 item 56) disposed over the metallic stent ([0045] metal stent), which includes spacer a plurality of spacer fins extending radially outward of an outer surface of the polymer coating (Figures 1-2 item 54), the spacer fins being shaped so it continuously tapers from a base to an apex forming a gradual slope from the base to the apex (Figure 5 this slope is considered to be gradual) wherein an entirety of a cross-sectional profile of each spacer fin, from the base encapsulated within the polymer to the apex, defines a triangular shape (Figure 5; [0033] pyramid shaped),
wherein each spacer fin is formed of a material different from the expandable metal structure and the polymer coating ([0045] the stent can be formed from metal; [0041] the fins 54 are made of a polymer; [0042] the base of the coating 56 and fins 54 are formed of different materials).
Further, Firstenberg teaches that the apex of their fins can be convex (Figure 6).
Berg and Firstenberg are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent of Berg so that the its stent is made of metal and included a polymer coating with fins attaching to the polymer coating as is taught by Firstenberg as opposed to the stent of Berg in order to allow the stent of Berg to have the mechanical benefits (e.g. strength) of metallic stents, as well as the biocompatibility/desired tissue growth benefits offered by a polymer coating at the same time. See Firstenberg [0004]. The Examiner notes that the person of ordinary skill, in modifying Berg in light of Firstenberg, would have likewise found it obvious to embed the anchors within the polymer coating of the Combination as opposed to within the stent itself in order to preserve the anchor’s location near the exterior surface of the device as a whole, and to enable the manufacturing methods of Berg to be maintained (Berg [0106]). Further, it would have been obvious to one of ordinary skill to have the shape of the triangular fins of Berg so they continuously taper from the base to an apex to form a triangular shape as is taught by Firstenberg, and to modify that shape so that the apex is convex as is also taught by Firstenberg, since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, any shape of fin known in the art would have been obvious to try. The Combination is understood to result in a triangular shaped fin (with a rounded apex) which tapers from the base to apex, including at the location the fin emerges from the polymer coating of the Combination.
Regarding claim 6 the Berg Firstenberg Combination teaches the stent of claim 1 substantially as is claimed,
wherein the Combination further teaches each of the fins are separately formed from the expandable metal structure and the polymer coating with each having a base which is encapsulated within the polymer coating (see Berg who teaches the fins are insert molded to be wholly embedded (encapsulated) into the expandable structure ([0106]), and see the rejection in light of Firstenberg in the rejection to claim 1 above in which the stent is modified to be metallic and the anchors extend instead from the polymer coating. The Combination results in the metallic stent (which is inherently formed separately from any different material lying thereabove) and anchors insert molded (embedded/encapsulated) into a polymer coating).
Regarding claim 20 the Berg Firstenberg Combination teaches the stent of claim 1 substantially as is claimed,
wherein Berg further taches each spacer fin has a flared base (Figures 54-56), and
wherein Firstenberg further teaches the expandable metal structure is braided ([0045] metal stent; Figure 11; [0004] braided structure of the stent). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent of the Berg Firstenberg Combination so that the metal structure is braided as is taught by Firstenberg since stents are known to come in variety of shapes, sizes, configurations, and methods of manufacture. The person of ordinary skill understands the obviousness of trying any known type of stent in the art (see MPEP 2143(I)(E)).
Regarding claim 32 the Berg Firstenberg Combination teaches the stent of claim 1 substantially as is claimed,
wherein Berg further discloses the base of each of the fins extends perpendicular to a central longitudinal axis of the expandable structure (see Figures 53-54 where base 5310 extends in the circumferential directions P/Q, perpendicular to the longitudinal axis of the structure).
Regarding claim 33 the Berg Firstenberg Combination teaches the stent of claim 20 substantially as is claimed,
wherein Berg further discloses the base of each of the fins extends perpendicular to a central longitudinal axis of the expandable structure (see Figures 53-54 where base 5310 extends in the circumferential directions P/Q, perpendicular to the longitudinal axis of the structure).
Claims 2, 22, 25-26, 30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berg and Firstenberg as is applied above, further in view of Sherry (US 20080249598 A1).
Regarding claim 2 the Berg Firstenberg Combination teaches the stent of claim 1 substantially as is claimed,
but is silent with regards to the spacer fins being formed of a biodegradable material.
