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 .
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 1-4 and 6-19, drawn to a device comprising a bioresorbable polymer.
Group II, claim 46, drawn to a method of making the device of claim 1 comprising making the device using additive manufacturing.
Group III, claim 51, drawn to a method of treating a subject in need thereof comprising implanting the device of claim 1 into the subject.
The three groups lack unity of invention because even though the inventions of these groups require the technical feature of a device comprising a bioresorbable polymer, wherein the device is configured to be inserted into an anatomical location of a subject at which point becomes encapsulated by vascular tissue and the bioresorbable polymer is resorbed over an amount of time thereby forming a chamber in place of the bioresorbable polymer, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Corbitt et al. (US 6,214,045; of record). Corbitt teaches a breast implant formed entirely of a bioresorbable material and is sized and shaped to replace excised tissue [Abstract]. Upon implantation, the implant allows for in-growth of fibrous tissue to replace the implant [Abstract].
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
ELECTION OF SPECIES
Claim(s) 1-4, 6-19, 46 and 51 are generic to the following disclosed patentably distinct species: PEGDA, PEGDMA, PEGDAAm, GelMA, collagen methacrylate, silk methacrylate, hyaluronic acid methacrylate, chondroitin sulfate methacrylate, elastin methacrylate, cellulose acrylate, dextran methacrylate, heparin methacrylate, NIPAAm methacrylate, Chitosan methacrylate, polyethylene glycol norbornene, polyethylene glycol dithiol, thiolated gelatin, thiolated chitosan, thiolated silk, PEG based peptide conjugates, cell-adhesive poly(ethylene glycol), MMP-sensitive poly(ethylene glycol), PEGylated fibrinogen, or a combination thereof (see p. 15 of the originally filed specification). The species are independent or distinct because the different compounds are structurally and likely functionally distinct and further capable of separate utility. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
(a) the inventions have acquired a separate status in the art in view of their different classification;
(b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and
(c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species or a grouping of patentably indistinct species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the species to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Rachel Near on 7/23/26 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-4 and 6-19 and a polycaprolactone bioresorbable polymer species. Affirmation of this election must be made by applicant in replying to this Office action. Claims 46 and 51 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Therefore, instant claims 1-4 and 6-19 and polycaprolactone bioresorbable polymer species are under current examination.
Claim Objections
Claim 13 is objected to because of the following informalities: the claim recites “…such that the first plurality of channels are further configured be at least partially filled…” in lines 3-4. The Examiner suggests adding the word “to” after “configured”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 4, 6-10 and 19 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 4 recites the limitation "the compartment" in line 1 and claims 4 and 6 recite the limitation “the second plurality of cells” in line 2. There is insufficient antecedent basis for this limitation in the claim. Claims 4 and 6 depends from claim 1, but this claim does not contain a “compartment” or a “second plurality of cells” limitation. Therefore, it is unclear what this limitation refers to and how to interpret the claim. The Examiner suggests amending the dependency of claim 4 to depend from claim 2 in order to obviate the instant rejection.
Claims 7-10 and 19 are unclear as claim 7 recites the limitation "each channel" in line 9. There is insufficient antecedent basis for this limitation in the claim. Previous in claim 7, it recites “a plurality of channels” in line 7 which encompasses multiple anti-caking and suspending agent, (emphasis added). Thus, it is unclear whether just one, more than one, or all of the anti-caking and suspending agents are being referenced and must be silicified microcrystalline cellulose. Amending claim 2 to recite “wherein the at least one anti-caking and suspending agent is…”, would overcome this rejection.
Claim 11 recites the limitations "the plurality of channels", “the first population of channels” and “the second population of channels” in line 2. There is insufficient antecedent basis for this limitation in the claim. Claims 11 depends from claim 1, but this claim does not contain such limitations. Therefore, it is unclear what this limitation refers to and how to interpret the claim.
Claim 16 recites the limitation "the amount of time" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 16 depends from claims 12 and 14, but this claim does not contain such limitation. Therefore, it is unclear what this limitation refers to and how to interpret the claim.
