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 .
Claims 1-8 are pending.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-6, in the reply filed on 10/17/2025 is acknowledged. The traversal on pagers 2-3 is on the ground(s) that inventions I and II are so linked as to form a single general inventive concept satisfying the criteria for unity of invention under 37 CFR 1.475.
This argument is not persuasive because unity of invention is not a factor under consideration in United States practice of restriction under 35 USC 121.
On pages 3-5, Applicant traverses the restriction further, describing the particular benefits of the instant invention and arguing that the process of use is not achievable by a materially different product.
This is not persuasive because although the instant invention may have particular benefits in certain settings, the method of use, i.e. sustained release of a drug, can be achieved by a materially different product, i.e. a transdermal plaster. Absent evidence and/or reasoned argument that the method, as claimed, could not be practiced with another materially different product, the plaster, the restriction requirement is deemed proper.
On page 5, Applicant argues that there is not a serious search burden to examine both groups because the product group inherently covers the use group.
This is not persuasive because, inter alia, there is a search and examination burden in examining both product and method claims as the method inventions require active steps not required by the product invention and there are factors under 35 USC 112(a) that apply differently to method inventions than to product inventions.
The requirement is still deemed proper and is therefore made FINAL.
Claims 7 and 8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/17/2025.
Claim Objections – Improper Dependent Claims
Claim 6 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n). Accordingly, the claim 6 not been further treated on the merits.
Claims 1-5 are under current examination.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “One” with a capital letter “O” in each of lines 4, 20, and 25. As a capital letter can indicate the beginning of a new sentence, the examiner recommends amending the claims to use a lower case “o” in each instance. See MPEP 608.01(m). 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.
Claims 1-5 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 recites “that store a liquid or active ingredients in liquid form” in lines 5-6. The current wording is considered indefinite because it is unclear whether the liquid must be present in the claimed invention or whether the claims read on implants having reservoirs capable of storing the liquid, whether or not the liquid is present.
Claim 1 recites the limitation "the entry and exit openings" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the entry opening" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the exit opening" in line 15. There is insufficient antecedent basis for this limitation in the claim.
Claim 1, lines 17-18 describe “upper” and “lower” parts of the chamber or reservoir without providing any orientation as to what these directional limitations refer to. The claim is indefinite because it requires widths applying to certain sections of the tube/funnel system without clearly identifying which section the limitations apply to.
Claim 1 recites the limitation "the diameter of the exit opening" in line 18. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the upper part of the implant" in line 20. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the entry or input for the liquid to reach the reservoir or reservoirs" in lines 21-22. There is insufficient antecedent basis for this limitation in the claim.
Claim 1, lines 20-21 indicates that entry openings depend on the number of reservoirs, without characterizing the relationship between entry openings and reservoirs. Therefore the limitation on the entry openings is unclear.
Claim 1 recites the limitation "the lower part of the implant" in line 25. There is insufficient antecedent basis for this limitation in the claim.
In claim 1, the phrase “one or more exit openings (4) on the lower part of the implant depending on the number of reservoirs as gradual and prolonged release of the liquid or active ingredient to the implant site” is indefinite because it is unclear how this phrase limits the claim. In the interest of compact prosecution, the examiner has interpreted the phrase to limit the exit openings with functional language, reading on exit openings capable of providing as gradual and prolonged release of the liquid or active ingredient to the implant site.
Claim 1, line 26 indicates that exit openings depend on the number of reservoirs, without characterizing the relationship between entry openings and reservoirs. Therefore the limitation on the entry openings is unclear.
The term “properly” in claim 1, line 30 is a relative term which renders the claim indefinite. The term “properly” 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. Therefore it is unclear under what circumstances the plug or system to seal the implant must prevent the escape of the liquid.
Each of claims 1-5 recite "A craniofacial implant” instead of "The craniofacial implant” in reference to the implant previously recited in the independent claim 1. This usage of the indefinite article "a" introduces ambiguity as to whether the claim is intended to refer to the same implant as in the independent claim or to a different implant altogether, rather the use of the indefinite article “a” suggests a new or alternative implant, which is inconsistent with the dependent claim's intended purpose of further limiting the method of the independent claim. To resolve this indefiniteness, the claim should be amended to replace "a craniofacial implant" with "the craniofacial" to clearly and unambiguously refer back to the implant recited in the independent claim.
Claim 4 recites the limitation "the thickness of the chambers or reservoirs" in line 3. There is insufficient antecedent basis for this limitation in the claim. Specifically, it is unclear whether the claim further limits the thickness of the walls as recited in instant claim 1, line 5 or the thickness of an internal or external dimension of the chamber or reservoir itself.
Claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above.
