DETAILED CORRESPONDENCE
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/6/24 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-14 are pending.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “means for rotating” in line 4 of claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
As to the “means for rotating”, and as best understood, the specification describes that the rotary drive means may be manual or motorized (page 5 of the instant specification) and the examiner will interpret the means as any structure that supports the rotation of the filter, whereby the portion that helps support rotation could be turned in any manner.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 5 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim. Claim 5 refers back to “claim 1 to 3” where it does not refer to the claims in the alternative. See MPEP § 608.01(n). Accordingly, the claim 5 not been further treated on the merits.
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 2, 3, 6-14 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 pre-AIA the applicant regards as the invention.
As to claim 2, it is unclear what “said means” is referring to in line 4 because “a means” and “rotary drive means” have each been discussed in claim 1 and 2, respectively. The examiner believes that the means for rotating of claim 1 is the same as the rotary drive means and will interpret the claims as such for purposes of examination. However, the examiner does request that applicants use consistent terminology when describing the same features. Claim 3 is rejected based on further claim dependency.
Claims 6 and 7 each recite “the rotary drive means” which has not been previously mentioned. Therefore, this limitation is unclear and has insufficient antecedent basis. The examiner believes that the means for rotating of claim 1 is the same as the rotary drive means and will interpret the claims as such for purposes of examination. However, the examiner does request that applicants use consistent terminology when describing the same features.
As to claim 8, it is unclear whether the filter is actually rotating or not. The filter delimits a centrifugation chamber (second clause) and the collector plate (last clause) is then recited as moving along an axis of rotation of the filter. The issue is that the filter has not been previously recited as rotating. The examiner believes that the filter is rotating and requests clarification. Similarly, claims 13 and 14 are unclear as to how the filter is driven. Because the filter is not recited as rotating then it is unclear what or why the filter would be driven without clearly reciting how the filter can be moved.
Claims 9-14 are rejected based on further claim dependency.
Appropriate correction and/or clarification is required.
Claim Rejections - 35 USC § 103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 4, 6-8, 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Leach et al (US 20100317099; hereinafter “Leach”) in view of Ricordi et al (US 20230160791; hereinafter “Ricordi).
As to claim 1, Leach teaches a device for purifying adipose tissue (Leach; Title), comprising at least one sealed enclosure (Leach teaches that cap on 72 seals the container 40; Fig. 1; [34]), a filter present in the sealed enclosure, said filter delimiting a centrifugation chamber for centrifuging adipose tissue, and a means for rotating the filter, the filter having a pore size configured to allow a liquid medium to pass and to retain adipose tissue (Leach teaches filter 60 in the centrifugation chamber, where the filter has a pore size to retain adipose tissue; [29, 33]. Leach teaches that the filter is rotated via gear/connecting member 112 and shaft 110; [38], Fig. 1).
Note: The instant Claims contain a large amount of functional language (ex: “configured to…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
Leach does not specifically teach a collector plate present in the separation chamber, the collector plate being able to move in translation along the vertical axis of the chamber. However, Ricordi teaches the analogous art of a device for processing and separating tissue through a filter (Ricordi; Title, [27, 47-50]) with a collector plate present in the separation chamber, the collector plate being able to move in translation along the vertical axis of the chamber (Ricordi teaches that plate 106 rotates along a vertical shaft and also moves up and down to adjust the position and surpass blockages to help process large tissue chucks; [39-41], Fig. 1-2). It would have been obvious to one of ordinary skill in the art to have modified the centrifugation chamber for separating tissue through a filter as in Leach to have included a collector plate that translated along the vertical axis of the chamber of Ricordi, the resulting combination being that the collector plate of Ricordi translated along the vertical axis of the centrifugation chamber of Leach, because Ricordi teaches that a rotating and vertically translating plate can assist in processing large tissue chucks (Ricordi; [41]).
As to claim 4, modified Leach teaches the device according to claim 1, further comprising a stiffening element present between the sealed enclosure and the filter (Leach teaches a stiffening element as the outside wall 50, or as supporting wall 46; Fig. 1, [26-33]. The examiner is interpreting any supporting structure as the stiffening element).
