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 63/225,489, which was filed on 07/24/2021. It is noted that the elected embodiments are not supported by this provisional application. Therefore, the earliest priority date for this application is its filing date of 07/20/2022.
Status of Claims
Claims 1 and 21-39 are pending.
Claims 2-20 have been cancelled.
Election/Restrictions
Applicant elected Invention I (Implantation System) with traverse on 07/16/2025 and Species 2 (Figures 2-38) without traverse during the phone call on 10/05/2025.
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. In view of the extensive new matter issues within the new claims, the drawings are objected to for not disclosing numerous new claim limitations. At least a frame and a dome joined along complementary inner surfaces, the sealed first container further comprises an outlet opening at the second side and a peelable or frangible sterile membrane covering the outlet opening prior to engagement with the funnel, a minimum diameter sized to accommodate a largest cross-sectional dimension of the implant, and the lumens/paths maintained by the engagement of the funnel to the first container 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.
Specification
The specification objection has been withdrawn in view of the applicant’s amendments.
Claim Objections
Claim 25 should recite extend into a tapered geometry in line 3.
Claim 33 is objected to because it is barely further limiting claim 30 from which it depends. Claim 30 recites the internal surfaces of the tapered passage are lubricated with a biocompatible lubricant, which is saying the same thing as claim 33 wherein the internal surfaces of the tapered passage of the funnel are coated with a biocompatible lubricant. Lubricating a surface with lubricant is all but saying that the surface is coated. The applicant is advised to amend claim 33 to further define the coating with language saying something to the order of fully coating or completely coating.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 21-39 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 30 contain new matter in the requirement for “a frame and a dome joined along complementary inner surfaces”. The connection between these two components is shown in Figures 10-11 and their connection is not made on inner surfaces. At best the joining surface of the frame 202 could be considered inward of the outer edge, but the joining surface of the dome 203 is an upper outer surface. [0081] addresses the connection in the original disclosure, but fails to define the inner surfaces. The applicant is advised to amend the claims to more accurately define the surfaces as opposing upper facing and lower facing surfaces.
Claim 23 further addresses the inner surfaces, so it is considered to include new matter and will need to be addressed in the same manner as claims 1 and 30.
Claims 22 and 30 contain the following new matter “frangible”. The original disclosure describes the cover as being peeled but never mentions the term frangible. The applicant is advised to delete the term frangible.
Claim 22 is considered to include new matter because of the requirement for “the sealed first container further comprises an outlet opening at the second side and a peelable or frangible sterile membrane covering the outlet opening prior to engagement with the funnel”. The applicant appears to be describing cover 206, but this cover extends over the funnel and is applied after engaging the funnel with the first container. The applicant is advised to delete the entire phrase “prior to engagement with the funnel”.
Claims 24, 30, and 34 are considered to include new matter because of the requirement for “a minimum diameter sized to accommodate a largest cross-sectional dimension of the implant.” As clearly seen in Figure 35, the taper has a minim diameter that is not sized to accommodate the largest cross-sectional dimension of the implant. The minimum diameter of the tapered surface is at the bottom of the funnel and it clearly cannot accommodate the largest cross-sectional dimension of the implant, which is the diameter at the flat end of the implant. Figure 35 clearly shows the implant rotates and compressed.
Claim 30 contains new matter because of the recitations requiring the funnel to peel or rupture the sterile membrane and establish a continuous sterile lumen. There are no recitations of rupture within the original disclosure. Additionally, the covers are on top of the funnel, which is not described as having any structure or ability to extend out through the cover. The original disclosure always discloses the covers being peeled as a separate step not being cause by engagement with the funnel.
Claim 31 contains new matter because the term ruptured is not supported by the original disclosure. Additionally, there is no support for the cover to be removed when the funnel is engaged with the container. This recitation implies that it is removable at the time of the connection which is not possible because for them to be engaged the cover must not have been applied yet or must already have been removed. The applicant is advised to replace “when” with “while” so that the cover can be removed after the engagement has already been achieved.
Claim 34 contains new matter because of the requirement for the engagement between the funnel and the sealed container to maintain a continuous sterile lumen between the cavity and an internal passage of the funnel. As previously explained above, the connection has no impact on the configuration of the funnel. The funnel can be folded and collapsed regardless of the connection, which eliminates the lumen. Therefore, the engagement between these components is not supported within the original disclosure as maintaining this lumen.
Claim 34 also contains new matter because of the requirement for the sealed first container and the sterile funnel together define a closed, sterile transfer path that maintains sterility of the implant from the sterile cavity through the internal passage of the sterile funnel until the implant is removed from the distal end. This is considered new matter for the same reason as explained directly above. There does not appear to be any path when the first container is sealed.
Claim 39 contains new matter because of the recitation that the “flexible wall structure configured to remain folded within the sterile cavity prior to engagement with the first container and to extend into its tapered geometry when unfolded for implantation”. The original disclosure does not support the folded funnel ever being in the cavity. As seen in Figures 5-6 , 19-21, and 29-31 the funnel is above the cavity. Additionally, even if one were to say that the position above the cavity is within the cavity there is no support for the funnel ever being anywhere near the cavity without being connected to the first container. All of the figures clearly show the connection to the container during the positioning step.
