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
The Amendment filed 4/27/26 has been entered. Claim 1 has been amended. Claims 2- 20 are added. Claims 1- 20 are being addressed by this Office Action.
Election/Restrictions
Newly submitted claims 18- 20 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The method claims 18- 20 are not commensurate with the elected apparatus and would require distinct searching.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 18- 20 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Arguments
Applicant’s arguments, see pp. 7- 8 of applicant’s Remarks, filed 4/27/26, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102(a)(1) as being anticipated by Daniel have been fully considered and are persuasive because Daniel does not disclose the newly added limitation regarding wherein the passageway extends along the central axis, has a first opening at the first side, a second opening that is wider than the first opening at the second side. Therefore, the rejection has been withdrawn.
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:
“coupling surface” configured to hold the annular body to the opposing annular body when the annular bodies are assembled together in claim 1; and
“alignment feature” configured to facilitate proper alignment between the annular bodies when the annular bodies are assembled together in claim 17.
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.
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 2 is objected to because of the following informalities: line 2- “each of the spikes” should be amended to - - each of the plurality of spikes - - to maintain consistent claim terminology. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: line 4- “each of the spikes” should be amended to - - each of the plurality of spikes - - to maintain consistent claim terminology. Appropriate correction is required.
Claims 3- 5 are objected to because they depend off claim 2.
Claim 3 is objected to because of the following informalities: “ wherein the longitudinal axis of the base of each of the spikes is angled relative to the central axis when the spike is unbiased” should be amended to - - wherein the longitudinal axis of the base of each of the spikes is configured to be angled relative to the central axis when the spike is unbiased - - since the apparatus claim should include functional language to distinguish itself from a method-type claim. Appropriate correction is required.
Claim 4 is objected to because it depends off claim 3.
Claim 3 is objected to because of the following informalities: “wherein the longitudinal axis of the base of each of the spikes is angled relative to the central axis when the spike is unbiased” should be amended to - - wherein the longitudinal [[axis]] axes of the respective bases of each of the plurality of spikes is configured to be angled relative to the central axis when . Appropriate correction is required.
Claim 4 is objected to because it depends off claim 3.
Claim 4 is objected to because of the following informalities: “wherein the longitudinal axis of each of the spikes is angled along the corresponding radial direction relative to the central axis” should be amended to - - wherein the longitudinal [[axis]] axes of each of the plurality of spikes is angled along [[the]] a corresponding radial direction relative to the central axis - - to maintain consistent claim terminology. It is noted “the corresponding radial direction” lacks antecedent basis (See rejection under 35 U.S.C. 112(b) below). Appropriate correction is required.
Claim 5 is objected to because of the following informalities: lines 4- 5- “with each receptacle being elongate and oriented in a direction corresponding to the longitudinal axis of the corresponding spike” should be amended to - - with each of the plurality of receptacles being elongate and oriented in a direction corresponding to the longitudinal [[axis]] axes of [[the]] a corresponding spike - - to maintain consistent claim terminology. It is noted “the corresponding spike” ” lacks antecedent basis (See rejection under 35 U.S.C. 112(b) below). Appropriate correction is required.
Claim 9 is objected to because of the following informalities: “further comprising an alignment feature on each annular body to facilitate proper alignment between the annular bodies when the annular bodies are assembled together” should be amended to - - further comprising an alignment feature on each annular body configured to facilitate proper alignment between the annular bodies when the annular bodies are assembled together - - since the apparatus claim should include functional language to distinguish itself from a method-type claim. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: line 2- “each of the spikes” should be amended to - - each of the plurality of spikes - - to maintain consistent claim terminology. Appropriate correction is required.
Claim 12 is objected to because it depends off claim 11.
Claim 11 is objected to because of the following informalities: line 4- “each of the spikes” should be amended to - - each of the plurality of spikes - - to maintain consistent claim terminology. Appropriate correction is required.
Claim 12 is objected to because it depends off claim 11.
Claim 12 is objected to because of the following informalities: line 1- “each of the receptacles” should be amended to - - each of the plurality of receptacles - - to maintain consistent claim terminology. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: “wherein when a pin is received in a corresponding hole, a press-fit connection is formed between the pin and the hole” should be amended to - - wherein when one of the plurality of pins is received in one of the plurality of corresponding holes, a press-fit connection is formed between the pin and the hole - - to maintain consistent claim terminology. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: “further comprising an alignment feature on each annular body to facilitate proper alignment between the respective spikes and receptacles and between the respective pins and holes when the annular bodies are assembled together” should be amended to - - further comprising an alignment feature on each annular body configured to facilitate proper alignment between the corresponding ones of the plurality of spikes and receptacles and between the corresponding ones of the plurality of pins and holes when the annular bodies are assembled together - - since the apparatus claim should include functional language to distinguish itself from a method-type claim and to maintain consistent claim terminology. Appropriate correction is required.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Application claims 1- 6 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 7 and 14 of U.S. Patent No. 11,751,876. U.S. Patent No. 11,751,876 is cited in the IDS filed 10/14/24. Although the claims at issue are not identical, they are not patentably distinct from each other because
Regarding application claim 1, application claim 1 is obvious over claim 1 of U.S. Patent No. 11,751,876. It is noted “at least part of one of the annular bodies extends past the second side of the other annular body and engages the other annular body to hold the annular bodies together” is interpreted under 35 U.S.C. 112(f) as a functional equivalent of “at least one coupling surface” which is “configured to hold the annular body to the opposing annular body when the annular bodies are assembled together” in application claim 1 (See P. [0045] - - all of the coupler pins 4 are aligned with opposing holes 5, to facilitate an easy complementary assembly and locking between the opposing annuli 1).
Regarding application claim 2, application claim 2 is obvious over claim 1 of U.S. Patent No. 11,751,876.
