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 .
Response to Amendment
This office action is responsive to the amendment filed on 4/2/2026. As directed by the amendment: claim(s) 1-2, 4, 6-7, and 20-22 have been amended, claim(s) 5 and 8-19 have been cancelled. Claims 20-22 are withdrawn from consideration, see office action filed 1/2/2026. Thus, claims 1-2, 4, and 6-7 are presently pending in this application. Applicants’ amendments to the drawings and specification are accepted.
Response to Arguments
Applicant's arguments filed 4/2/2026 have been fully considered but they are not fully persuasive.
Regarding applicant’s argument regarding drawing objections on page 8:
Applicant's present amendment resolves the preceding office action’s stated objections.
Regarding applicant’s argument regarding the preceding 112b rejection on page 9:
Applicant's present amendment resolves the preceding office actions stated 112b rejection of claim 7.
Regarding applicant’s argument regarding the independent claims on page 9-11:
Applicant argues certain differences between the prior art and claimed embodiments of applicant’s disclosure serve allegedly different functions and therein cannot be relied upon for teaching certain functional claimed limitations.
In response to applicant's argument that the claimed clip taught by the prior art of Calderon cannot be considered configured to hold an anchor for device packaging and transfer, a recitation of the intended use of the 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. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicant argues that a person of ordinary skill in the art would not be motivated to combine the teachings of Calderon with the disclosure/teachings of Kauper and Elmalek to the claimed clip limitation because Calderon’s alleged teaching of a connector for irreversibly holding an element could not considered applicable to the claimed anchor for device packaging and transfer through automated manufacturing operations, storage, and septic transfer to the surgical site, and thus not irreversible.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a clip securing to an anchor in a reversible manner to facilitate automated manufacturing operations, storage, and aseptic transfer and eventual release once the device is implanted) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues certain secondary considerations and allegations of patentability of the currently claimed embodiments.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Examiner notes for applicant that if certain amendments to the independent claim, incorporating the subject matter of claims 4, 6, and 7, and specifically delineating the manner that certain structural elements of the invention contribute to the claimed functions of the anchor being “configured to affix the device to tissue”, the clip being “configured to enable packaging and/or transfer of the device”, and the clip being functionally capable releasing the device after implantation as applicant discussed in their remarks filed 4/2/2026, then such amended claims could distinguish the amended claims from the prior art of record and constitute allowable subject matter. Depending on the scope of the amendments, they may require further search and consideration before a determination of allowability or overcoming the prior art rejection of record may be determined.
Examiner also further notes that the claims could be amended to distinguish the subject matter of claim 7 from the prior art of Calderon in the manner that certain elements of applicant’s disclosure pertaining to the clip are not integral with one another, or are separable from one another, such that the claimed clip could not be interpreted as a singular clipping structure but multiple structures mated together. Such amendments could distinguish the claims from prior art rejection of record and possibly constitute allowable subject matter, however further search and consideration may be required.
Regarding applicant’s argument regarding dependent claims on page 11:
Applicant argues that their preceding arguments render the independent claims allowable, and consequently likewise the dependent claims are allowable, and claims 20-22 are eligible for rejoinder.
See examiner's rejection as necessitated by the amendment, below, detailing the prior art which discloses/teaches the limitations of the dependent claims and pending independent claim 1.
Specification
The abstract of the disclosure is objected to because of undue length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Regarding claim 1,
The claim recites “docking means” in terms of being a part of a filling port and being connected to said filling port and being connected to a micro-diameter tube. However, regarding these docking means applicant’s disclosure only recites in paragraph 18 that “a filling port 120 – having a docking means 130 which may also be referred to a port assembly, connected at a first end to the filling port 120, and a micro- diameter tube (MDT) 140 which extends therefrom”. Applicant’s disclosure does not recite explicit structure defining the docking means other than it may be an element of a filling port and being connectable to said filling port and a tube at distinct ends.
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 1-2, 4, and 6-7 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.
