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 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.
Claim 30 is 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.
In claim 30, Applicant requires the thin fin “resembles the tail fin of an airplane”. “Resembles” is considered exemplary claim language as per MPEP 2173.05(d) as it is unclear what the intended scope of the claim would entail.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 5-7, 9, 11, 14, 15, 22 and 24 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Michal et al (US 2019/0358439).
Regarding claim 1, Michal discloses an implant comprising: an elongated body (figs 15 and 16) sized and configured for implantation into nasal tissue and being made of a biocompatible and bioabsorbable material (¶13, ¶41), the body having a distal end 1520/1620 and a proximal end 1522/1622, the distal end including a pointed tip that is configured to pierce and cut through the nasal tissue (¶105) and the proximal end including a cavity sized and shaped to receive the pointed tip of a similarly shaped implant so as to enable linear nesting of multiple implants (as pointed end tapers to a point, it shaped to fit partially within the cavity in the proximal end); and a therapeutic substance comprised by the elongated body that is released by the implant into the nasal tissue over time (¶16, ¶41, ¶44).
Regarding claim 3, wherein the pointed tip is conical (figs 15 and 16).
Regarding claim 5, wherein the elongated body is solid and the therapeutic substance is impregnated within material from which the elongated body is made (¶45, ¶55, ¶105, ¶108; as per ¶105 and 108, the embodiments in figs 15 and 16, other than shape, are “substantially similar or identical” to the other embodiments).
Regarding claim 6, wherein the elongated body includes an internal compartment in which the therapeutic substance is contained (¶63, ¶105, ¶108; as per ¶105 and 108, the embodiments in figs 15 and 16, other than shape, are “substantially similar or identical” to the other embodiments).
Regarding claim 7, wherein the elongated body further includes an aperture 528 that extends to the internal compartment through which the therapeutic substance is released (fig 5, ¶71; as per ¶105 and 108, the embodiments in figs 15 and 16, other than shape, are “substantially similar or identical” to the other embodiments).
Regarding claim 9, wherein the therapeutic substance is a corticosteroid (¶41).
Regarding claim 11, further comprising an anchoring element (flange on proximal end in fig 16) extending outward from the elongated body configured to prevent migration of the implant within the nasal tissue (due to enlarged size).
Regarding claim 14, wherein the anchoring element comprises a thin fin (fig 16).
Regarding claim 15, further comprising a retrieval tab that extends proximally from the proximal end of the elongated body configured to enable removal of the implant from the nasal tissue (fig 16, enlarged proximal end can be used as said claimed retrieval tab)
Regarding claim 22, wherein the elongated body is approximately 3 to 40 millimeters long and has a cross-sectional dimension of approximately 0.5 to 10 millimeters (¶47).
Regarding claim 24, wherein the elongated body is sized and configured for implantation into a nasal polyp or a swollen turbinate (¶41).
Claim Rejections - 35 USC § 103
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.
Claim(s) 8, 25 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michal et al (US 2019/0358439).
Regarding claim 8, while Michal substantially discloses the invention as claimed, it does not disclose the aperture comprises an elongated slit.
Michal discloses the dimensions of the aperture are a known variable to change the release rate (¶72).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Michal such that the aperture comprises an elongated slit as suggested by Michal itself to achieve a desired delivery rate.
Regarding claim 25, Michal discloses an implant comprising: an elongated body having an exterior surface (figs 15 and 16), a distal end 1520/1620, and a proximal end 1522/1622, the body being sized and configured for implantation into nasal tissue and being made of a biocompatible and bioabsorbable material (¶13, ¶41), the body further having an internal compartment configured to contain a therapeutic substance to be administered to the nasal tissue (fig 6, ¶63, as per ¶105 and 108, the embodiments in figs 15 and 16, other than shape, are “substantially similar or identical” to the other embodiments) and an opening 528 that extends from the internal compartment to the exterior surface of the body (¶71); and a therapeutic substance provided within the internal compartment of the elongated body that is released by the implant into the nasal tissue over time via the opening (¶71).
While Michal substantially discloses the invention as claimed, it does not disclose the opening is an elongated slit.
Michal discloses the dimensions of the aperture are a known variable to change the release rate (¶72).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Michal such that the opening is an elongated slit as suggested by Michal itself to achieve a desired delivery rate.
Regarding claim 26, wherein the internal compartment is elongated (fig 5, due to shape of implant).
While Michal substantially discloses the invention as claimed, it does not disclose the elongated slit extends along a length of the compartment.