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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Ranganathan et al. (US 2018/0168811; publication date: 06/21/2018) in view of Narciso et al. (Case Reports in Surgery; Volume 2021, Article ID 5518433, 3 pages; publication date: 08/06/2021), Rea et al. (US 2008/0183281; publication date: 07/31/2008), Becker et al. (US 2020/0384188; publication date: 12/10/2020) and Gall et al. (US 2019/0167851; publication date: 06/06/2019).
With regard to claim 1, Ranganathan discloses a 3D implant for drug delivery (title, abstract). The invention solves, inter alia, the problem of post-surgical infection in orthopedic surgeries (0003 – 0010) by delivering an antibiotic drug (0066) in liquid form (0040) from the implant to the surgical site in a prolonged manner. The implant may be formed from PEEK (0017) and comprises at least one reservoir and one microchannel (i.e. tube) for storing and delivering a therapeutic agent/drug, and the drug (e.g. the antibiotic) is released at a controlled rate to a site at risk of developing a post-surgical infection to maintain a local minimum inhibitory concentration of a desired pathogen for at least up to 12 months (i.e. liquid active ingredient is stored in the reservoir and released in a gradual and prolonged manner into the implant site; 0012, 0045). The step of incorporating a reservoir geometry and/or a microtubular channel system in the CAD (“computer aided design”; abstract) to facilitate storage and delivery of suitable therapeutically active agents (0060). The reservoir may take up a substantial space inside the liner (implant) so the reservoir forms a similar shape as the liner body and may connect to multiple microchannels (0090). The elements of the prosthetic may be custom designed to fit the requirements of the patient in terms of shape and size of a bone implant (0042). In some embodiments the microchannels leading from the reservoirs to the external surface of Ranganathan’s implant (i.e. tubes) may range in diameter from 0.5 to 5.0 mm (0086). The reservoir may connect to greater than one microchannel (0085). In one example, an implant has two reservoirs, each connected to two microchannels to facilitate drug delivery (0104). Although Ranganathan does not expressly describe openings, the only purpose of the microchannel (i.e. tube) is to release the liquid drug contained within the implant into the surgical site, therefore the examiner considers Ranganathan to inherently disclose openings at the ends of the microchannels where they meet the surface of the implant and where they meet the reservoir. Ranganathan does not discuss any particular differences in the diameter of the microchannel over its length, the examiner also considers Ranganathan to disclose openings having the same range in diameter as the microchannels, i.e. 0.5 to 5.0 mm. Ranganathan discloses that by optimizing the geometry (reservoir size, reservoir shape, number of reservoirs, and microchannels) material infill, the drug delivery can be precisely controlled (0123). On page 10, Ranganathan describes methodology to optimize flow rate (which determines drug release from the reservoir) by considering the features of the device and the characteristics of the drug-containing liquid within the reservoir.
With regard to the preamble “A craniofacial implant”, the examiner considers the term “craniofacial” to limit the implant to those suitable for craniofacial applications. Ranganathan discloses that their implant can be customized for any type of bone surgery (abstract), and therefore the examiner considers Ranganathan to disclose implants that are suitable for craniofacial use. Similarly, Ranganathan discloses PEEK as a suitable polymer for forming the implants. As one would have recognized these materials as suitable for craniofacial implants, the terms “craniofacial” and “PEEK” do not patentably define the instant invention over Ranganathan (see MPEP 2144.07).
Moreover, motivation existed in the art at the time of filing to use PEEK polymers to form craniofacial implants:
Nathan discloses that craniofacial surgery is accompanied by risk of infection, that 3D printed PEEK can be used to form a craniofacial implant, and that implants formed from PEEK are less likely to result in infection (page 1, right col).
It would have been prima facie obvious to form Ranganathan’s implant from a PEEK material for craniofacial use. The skilled artisan would have had motivation to do so in order to provide several lines of defense against infection at the surgical site. The artisan of ordinary skill would have had reasonable expectation of success because Ranganathan teaches customizing the implants for patient-specific needs using CAD and 3D printing, because Ranganathan teaches a means to optimize drug release, and because Narciso teaches that 3D printed PEEK is beneficial for craniofacial implants.
As noted above, Ranganathan discloses the implant to be highly customizable and release rate to be controllable by the geometry of the implant; however, Ranganathan does not mention an ovoid shape for the reservoir/chamber and also does not disclose that the tubes have a funnel shape.
Rea, in the analogous art of implants for drug delivery with drug-containing reservoirs (title, abstract), discloses a reservoir for increasing duration of drug release that has an ovoid shape (Figures 3, 4, 6, and 7, 0033). Rea discloses that the shape of the reservoir affects flow rate. Rea also describes a relationship between release rate of a drug and the relative sizes of the interior of the reservoir and the opening. When the opening width (i.e. the “first width” in Rea’s description) is smaller than the interior (i.e. the “second width”), the drug release will be slowed (0041). The examiner considers a conduit having an opening that is narrower than the internal segment to fall within the scope of the word “funnel” recited in the instant claims.