As to claim 6, modified Leach teaches the device according to claim 1, wherein the rotary drive means of the filter is manual (The examiner notes that the drive means has been interpreted as the component that turns the filter; see 112(f) above. Leach teaches a rotator for the motor; see above. There are controls for the motor provided such that a user can manually control the power which would mean that the filter rotation is driven manually; [37], Fig. 1).
As to claim 7, modified Leach teaches the device according to claim 1, wherein the rotary drive means of the filter comprises an electric motor (Leach; [37]).
As to claim 8, Leach teaches a device for purifying adipose tissue (Leach; Title), comprising: at least one sealed enclosure (Leach teaches that cap on 72 seals the container 40; Fig. 1; [34]); a filter present in the sealed enclosure, said filter delimiting a centrifugation chamber for centrifuging adipose tissue, wherein the filter has a pore size configured to allow a liquid medium to pass and to retain adipose tissue (Leach teaches filter 60 in the centrifugation chamber, where the filter has a pore size to retain adipose tissue; [29, 33]. Leach teaches that the filter is rotated via gear/connecting member 112 and shaft 110; [38], Fig. 1).
Leach does not specifically teach a collector plate present in the separation chamber, the collector plate being able to move in translation along the vertical axis of the chamber. However, Ricordi teaches the analogous art of a device for processing and separating tissue through a filter (Ricordi; Title, [27, 47-50]) with a collector plate present in the separation chamber, the collector plate being able to move in translation along the vertical axis of the chamber (Ricordi teaches that plate 106 rotates along a vertical shaft and also moves up and down to adjust the position and surpass blockages to help process large tissue chucks; [39-41], Fig. 1-2). It would have been obvious to one of ordinary skill in the art to have modified the centrifugation chamber for separating tissue through a filter as in Leach to have included a collector plate that translated along the vertical axis of the chamber of Ricordi, the resulting combination being that the collector plate of Ricordi translated along the vertical axis of the centrifugation chamber of Leach, because Ricordi teaches that a rotating and vertically translating plate can assist in processing large tissue chucks (Ricordi; [41]).
As to claim 11, modified Leach teaches the device according to claim 8, further comprising a stiffening element present between the sealed enclosure and the filter (Leach teaches a stiffening element as the outside wall 50, or as supporting wall 46; Fig. 1, [26-33]. The examiner is interpreting any supporting structure as the stiffening element).
As to claim 12, modified Leach teaches the device according to claim 8, wherein the filter is made of a rigid self-supporting material (Leach teaches that the filter supports itself where this material supports itself while also maintaining and supporting its structure to allow fluids to pass through the pores/holes; [29-32], Fig. 1).
As to claim 13, modified Leach teaches the device according to claim 8, wherein the filter is driven manually (The examiner notes that the drive means has been interpreted as the component that turns the filter; see 112(f) above. Leach teaches a rotator for the motor; see above. There are controls for the motor provided such that a user can manually control the power which would mean that the filter rotation is driven manually; [37], Fig. 1).
As to claim 14, modified Leach teaches the device according to claim 8, wherein the filter is driven with an electric motor (Leach; [37]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of copending Application No. 18717120 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of ‘120 teaches a device with a sealed enclosure, a filter that delimits a centrifuge chamber, and a rotary plate connected to the filter to rotate, and claim 4 of ‘120 discloses a collector plate translating along the axis of rotation of the filter. Thus, all of the elements of the invention recited in the instant claims are encompassed by the claims of copending Application No. 18717120 (reference application).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 2-3 and 9-10 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance:
The prior art does not teach or suggest the limitations of claim 1 with a threaded rod extending in the centrifugation chamber and cooperating with a tapped portion of the collector plate, the threaded rod being connected to rotary drive means of the filter, said means being configured to drive the threaded rod in rotation, in a direction of rotation opposite to the direction of rotation of the filter.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN R WHATLEY whose telephone number is (571) 272-9892. The examiner can normally be reached Mon- Fri 8am-5pm.
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, Charles Capozzi can be reached at (571) 270-3638. 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.
/Benjamin R Whatley/Primary Examiner, Art Unit 1798
Prosecution Insights