However, regarding claim 2 Sherry teaches anchors for stents for resisting migration can be made of a biodegradable material ([0012]). Berg and Sherry are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent of the Berg Firstenberg Combination so that the anchor fins are degradable as is taught by Sherry in order to allow the stent enough time to anchor in place, but allow easy removal after therapeutic treatment is complete ([0014]). The Combination is understood to have the functional limitations of the fins substantially degrading after implantation while leaving the metal structure and polymer coating in place (Sherry [0014]; the anchors are degradable. Firstenberg teaches they include a metal stent ([0045]) and include non-degradable coatings ([0041]). While it is not explicitly discussed that the metal material of Firstenberg’s stent is biostable, the person of ordinary skill in the art understands that unless a material is disclosed as being biodegradable, it can be reasonable considered obvious that it will not biodegrade. Further, Firstenberg teaches their metal stent is self-expandable ([0031]) and Sherry also teaches metallic self-expanding materials are biostable ([0029]). This indicates that if not explicitly taught by Firstenberg, the anchors degrading while leaving behind the (biostable) polymer coating and (biostable) metal structure is obvious in light of Firstenberg and Sherry).
Regarding claim 22 see the rejection to claims 2 above.
Regarding claim 25 Berg discloses a medical stent (e.g. item 100, 200, etc.) extending from a first end to a second end comprising:
an expandable structure ([0095]) extending from the first to second end which is expandable and collapsible ([0095], the expandable metal structure includes an inner (5304) and outer surface (5306);
a plurality of elongate, triangular spacer fins extending radially outward of an outer surface of the expandable structure (Figures 54-56 shows the elongate base (5310) of the triangular spacer fins (item 5314) extending radially outward of the outer surface of the structure),
wherein each of the spacer fins is formed of a material different from that of the expandable structure ([0097], [0099] the stent can be made of any of the listed materials, and the fins can be made of any of the materials listed; see also [0106] the anchor is made of a less elastic material than the body),
wherein a three-dimensional base of the fins is elongated and encapsulated within the outer surface (Figures 54-56 shows the base 5310 and its encapsulation. See also [0106] the anchor is wholly embedded in the structure) and an apex of the fins are radially exposed outward of the outer surface (Figure 55-56),
and the fins are configured to provide migration resistance upon implantation of the stent within a body lumen (This is stated as a functional limitation (see the explanation above). See also, for example the Abstract, [0096], [0101] which indicate the anchor implants within a tissue and accordingly is capable of resisting migration.),
but is silent with regard to there being a polymer coating disposed over the expandable structure,
each of the fins tapers continuously from the base region to the convex apex, forming a gradual slope from the base region to the convex apex, wherein an entirety of a cross-sectional profile of each spacer fin, from the base region encapsulated within the polymer coating to the convex apex, defines a triangular shape,
the expandable structure being metal,
and the fins being biodegradable.
However, regarding claim 25 Firstenberg teaches an expandable ([0031]) medical stent (Figure 11/1) with a polymer coating (Figure 2 item 56) disposed over the metallic stent ([0045] metal stent), which includes spacer a plurality of spacer fins extending radially outward of an outer surface of the polymer coating (Figures 1-2 item 54),
wherein the polymer coating has an inner surface contacting the outer surface of the expandable metal structure and an outer surface opposite thereof (Figure 2),
wherein each spacer fin is formed of a material different from the expandable metal structure and the polymer coating ([0045] the stent can be formed from metal; [0041] the fins 54 are made of a polymer; [0042] the base of the coating 56 and fins 54 are formed of different materials),
the spacer fins being continuously tapered from a base region to an apex, forming a gradual slope, from the base to the apex (Figure 5 this slope is considered to be gradual), wherein an entirety of a cross-sectional profile of each spacer fin, from the base encapsulated within the polymer to the apex, defines a triangular shape (Figure 5; [0033] pyramid shaped),
Further, Firstenberg teaches that the apex of their fins can be convex (Figure 6).
Berg and Firstenberg are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent of Berg so that the its stent is made of metal and included a polymer coating with fins attaching to the polymer coating as is taught by Firstenberg as opposed to the stent of Berg in order to allow the stent of Berg to have the mechanical benefits (e.g. strength) of metallic stents, as well as the biocompatibility/desired tissue growth benefits offered by a polymer coating at the same time. See Firstenberg [0004]. The Examiner notes that the person of ordinary skill, in modifying Berg in light of Firstenberg, would have likewise found it obvious to embed the anchors within the polymer coating of the Combination as opposed to within the stent itself in order to preserve the anchor’s location near the exterior surface of the device as a whole, and to enable the manufacturing methods of Berg to be maintained (Berg [0106]). Further, it would have been obvious to one of ordinary skill to have the shape of the triangular fins of Berg so they continuously taper from the base to an apex to form a triangular shape as is taught by Firstenberg, and to modify that shape so that the apex is convex as is also taught by Firstenberg, since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, any shape of fin known in the art would have been obvious to try. The Combination is understood to result in a triangular shaped fin (with a rounded apex) which tapers from the base to apex, including at the location the fin emerges from the polymer coating of the Combination.