It would have been prima facie obvious to explore the effect of ovoid shaped reservoirs and funnel shaped delivery microchannels (i.e. tubes) as variables in optimization of drug release from an implant for preventing infection in craniofacial surgery. With regard to the size of the two tubes and openings (referred to as entry and exit tubes and openings in the claims) as noted above, the examiner considers the diameter ranges of 0.5 – 5.0 mm disclosed by Ranganathan to apply to the diameter of the microchambers (tubes) as well as their openings into the reservoirs and openings out of the implant. The ranges for the diameters overlap with those recited in the instant claims. Please refer to MPEP 2144.05(II)(A): Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
With regard to the limitations of instant claims 1 and 4 regarding the thickness of the ovoid chamber/reservoir walls required by the instant claims, Ranganathan provides guidance on size and shape of the reservoir, indicates that the implant can be optimized by CAD to be any required shape for bone surgery, and provides a list of materials suitable to form the implant. Rea provides further guidance on how the size of the reservoir within the implant influences drug release kinetics. One having ordinary skill in the art, having a Ph.D. in e.g. materials science, would have understood that drug reservoir size would need to be balanced with structural integrity of the implant, and would therefore have formed walls between reservoirs of sufficient width to provide the requisite support to the structure. For this reason, the examiner does not consider the width of the walls (i.e. the PEEK material surrounding the reservoir) to patentably define over the cited prior art, absent an unexpectedly superior performance associated with this limitation.
The instant claims require a tube and an associated opening referred to as “entry” and a tube and associated opening referred to as “exit”. One is used for loading the liquid or active ingredient in liquid form (claim 1 regarding the entry tube/opening: “where said opening is the entry or input for the liquid to reach the reservoir”; and regarding the exit tube/opening: “as gradual and prolonged release to the implant site”). The only structural difference between these two sets of tubes and openings that is recited in the instant claims requires the entry opening to be blocked by a PEEK filament plug or a titanium screw, whereas the exit tube/opening is sealed with any plug or system that can prevent the escape of the liquid prior to setting the implant. The scope of the exit tube/opening covering is broader but does embrace the same materials as the covering for the entry tube/opening. As Ranganathan teaches reservoirs having greater than one tube, the examiner considers this document to render obvious both an “entry” opening/tube and an “exit” opening/tube, as at least one of the tubes disclosed by Ranganathan would be capable of receiving the liquid drug into the reservoir. Ranganathan does not disclose any blockage/plug/sealing system over the openings in the implant.
Becker, in the analogous art of devices having reservoirs and tubes for delivery of liquid active agents (title, abstract, claims 1 and 7), discloses that the reservoir for liquid drug can be loaded through a fill port (i.e. an entry tube/opening) that then can be sealed by a window that is moved over the port or by a rotatable reservoir that seals the fill (i.e. entry) port.
Gall discloses sealing pores for drug release from antibiotic drug-containing reservoirs with parafilm to prevent loss of the drug-containing composition (0022).
It would have been prima facie obvious to design the implant taught by Ranganathan to have at least one tube/opening suitable for loading the reservoir with liquid and at least one tube/opening that is suitable for optimal sustained release of the antibiotic liquid over a prescribed duration. The skilled artisan would have been motivated to do so in order to optimize antibiotic liquid loading efficiency and separately optimize the flow characteristics responsible for sustained release of the liquid. The artisan of ordinary skill, in view of the cited prior art, would have understood that the channels for releasing the drug would necessarily need to be relatively narrow for extended release and that the antibiotic liquid would necessarily need to be load into the reservoir via a tube/opening. In view of the prior art cited above, one having ordinary skill would have recognized that the antibiotic liquid could be efficiently loaded through a tube/opening sized to receive the liquid efficiently, then sealed using more of the same material that was used to form the implant (i.e. a PEEK filament as used to form the entire implant via 3D printing in Ranganathan). The artisan of ordinary skill also would have recognized that materials to prevent the premature escape of the liquid prior to setting the implant were widely available as of the instant effective filing date. For these reasons the examiner does not consider the language characterizing the entry and exit tubes/openings to patentably define over the cited prior art.
With regard to claims 2 and 3, as noted above, the range in diameter of the tubes/openings taught by Ranganathan overlaps with the diameter required by the instant claims. See MPEP 2144.05.
With regard to claim 5, Ranganathan discloses that the length of the tube, along with the radius of the tube affects flow rate (and thus drug release) from the reservoir. It would have been obvious to optimize the length of the exit and entry tubes as an element of optimizing the release characteristics of the implant. See MPEP 2144.05(II)(A), as noted above.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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/KATHERINE PEEBLES/Primary Examiner, Art Unit 1617