Regarding application claim 3, application claim 3 is obvious over claim 1 of U.S. Patent No. 11,751,876.
Regarding application claim 4, application claim 4 is obvious over claim 1 of U.S. Patent No. 11,751,876.
Regarding application claim 5, application claim 1 is obvious over claim 5 of U.S. Patent No. 11,751,876.
Regarding application claim 6, application claim 14 is obvious over claim 1 of U.S. Patent No. 11,751,876. It is noted “at least part of one of the annular bodies extends past the second side of the other annular body and engages the other annular body to hold the annular bodies together” is interpreted under 35 U.S.C. 112(f) as a functional equivalent of “at least one coupling surface” which is “configured to hold the annular body to the opposing annular body when the annular bodies are assembled together” in application claim 1 (See P. [0045] - - all of the coupler pins 4 are aligned with opposing holes 5, to facilitate an easy complementary assembly and locking between the opposing annuli 1).
Regarding application claim 9, application claim 1 is obvious over claim 7 of U.S. Patent No. 11,751,876.
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.
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 3- 4 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.
Claim 3 recites “wherein the longitudinal axis of the base of each of the spikes is angled relative to the central axis when the spike is unbiased.” There is no support in the original disclosure regarding “when the spike is unbiased.”
Claim 4 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as being dependent off claim 3.
Claims 1- 17 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.
Amended claim 1 recites “a transition region with an inner width that gradually increases as the transition region extends from a distance from the second opening towards the second opening” in lines 8- 10. It is unclear how the transition region extends from the second opening towards the second opening. For the purposes of examination, claim 1 is interpreted as reciting - - a transition region with an inner width that gradually increases as the transition region extends from a distance from the first opening towards the second opening - - .
Claims 2- 9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being dependent off claim 1.
Claim 4 recites the limitation "the corresponding radial direction" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the corresponding spike" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites “wherein each of the plurality of pins is rigid and configured to maintain a same angular orientation relative to the second side to which it is connected when the pin is inserted into the corresponding hole in the opposing annular body” in lines 18- 20. Since applicant has claimed a plurality of pins, it is not clear to which pin of the plurality of pins applicant is referring.
Claim 10 recites “wherein each of the plurality of pins is rigid and configured to maintain a same angular orientation relative to the second side to which it is connected when the pin is inserted into the corresponding hole in the opposing annular body” in lines 18- 20. Since applicant has claimed a plurality of holes, it is not clear to which hole of the plurality of holes applicant is referring.
Claim 10 recites the limitation "the corresponding hole" in line 20. There is insufficient antecedent basis for this limitation in the claim.
For the purposes of examination, claim 10 is interpreted as reciting - - wherein each of the plurality of pins is rigid and configured to maintain a same angular orientation relative to the second side to which it is connected when each of the plurality of pins is inserted into [[the]] a corresponding hole of the plurality of holes in the opposing annular body - - .
Claims 11- 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being dependent off claim 10.
Allowable Subject Matter
Claims 10- 17 would be allowable if rewritten or amended to overcome the applicable claim informalities and if rewritten or amended 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.
Regarding claim 10, the prior art does not teach or suggest, alone or in combination with the remainder of the claim limitations, an apparatus for anastomosis of tubular structures comprising two implantable annular bodies, each of the annular bodies comprising: a first side, a second side, and a central axis that extends between the first and second sides, wherein the second sides of the annular bodies face one another and the central axes are coaxial when the annular bodies are assembled together; an inner wall defining a passageway for passing a tubular structure therethrough, wherein the passageway extends along the central axis and is open to the first and second sides; a plurality of spikes each extending away from the second side of the annular body to a pointed free end for piercing the tubular structure; and a plurality of pins each extending away from the second side of the annular body, wherein the plurality of pins connect to the second side at locations farther away radially from the central axis than where the plurality of spikes connect to the second side; wherein the second side of the annular body further defines a plurality of receptacles each configured to receive a corresponding one of the plurality of spikes of an opposing annular body and a plurality of holes each configured to receive a corresponding one of the plurality of pins of the opposing annular body; and wherein each of the plurality of pins is rigid and configured to maintain a same angular orientation relative to the second side to which it is connected when the pin is inserted into the corresponding hole in the opposing annular body.
The closest cited prior art reference, Daniel (US Pat. No. 4,523,592 which is cited in the IDS filed 10/14/24) discloses an apparatus for anastomosis of tubular structure comprising a first side (18), second side (16), a central axis, an inner wall defining a passageway (12), a plurality of spikes (20) and corresponding receptacles (25) (Figs. 1- 7), but Daniel does not teach or suggest, alone or in combination, a plurality of pins each extending away from the second side of the annular body, wherein the plurality of pins connect to the second side at locations farther away radially from the central axis than where the plurality of spikes connect to the second side; wherein the second side of the annular body further defines a plurality of receptacles each configured to receive a corresponding one of the plurality of spikes of an opposing annular body and a plurality of holes each configured to receive a corresponding one of the plurality of pins of the opposing annular body; and wherein each of the plurality of pins is rigid and configured to maintain a same angular orientation relative to the second side to which it is connected when the pin is inserted into the corresponding hole in the opposing annular body.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Chen (US Pat. 5,123,908);
Miller et al. (US Pat. No. 5,250,058);
Chen (US Pat. No. 5,336,233);
Regula et al. (US Pat. No. 5,346,501);
Yoon (US Pat. No. 6,036,704);
Cassell (US Pat. No. 6,666,873 B1).
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 KANKINDI RWEGO whose telephone number is (303)297-4759. The examiner can normally be reached Monday- Friday: 10:00- 5:00 MT.
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/KANKINDI RWEGO/ Primary Examiner, Art Unit 3771
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