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 indefinite concerns outlined above.
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)(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 1-4 and 6-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cchaya et al. (US 2021/0267742; published: 9/2/21; in IDS dated 5/6/25).
Cchaya is directed to 3D printed implant with internal channels for insertion into a patient [Abstract and Title].
With regards to instant claims 1, 7, 9 and 12, Cchaya teaches an implant for insertion into a patient, wherein the implant comprises a 3D printed structure of layers and a plurality of hollow channels comprising walls [See claim 1]. Cchaya teaches that the implant is printed from a biodegradable material such as PCL [0014]. Polycaprolactone (PCL; elected species) is advantageous because it is widely used in the medical field and thus already approved by the regulatory body and meets the degradation requirement such that once it starts degrading, new tissue/vasculature can grow and settle inside the implant [0007, 0014, Figures; e.g., Fig. 2 shows the hollow channel]. Examiner’s note: the instant specification does not define “plug” and port” that is recited in instant claims 7 and 12 and therefore, the teaching of “implant” and “new tissue/vasculature” reads on such limitations. It also noted, the intended use of a claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art (See MPEP 2111.01(II)). As “port” means an opening, the implant containing hollow channels of Cchaya reads on such structural feature.
With regards to instant claims 2, 11 and 13, Cchaya teaches that after the insertion of the implant, fat cell injection into the channels which are natively formed in the implant [0013].
With regards to instant claims 3-4, Cchaya teaches that only fat or fat cells/tissue will be referred to as a representative and highly relevant form of biological material which can be used for injection into the implant; however, it should be understood that any other type of cells or biological material may be injected in the implant [0012].
With regards to instant claim 6, adipose tissue is commonly known as body fat, which is taught by Cchaya.
With regards to “solid” conduit limitations of instant claims 8, 10 and 14, Cchaya teaches wherein the implant comprises a set of infill lines (see Fig. 13B-C, structure 102). It is noted that the Examiner is interpreting a solid conduit as any solid line. The general definition of a conduit would require a conduit to be hollow; that is, the shape of a conduit could be a tube or pipe or type of cylinder, but as recited in the claims, this second plurality of conduits must be solid and therefore, the broadest reasonable interpretation would include a line of any thickness.
With regards to the “perfusable” limitations of instant claims 1, 7, 12 and 14, Cchaya teaches wherein the implant/device is made of the same material (PCL) as the instant invention and therefore the compound's properties are necessarily present; the Examiner directs attention to MPEP 2112.01(II) which states: “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present”.
With regards to instant claim 15, Cchaya teaches that the entire implant is made of the same polymer, therefore the abovementioned infill lines are made of biodegradable material such as PCL; i.e., the same bioresorbable polymer as the hollow conduits [0014].
With regards to instant claim 16, Cchaya does not teach the comparative amount of time that the hollow and solid conduits are resorbed. However, since claim 16 encompasses all possible options (both the same amount of time or any different amount of time), Cchaya reads on such limitations.
With regards to instant claim 17, Cchaya teaches wherein the oriented pores/channels of the implant facilitate the fat injection procedure for the surgeon [see Fig. 4 and channels 21]. Although Cchaya is silent with regards to the fat injections being the same or different, claim 17 encompasses all possible options (i.e., same or different) and therefore, Cchaya reads on such limitations.
With regards to instant claims 18-19, Cchaya teaches that at least one hollow channel is oriented in a direction which is tilted with respect to a reference axis perpendicular to the first outer surface of the implant [0015 and Figures, Fig. 13].
Therefore, by teaching all the limitations of claims 1-4 and 6-19, Cchaya anticipates the instant invention as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GENEVIEVE S ALLEY whose telephone number is (571)270-1111. The examiner can normally be reached Monday-Friday 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, David Blanchard can be reached at 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GENEVIEVE S ALLEY/Primary Examiner, Art Unit 1617
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