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 .
Priority
This application claims priority from provisional application 63/188,245, filed 05/13/2021.
Status of Claims
Claims 1-20 are pending.
Claims 5, 8, and 10-12 have been withdrawn from consideration.
Election/Restrictions
Applicant’s election without traverse Species 1 (Figures 1-5) in the reply filed on 05/12/2025 is acknowledged. Upon further review claims 5, 8, and 10-12 have been withdrawn as being directed at non-elected species. Specifically, these claims define the implant as a cylinder, a plurality of notches, beads, and tapered ends, but the elected embodiment is a moon shaped half cylinder.
Information Disclosure Statement
The Information Disclosure Statement filed on 05/12/2025 has been considered by the examiner. It is noted that many of the cited references have nothing to do with the patentability of the current application. Specifically cited US Patent 1,001,311 is directed at street indicators.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the tissue implant comprising all of the claimed features of claim 4 (see objection to claim 4 below) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. § 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that § 112(f) (pre-AIA § 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. § 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that § 112(f) (pre-AIA § 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke § 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke § 112(f) except as otherwise indicated in an Office action.
In this application the “one or more liquid dispersion features” are quickly defined as the pathways for the liquid. Additionally as shown in Figures 1A-D the elected embodiment has a single feature the rounded channel. There are not other structural equivalents to a channel; to anticipate the features a prior art reference needs some sort of channel. Therefore the features are not being treated in accordance with 35 U.S.C. § 112(f).
Claim Objections
Claims 1-20 are objected to for inconsistent spacing. It appears the claims are sometimes in justified format and sometimes align left. Additionally there appears to be a space missing in the preambles between of and claim. The applicant is requested to review the claims and amend their formatting to be consistent.
Claim 4 is objected to for a minor typo. The last 2 lines should say “or” in place of “and”. In its current form the claim requires the features to include all of the list not 1 or a combination of them.
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 1-20 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 is rendered indefinite by the requirement for effective hydration in line 3 and reasonable period of hydration in line 4
Claim 13 is an improper dependent claim because it fails to further limit the claim from which it depends. Claim 13 appears to be attempting to claim a variety of shapes, but several of the listed options are so broad that the inherently encompass every shape possible. For example, there is no manufactured object in the word that does not qualify as a three-dimensional geometric shape. Additionally, every manufactured object inherently is a three-dimensional form with one or more planar or curved surfaces. The applicant is advised to amend this claim to better define a list of shapes disclosed within their original disclosure and relevant to the claimed invention.
Claim 20 lacks antecedent basis for the phrase the elongated configuration in line 3. The applicant is advised to amend line 3 to say “an elongated configuration”.
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) 1-4, 6, 7, 9, and 13-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Erbe et al US 2005/0169956 A1.
It is noted that claims 1-17 are directed at just the implant and not the storage device, so claim recitations directed at how it is used or packaged within the handling/storage devices are given limited weight. Additionally recitations directed at the loading of the reservoir, dispersion of liquid, and other method steps are considered to be intended use limitations and given limited weight.
1. Erbe discloses a tissue derived implant 272 (Figure 7A)(collagen is tissue derived base for the implant [0036]) having a configuration which is sized and shaped to be disposed within a reservoir of a handling or storage device (every implant is capable of being placed in a storage device), the implant comprising one or more liquid dispersion features (inner channel Figure 7A) for enabling effective hydration of the tissue derived implant within a reasonable period of hydration time when the implant is disposed in the reservoir and is contacted with a biocompatible liquid [0103], wherein the one or more liquid dispersion features form one or more liquid pathways (inner channel Figure 7A) which facilitate collecting and distributing the biocompatible liquid to contact substantially the entire tissue derived implant (inner channel can act as a pathway to collect and distribute liquids Figure 7A).
2. Erbe discloses the one or more liquid pathways are in fluid communication, or otherwise interconnected, with one another (Figure 7A shows the same pathway as the applicant’s elected embodiment that will act in the same manner).
3. Erbe discloses the one or more liquid dispersion features cooperate with an inner surface of the reservoir to form the one or more liquid pathways while the implant is disposed in the reservoir of the handling or storage device (As explained above, this is considered to be intended use limitation and given limited weight, Figure 7A shows the same pathway as the applicant’s elected embodiment, that will act in the same manner).