Regarding claim 1
The claim recites such claim language of “a filling port having docking means connected at a first end to the filling port, and connected at a second end to a micro-diameter tube (MDT) which extends therefrom” which due to the nature of its sentence structure and claimed relationships is unclear as it not clear whether the claimed first end and second end are considered to be an element of the filling port or docking means, and further whether the micro-diameter tube is considered to extended from the second end, the filling port, or the docking means. For examination purposes the claims are to be interpreted as “a filling port having docking means connected at a first end of the docking means to the filling port, and connected at a second end of the docking means to a micro-diameter tube (MDT) which extends from the second end of the docking means” in light of applicant’s remarks filed 4/2/2026 and figure 1 of applicant’s disclosure. Examiner further notes applicant’s paragraph 26 which details the only explicitly defined first end and second end as being relative to ends 140-2 and 140-4 of tube 140, however the claims as presently written do not appear to be referencing such ends in their present form.
Regarding claim 7
Claim 7 is considered indefinite as it depends upon a cancelled claim 5, rendering the claim unclear as to the scope of the claimed subject matter. For examination purposes to be interpreted as depending upon claim 2 in light of applicant’s claims filed 12/1/2025 detailing the claims which the cancelled claim 5 depends from.
Regarding claim 2, 4, and 6-7
The aforementioned claims are at least rejected for being dependent upon and incorporating the rejected subject matter of claim 1.
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.
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.
Claims 1-2, 4, and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over US 20150073381 A1, henceforth written as Kauper, in view of US 20150073381 A1, henceforth written as Elmaleh, and US 20140074047 A1, henceforth written as Calderon.
Regarding Claim 1,
Kauper discloses a medical device system comprising:
an analyte diffusive implantable device (ADID) which comprises:
(paragraph 73; implantable cell culture device/cartridge as shown in Figure 1)
a cavity
(paragraph 94; the inner space of each chambers that contain the core which function as a reservoir);
a cell-scaffolding material (CSM) arranged within the cavity and configured to hold or otherwise retain a plurality of living cells;
(paragraph 94; a matrix disposed in the core where the encapsulated cells are distributed )
and a porous membrane at least partially enclosing the cavity
(paragraph 102; the surrounding semi-permeable membrane is formed into a porous structure in each chamber),
wherein at least a portion of the membrane is adhered to the CSM by a high durometer adhesive which creates a hemispheric seal at both ends of the membrane
(paragraph 104; sealing the capsules by polymer adhesives to form a hermetic seal at each end of the device);
and a filling port having
(access port as discussed in paragraphs [0091] and [0092] and shown in Figure 3, see annotated Figure 3 below)
docking means connected at a first end to the filling port, and
(see annotated Figure 3 below)
connecting at a second end to --a tube which extends therefrom,
(see annotated Figure 3 below)
an anchor arranged on one end of the ADID
(see annotated Figure 3 below)
[and the anchor is configured to be held by a structure]
(paragraph 21+103)
wherein the [tube] is sealed at a distal end to the filling port and at a proximal end to the cavity of the ADID, so as to establish an integral, cell-filling pathway there-within
(see annotated Figure 3 below and discussion of accessing chambers within the cartridge through an access port in paragraphs [0091] and [0092]).
Examiner notes that the tube as shown in the annotated Figure 3 below connect the chambers within the cartridge with the filling port and therefore is sealed at the chambers/cavity of the ADID at one end and the filling port at the other end.
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Kauper discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
A micro diameter tube
However, Elmaleh teaches a therapy retaining device including a filling port having a micro diameter tube, see paragraph 35-36 and fig 1 detailing micro tube extension 301.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to implement the specific sized tube for filling a therapy retaining device teachings of Elmaleh to the tube of Kauper in order to advantageously arrive at an invention which enables fast filling, see paragraph 29 of Elmaleh, therein improving the manufacturing process.
Kauper in view of Elmaleh discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
A clip for holding the anchor
However, Calderon teaches a structure for securely holding a tube, see figures 2-5 illustrating clamp 30 forming a secure grip on tubing 43. Examiner notes that Calderon is demonstrated as being functionally capable of holding the anchor disclosed by Kauper in the claimed manner as Calderon demonstrates clamp 30 may securely retain a tubing 43, which is not dissimilar in form to the tubing forming Kauper’s anchor.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to implement Calderon’s teachings of providing a clamp to secure a tubular element, to the tubular anchor element disclosed by Kauper in order to advantageously arrive at an invention with a means for securing to an anchor in a manner which maintains adequate compression on the tubing and thus an adequate securement of the anchor relative to the holding structure, see paragraph 37 of Calderon. Further, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Regarding claim 2, the modified invention of Kauper in view of Elmaleh and Calderon discloses:
The system of claim 1, wherein the filling port comprises a temporary filling port.