Further, regarding claim 25 Sherry teaches anchors for stents for resisting migration can be made of a biodegradable material ([0012]). Berg and Sherry are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent of the Berg Firstenberg Combination so that the anchor fins are degradable as is taught by Sherry in order to allow the stent enough time to anchor in place, but allow easy removal after therapeutic treatment is complete ([0014]). The Combination is understood to have the functional limitations of the fins substantially degrading after implantation while leaving the metal structure and polymer coating in place (Sherry [0014]; the anchors are degradable. Firstenberg teaches they include a metal stent ([0045]) and include non-degradable coatings ([0041]). While it is not explicitly discussed that the metal material of Firstenberg’s stent is biostable, the person of ordinary skill in the art understands that unless a material is disclosed as being biodegradable, it can be reasonable considered obvious that it will not biodegrade. Further, Firstenberg teaches their metal stent is self-expandable ([0031]) and Sherry also teaches metallic self-expanding materials are biostable ([0029]). This indicates that if not explicitly taught by Firstenberg, the anchors degrading while leaving behind the (biostable) polymer coating and (biostable) metal structure is obvious in light of Firstenberg and Sherry).
Regarding claim 26 the Berg Firstenberg Sherry Combination teaches the stent of claim 25 substantially as is claimed,
wherein Firstenberg further teaches the expandable metal structure is braided ([0045] metal stent; Figure 11; [0004] braided structure of the stent). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent of the Berg Firstenberg Combination so that the metal structure is braided as is taught by Firstenberg since stents are known to come in variety of shapes, sizes, configurations, and methods of manufacture. The person of ordinary skill understands the obviousness of trying any known type of stent in the art (see MPEP 2143(I)(E)).
Regarding claim 30 the Berg Firstenberg Combination teaches the stent of claim 25 substantially as is claimed,
wherein Combination further teaches each of the plurality of spacer fins tapers from the base region to the apex from a location in which the spacer fin emerges from the polymer coating (see the explanation in the rejection to claim 1, above).
Regarding claim 31 the Berg Firstenberg Combination teaches the stent of claim 25 substantially as is claimed,
wherein Berg further discloses each of the fins extends perpendicular to a central longitudinal axis of the expandable structure (see Figures 53-54 where base 5310 extends in the circumferential directions P/Q, perpendicular to the longitudinal axis of the structure).
Claim 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berg and Firstenberg as is applied above, further in view of Weber et al. (US 20120259405 A1) hereinafter known as Weber.
Regarding claim 3 the Berg Firstenberg Combination teaches the stent of claim 1 substantially as is claimed,
but is silent with regards to the spacer fins including a therapeutic agent.
However, regarding claim 3 Weber teaches stent anchors can include a therapeutic agent ([0040]). Berg and Weber are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent of the Berg Firstenberg Combination so that the fins include therapeutic agent such as is taught by Weber in order to allow the therapeutic agent contained within the fins to degrade upon implantation, thus releasing their therapeutic benefit to the patient and reduce inflammation over time.
Claims 23 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berg and Firstenberg and Sherry, further in view of Weber as is applied above.
Regarding claim 23 the Berg Firstenberg Sherry Combination teaches the stent of claim 22 substantially as is claimed,
but is silent with regards to the spacer fins including a therapeutic agent.
However, regarding claim 23 Weber teaches stent anchors can include a therapeutic agent ([0040]). Berg and Weber are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent of the Berg Firstenberg Sherry Combination so that the fins include therapeutic agent such as is taught by Weber in order to allow the therapeutic agent contained within the fins to degrade upon implantation, thus releasing their therapeutic benefit to the patient and reduce inflammation over time.
Regarding claim 28 the Berg Firstenberg Sherry Combination teaches the stent of claim 25 substantially as is claimed,
but is silent with regards to the spacer fins including a therapeutic agent.
However, regarding claim 28 Weber teaches stent anchors can include a therapeutic agent ([0040]). Berg and Weber are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent of the Berg Firstenberg Sherry Combination so that the fins include therapeutic agent such as is taught by Weber in order to allow the therapeutic agent contained within the fins to degrade upon implantation, thus releasing their therapeutic benefit to the patient and reduce inflammation over time.
Conclusion
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 12/15/25