4. Erbe discloses the one or more one or more liquid dispersion features comprise: a channel, a groove, a notch, a recess, a passage, a lumen, an augmented section, a contracted segment, a recessed segment, a tapered section, a gap, and combinations thereof (Figure 7A shows the same feature as the applicant’s elected embodiment, a halfmoon shaped feature that anticipates all of these terms).
6. Erbe discloses the implant has an elongated configuration comprising a strip and the one or more liquid dispersion features comprise a semi-annular cross- section of the strip, a halfmoon cross-section of the strip, or crescent moon cross-section of the strip (Figure 7A shows the same feature as the applicant’s elected embodiment, a halfmoon shaped feature that anticipates all of these terms), and when disposed within the reservoir of the storage of handling device, the implant occupies a portion of the reservoir leaving an unoccupied portion which forms the one or more liquid pathways (As explained above, this is considered to be intended use/ product by process limitations and given limited weight, Figure 7A shows the same pathway as the applicant’s elected embodiment, that will act in the same manner).
7. Erbe discloses the implant has an elongated configuration comprising a strip having an exterior surface extending a longitudinal distance between opposite first and second ends of the strip, and the one or more liquid dispersion features comprise at least one groove or channel in the exterior surface, each of which extends, independently, at least part of the longitudinal distance. (Figure 7A shows the elongated strip 272 with the same feature as the applicant’s elected embodiment, a halfmoon shaped feature).
9. Erbe discloses the implant has an elongated configuration comprising a strip or rope and the one or more liquid dispersion features comprise one or more augmented segments, one or more recessed segments, or a combination thereof (Figure 7A shows the same feature as the applicant’s elected embodiment, a halfmoon shaped feature that anticipates all of these terms).
13. Erbe discloses the implant comprises one or more shapes selected from: particles, strips, chunks, pieces, blocks, sheets, slivers, ribbons, unbranched elongated elements, branched elongated elements, filaments, fibers, three dimensional geometric shapes, symmetric shapes, asymmetric shapes, spheres, regular polyhedrons, irregular polyhedrons, cones, pyramids, three dimensional forms having one or more planar or curved surfaces, and irregular three dimensional forms. (As explained above every implant ever made comprises a shape covered by this list)
14. Erbe discloses the implant comprises one or more tissue derived matrices each having a first form comprising one or more of: particulates, fibers, chunks and pieces, and being reshaped into a second form comprising one or more: sheets, blocks, cylinders, plugs, and other three-dimensional shapes ([0036] [0058] Erbe discloses collagen pieces are manipulated in a slurry and molded to form the final shape shown in Figure 7A).
15. Erbe discloses the implant comprises one or more tissue derived matrices, at least one of which is lyophilized or cryopreserved.
16. Erbe discloses the implant is at least partially dried [0096].
17. Erbe discloses one or more additional components selected from: biocompatible fluids, preservation agents, glycerol, glycols, polyols, trehalose, polyphenols, carriers, preservatives; antibiotics, and other biocompatible substances; exogenous cells, viruses, growth factors, proteins, and other biologically active substances; antioxidants; pharmaceutically active compounds; nutritional substances or media; rheology modifiers; crosslinking agents; pH modifiers; polymers; and biologically inert excipients (Erbe discloses the polymer collagen [0036], cell seeding and drug delivery [0044]).
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.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Erbe in view of Henniges et al (Henniges) US 2008/0009792 A1.
Erbe discloses the invention substantially as claimed being described above. However, Erbe does not disclose the use of a storage container or tube for containing the implant.
Henniges teaches the use of kit comprising a sealed tray or package [0112] (Figures 22-23) for holding a reservoir/tube which contains an implant therein (Figures 12A-I show the tube containing a variety of implants) in the same field of endeavor for the purpose of providing the user with a sterile package containing all the tools needed to deliver the implant.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the sterile packaging and delivery device of Henniges with the implant of Erbe in order to provide the user with a sterile package containing all the tools needed to deliver the implant and the implant in one place.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774