Kauper: (figures 1+10 illustrate the invention of Kauper in a deployment ready state, where the noted filling port has been disconnected from the noted ADID, thus the noted filling port can be considered a temporary filling port in that it some points in time fills the ADID, and at other points in time, does not fill the ADID)
Regarding claim 4, the modified invention of Kauper in view of Elmaleh and Calderon discloses:
The system of claim 1, wherein the anchor is configured to affix the device to tissue.
Kauper: (paragraph 103)
Examiner further notes in light of the modification made in claim 1 above, the implementation of Calderon’s clamp 30 advantageously provides further elements mated to the claimed anchor which are functionally capable of being implanted with such elements, as clamp 30 is formed from a medically appropriate and sterilizable material see paragraph 29 of Calderon, and in the manner that clamp 30 is an additional element firmly secured to Kauper’s anchor could provide additional means for firmly securing the device to the tissue due to the nature of the connection between Kauper’s anchor and Calderon’s clip.
Regarding claim 6, the modified invention of Kauper in view of Elmaleh and Calderon discloses:
The system of claim 1, wherein the clip is configured to enable packaging and/or transfer of the device.
Examiner notes that in in light of the modification made in claim 1 above, Calderon’s clip, clamp 30, can be considered functionally capable of enabling packaging/transfer of the device in that when Calderon’s clamp 30 is in a closed state around Kauper’s anchor the clamp 30 forms a secure bond with the anchor such that an operator or machine could choose to manipulate the modified invention by a multitude of elements to facilitate movement of the modified invention by manipulating Kauper’s anchor and/or Calderon’s clamp 30 which is securely mated to the anchor.
Regarding claim 7, the modified invention of Kauper in view of Elmaleh and Calderon teaches :
The system of claim 5, wherein the clip comprises:
Calderon: (clamp 30; fig 2-7)
a proximal end and a distal end;
(see examiner’s annotation of Calderon’s figure 2 below)
a first jaw having
(leg 36; fig 2)
a corresponding first distal jaw end;
(tooth 74; fig 4)
a second jaw having
(leg 38; fig 2)
a corresponding second distal jaw end
(tooth 767; fig 5-6)
configured for movement relative to the first distal jaw end;
(see Figures 4 and 5 showing tooth 74 at different positions relative to tooth 76)
a first jaw extension integral with the first jaw;
(arm 68, gap 70, cutout 112, Figure 4)
a second jaw extension integral with the second jaw; and
(arm 104; fig 2)
at least two proximal extensions integral with the first jaw;
(see examiner’s annotation of Calderon’s figure 2 below)
wherein: the first jaw extension includes a first projection,
(arm 68; fig 2)
a first receiving area and
(gap 70; fig 4)
a second receiving area;
(cut out 112; fig 4)
the second jaw extension includes a flexible projection;
(arm 72; fig 4)
the first receiving area being configured to receive an end of the flexible projection;
(paragraph 41; gap 70 receives arm 72; fig 5)
the second receiving area being configured to receive the second jaw extension and move therein; and
(paragraph 44; cut out 112 receives arms 104; fig 5)
the first distal jaw end of the first jaw is closed with respect to the second distal jaw end of the second jaw in a resting position.
(tooth 74 and tooth 74 are engaged as shown in the resting position of Figure 5)
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Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure, particularly subject matter of the independent claim(s) pertaining to the clip configured to hold the anchor.
US 20190247042 A1
US 20210228334 A1
US 20230293273 A1
US 20180325661 A1
US 20180296334 A1
US 20080281356 A1
US 5330442 A
US 5695505 A
US 20200029957 A1
US 20140031864 A1
US 5474572 A
US 20050240203 A1
US 20070179530 A1
US 9089313 B2
US 5409499 A
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 FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern.
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, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FORREST B DIPERT/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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