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 and 21-39 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.
Claims 1 and 30 are rendered indefinite by requiring the complimentary inner surfaces of the frame and dome to define the cavity. It is unclear how a surfaces that form the ring around the opening can define the cavity below it. They could at best define the opening to the cavity. It is the inner surface of the done that actually defines the cavity.
Claims 1, 24, 25, and 28, are all rendered indefinite for antecedent basis issues. The independent claims define the funnel as just a funnel, but each of these claims refer back to this structure as a sterile funnel. The applicant is advised to amend all recitations of funnel including the first introduction to recite sterile funnel.
Claim 21 is rendered indefinite for antecedent basis issues. Specifically claim 21 introduces a frame and a dome, but they have already been defined in the independent claim. It is unclear if the applicant is introducing new components or referring back to the original components. The applicant is advised to amend claim 21 to recite: wherein the frame and dome of the first container are circumferentially sealed along the surfaces to define the sterile cavity.
Claim 23 is rendered indefinite by requiring the continuous inner surface to define the cavity. It is unclear how a ring around the opening can define a cavity. They could at best define the opening to the cavity. It is the inner surface of the done that actually defines the cavity.
Claim 26 is rendered indefinite because it is unclear how the engagement actually produces the interface that maintains a continuous sterile lumen. As seen in Figures 18-20 the funnel is folded or collapsed leaving no continuous lumen therein. It’s unclear how any lumen is maintained when they are connected. At best there is a lumen within the lower cavity, but this is not produced by the interface with the funnel.
Claim 27 lacks antecedent basis for “the internal surfaces of the sterile cavity” and “the internal passage”, which renders it indefinite. The applicant is advised to amend the claim to recite: wherein internal surfaces of the sterile cavity and an internal passage of the funnel”.
Claim 28 is rendered indefinite because it is describing the second end of the funnel with a different name than previously defined. There only appears to be two ends to the funnel, so defining a distal end is adding another end to the funnel. The applicant is advised to amend claim 28 to recite: wherein the second end of the funnel includes.
Claim 30, lacks antecedent basis for “the internal surfaces” which renders it indefinite. The applicant is advised to amend the claim to recite: wherein internal surfaces of the tapered passage”.
Claims 30 and 32 are rendered indefinite because it is unclear how the engagement actually forms a sealed sterile path that permits the implant to move from the cavity to the end of the funnel without contact and exposure. As seen in Figures 18-20 the funnel is folded or collapsed leaving no continuous lumen therein. It’s unclear how any path is maintained when they the connection is made. At best there is a lumen within the lower cavity, but this is not produced by the interface with the funnel.
Claim 34 is also rendered indefinite because of the requirement for the sealed first container and the sterile funnel together define a closed, sterile transfer path that maintains sterility of the implant from the sterile cavity through the internal passage of the sterile funnel until the implant is removed from the distal end. It is unclear what is meant by the phrase closed path. How can there be a structure in the funnel and closed container with a closed path? Does the applicant mean the path is closed because the funnel is folded or collapsed? If so how is there any path? Does the path just need to be closed at one end? Is the closed path the same structure as the lumen defined earlier in the claim?
Claim 35 is rendered indefinite because it is unclear how the engagement actually maintains a continuous sterile lumen. As seen in Figures 18-20 the funnel is folded or collapsed leaving no continuous lumen therein. It’s unclear how any continuous lumen is maintained when they the connection is made. At best there is a lumen within the lower cavity, but this is not produced by the interface with the funnel.
Claim 36 lacks antecedent basis for the recitation the internal surfaces of the sterile cavity. The applicant is advised to amend the claim to recite wherein internal surfaces of the sterile cavity.
Claim 39 lacks antecedent basis for the recitation the funnel. The applicant is advised to amend the claim to recite the sterile funnel.
Severe 112 Issues / No Art Rejection
It is to be noted that claims 1 and 21-29 have not been rejected over prior art. However, they may or may not be readable over the prior art but allowability cannot be determined at this time in view of the above issues under 35 USC § 112. The applicant is requested to address all of the issues outlined above and to specifically point out where the claimed elements are with respect to the elected embodiment. The applicant is advised to amend the claims to use terms consistent with the terminology used in the specification.
It appears the inventor(s) filed the current application pro se (i.e., without the benefit of representation by a registered patent practitioner). While inventors named as applicants in a patent application may prosecute the application pro se, lack of familiarity with patent examination practice and procedure may result in missed opportunities in obtaining optimal protection for the invention disclosed. The inventor(s) may wish to secure the services of a registered patent practitioner to prosecute the application, because the value of a patent is largely dependent upon skilled preparation and prosecution. The Office cannot aid in selecting a patent practitioner.
A listing of registered patent practitioners is available at https://oedci.uspto.gov/OEDCI/. Applicants may also obtain a list of registered patent practitioners located in their area by writing to Mail Stop OED, Director of the U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 21-39 have been considered but are moot because of the plethora of 112 new matter and indefinite rejections. However, the closest prior art appears to be:
5201779 with 10398543
20100133133
2021/0169666
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 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.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774