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Claims 5, 8, and 10-12 have been withdrawn from consideration.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 elected Species 1 (Figures 1-5) without traverse on 05/12/2025.
Drawings
The drawing objections have been withdrawn in view of the applicant’s amendments.
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 no 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 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 13 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 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 scope of the shape cannot be readily determined. For example, particles, strips, chunks, and pieces can be broadly construed to mean just about any shape. Every object is made up of particles. Strips, chunks, and pieces come in every imaginable shape and size. By including branched and unbranched elongated elements that includes just about every object that has any length to it. The applicant is advised to amend this claim to better define a list of shapes actually disclosed within their original disclosure and relevant to the claimed invention rather than going for the broadest possible claim.
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 reservoir of a storage device such as a large tray), 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 of no more than 60 minutes (As admitted by the applicant Erbe discloses an implant that is highly porous with broad pore size distribution and able to wick/soak/imbibe fluid quickly and retain them, with regards to the rate and percent of hydration this time can be widely adjusted based on multiple undefined factors such as the type of liquid, the amount of liquid in the container, the pressure in the container, the use of injection instruments within the container, etc. Any or a combination of these elements would enable the implant of Erbe to be effectively hydrated in under 60 minutes as positively defined in [0051] of the applicant’s disclosure) 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, spheres, regular polyhedrons, irregular polyhedrons, cones, and pyramids. (As seen in the side by side comparison the implant of Erbe and the applicant’s elected embodiment have the same shape which anticipates multiple options from this list such as at least a piece, chunk, strip, sliver, sheet, and unbranched elongated elements.)
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.
Response to Arguments
Applicant's arguments filed 10/08/2025 have been fully considered but they are not persuasive. With respect to the prior art the applicant’s arguments focus on 3 or 4 points.
The first contention made by the applicant is that Erbe fails to disclose the or recognize the need for a fluid distribution feature. This argument is entirely misplaced because Erbe clearly discloses the exact same fluid distribution feature as the applicant’s own invention. A side by side comparison is included below, clearly demonstrating that both Erbe and the applicant’s elected embodiment include a hollow cylinder cut in half lengthwise. Both inventions have open interior channels which act as fluid distribution features. It is unclear how the applicant can argue both that their invention has the fluid distribution feature and that the exact same structure on Erbe is not a fluid distribution feature.
PNG
media_image1.png
497
895
media_image1.png
Greyscale
The second contention made by the applicant is that because the half-moon shaped implant of Erbe is intended to be used on a long bone it is not sized and shaped to be disposed within a reservoir of a handling or storage device. It is unclear what the basis is for this argument. Is the applicant contending that there are no storage devices for long narrow implants with curved inner surfaces? Handling and storage devices come in all shapes and sizes. Coffins and body bags are designed to be liquid tight and contain the entire skeleton of the largest patients. There is inherently numerous medical implant storage devices or general use storage devices that the implant of Erbe is capable of fitting in.
The third contention made by the applicant is that the larger size of the implant of Erbe should not be hydrated. The applicant has provided no factual evidence of a teaching away by Erbe that his implant should not be hydrated. Furthermore the applicant has cited Erbe’s disclosure that the implant is highly porous with broad pore size distribution and able to wick/soak/imbibe fluid quickly and retain them multiple times. Finally, the hydrating steps are intended use and or intended methods of making the device, which Erbe’s invention is clearly capable of performing.
The fourth contention made by the applicant is that there is no motivation to resize or shrink down the implant of Erbe to retain a longitudinal groove or add a longitudinal groove. This argument is misplaced because there is neither a requirement within the claims to perform this step nor any indication in the office action that it should be done. Erbe discloses his implant as shown above with the longitudinal groove already present and that the porosity of the entire implant provides wicking and hydration.
With respect to the prior art combination the applicant does not present any new arguments.
Therefore the longitudinal groove already present in Erbe will act as a liquid pathway, in the same manner as the applicant’s invention, to supply the liquid to the pores of the implant. This configuration is fully capable of being used in combination with an appropriately sized container to achieve effective hydration within about 60 minutes depending on the configuration of the container.
Conclusion
THIS ACTION IS MADE FINAL. 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 CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774
Prosecution Insights