As shown in fig 5, the openings extend along the length of the compartment.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to place the elongated slit along the length of the compartment as suggested by Michal itself as part of achieving a desired delivery profile while maintaining structural integrity.
Claim(s) 12 and 27-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michal et al (US 2019/0358439) in view of McKay (US 2007/0243228).
Regarding claim 12, while Michal substantially discloses the invention as claimed, it does not disclose a swept-back, pointed barb having a sharp tip that faces towards the proximal end of the body.
While fig 20 of Michal discloses a swept-back, pointed barb having a sharp tip that faces toward the proximal end of the body, it is unclear how the barb would be incorporated in figs 15 and 16.
McKay discloses an implant with a swept-back, pointed barb 12 having a sharp tip that faces towards the proximal end of the body (fig 2) which serve as an anchoring system (¶163).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Michal such that it includes a swept-back, pointed barb having a sharp tip that faces towards the proximal end of the body as taught by McKay to assist in anchoring the implant.
Regarding claims 27-29, Michal discloses an implant comprising: an elongated body (figs 15 and 16) sized and configured for implantation into nasal tissue and being made of a biocompatible and bioabsorbable material (¶13, ¶41), the body having a distal end and a proximal end, the distal end including a pointed tip 1558/1658 that is configured to pierce and cut through the nasal tissue (¶105); and a therapeutic substance comprised by the elongated body that is released by the implant into the nasal tissue over time (¶16, ¶41, ¶44).
While Michal substantially discloses the invention as claimed, it does not disclose an anchoring element that extends radially outward from the elongated body at a position near the pointed tip at the distal end of the body.
McKay discloses an implant with a swept-back, pointed barb 12 having a sharp tip that faces towards the proximal end of the body (fig 2) which serve as an anchoring system (¶163). Said anchoring element is positioned immediately proximal of the pointed tip (fig 2) and is configured as a swept-back, pointed barb (fig 2).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Michal such that it comprises an anchoring element that extends radially outward from the elongated body at a position near the pointed tip at the distal end of the body, which is positioned immediately proximal of the pointed tip and is configured as a swept-back, pointed barb as taught by McKay to assist in anchoring the device.
Regarding claim 30, wherein the anchoring element is configured as a thin fin that resembles the tail fin of an airplane (see combination above and fig 2 of McKay).
Response to Arguments
Most of Applicant's arguments are not persuasive. The examiner agrees the art does not teach the newly claimed subject matter of claim 4.
Applicant argues Michal in figs 15-20 discloses a recess sized to receive a rod-like element, not the pointed tip of a similarly shaped implant. The examiner disagrees, the pointed end tapers to a point, said point is capable of being received in the recess and thus meets the claim. Claim 4 claims more detail on how the cavity (and its shape) interact with the pointed tip of another implant and are indicated allowable.
Applicant argues barb 2074 is not a “thin fin” as required by claim 14. The examiner disagrees, words are given their broadest reasonable interpretation. While it certainly must be “thin” as claimed, it does not claim a degree of thinness either in absolute terms or with reference to another structure. Said fin is thinner than the body of the device. It also tapers to a point and thus can be considered thin. Applicant also argues it is required that have a flattened shape. The examiner disagrees, while it is unclear if the fin of Michal is flattened, the examiner does not find flatness to be a requirement. It is considered to be a fin because it is anchored at only one end and extends in a diagonal direction from the main body, similar to a fin on a fish.
With respect to claim 8, Applicant argues Michal does not suggest modifying the circular apertures to comprise elongated slits and one would instead change the diameters of the aperture. The examiner disagrees, references are not read in a vacuum but for what they teach one of ordinary skill in the art. As Michal suggests quantity and size of apertures are one way to affect release rate. But one of ordinary skill in the art is also aware shape affects delivery rate (for example see Lee et al, US 2016/0199544, ¶50). Even without Lee, one of ordinary skill in the art reading Michal would recognize that the desire via ¶72 of increasing the quantity and/or size of the apertures is decreasing the amount of sidewall and increasing the area through which a drug may pass through the sidewall; which would suggest to one of ordinary skill in the art to elongate said openings as another means by which change the area through which the drug may pass through the sidewall.
The argument against claim 25 is seen as similar to this against claim 8. See the response above.
While new language introduced in claim 27 overcomes the prior art, but new reference McKay is introduced to teach the missing limitations.
Allowable Subject Matter
Claim 4 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The examiner did not find a teaching or suggestion for modifying Michal such that the cavity comprises a conical cavity that defines a conical space such that surfaces of the pointed tip of the similarly shaped implant contact surfaces of the conical cavity when the two implants are nested with each other, absent impermissible hindsight.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
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