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 .
Reissue Applications
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent No. 11,369,754 is or was involved. These proceedings would include any trial before the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Reissue Declaration
37 CFR 1.175(a) states:
The inventor’s oath or declaration for a reissue application, in addition to complying with the requirements of § 1.63, § 1.64, or § 1.67, must also specifically identify at least one error pursuant to 35 U.S.C. 251 being relied upon as the basis for reissue and state that the applicant believes the original patent to be wholly or partly inoperative or invalid by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than the patentee had the right to claim in the patent.
37 CFR 1.63(a) states:
The inventor, or each individual who is a joint inventor of a claimed invention, in an application for patent must execute an oath or declaration directed to the application, except as provided for in § 1.64. An oath or declaration under this section must:
(1) Identify the inventor or joint inventor executing the oath or declaration by his or her legal name;
(2) Identify the application to which it is directed;
(3) Include a statement that the person executing the oath or declaration believes the named inventor or joint inventor to be the original inventor or an original joint inventor of a claimed invention in the application for which the oath or declaration is being submitted; and
(4) State that the application was made or was authorized to be made by the person executing the oath or declaration.
The reissue declarations by the inventors filed on March 18, 2024, are defective (see 37 CFR 1.175 and MPEP § 1414) because the reissue declarations fail to accurately identify each inventor as an original joint inventor. Four separate reissue declarations were filed by each of the four original joint inventors; however, each reissue declaration identifies the respective inventor as “the original and first inventor” rather than an original joint inventor. See ¶ 1 and signature line of each declaration. Each reissue declaration should identify the respective inventor as a joint inventor and list all of the joint inventors. Additionally, the declarations fail to make the statement required by 37 CFR 1.63(a)(4) that “the application was made or was authorized to be made by the person executing the oath.”
The declaration by the inventors filed on November 11, 2024, appears to be a copy of the declaration submitted in the utility application for the underlying patent (U.S. Application No. 17/031,108) and does not satisfy the requirements of 37 CFR 1.175 with respect to a reissue declaration.
The examiner recommends use of Forms PTO/AIA /05 (Reissue Application Declaration by the Inventor) and PTO/AIA /10 (Supplemental Sheet naming additional joint inventors) to ensure that all formal requirements are met.
Consent of Assignee
37 CFR 3.73(c) states:
(1) In order to request or take action in a patent matter, an assignee who is not the original applicant must establish its ownership of the patent property of paragraph (a) of this section to the satisfaction of the Director. The establishment of ownership by the assignee may be combined with the paper that requests or takes the action. Ownership is established by submitting to the Office a signed statement identifying the assignee, accompanied by either:
(i) Documentary evidence of a chain of title from the original owner to the assignee (e.g., copy of an executed assignment). The submission of the documentary evidence must be accompanied by a statement affirming that the documentary evidence of the chain of title from the original owner to the assignee was or concurrently is being submitted for recordation pursuant to § 3.11; or
(ii) A statement specifying where documentary evidence of a chain of title from the original owner to the assignee is recorded in the assignment records of the Office (e.g., reel and frame number).
(2) If the submission is by an assignee of less than the entire right, title and interest (e.g., more than one assignee exists) the Office may refuse to accept the submission as an establishment of ownership unless:
(i) Each assignee establishes the extent (by percentage) of its ownership interest, so as to account for the entire right, title and interest in the application or patent by all parties including inventors; or
(ii) Each assignee submits a statement identifying the parties including inventors who together own the entire right, title and interest and stating that all the identified parties own the entire right, title and interest.
(3) If two or more purported assignees file conflicting statements under paragraph (c)(1) of this section, the Director will determine which, if any, purported assignee will be permitted to control prosecution of the application.
The Consent of Assignee (“Statement of Ownership of Patent and Assent to Reissue Application”) filed March 18, 2024, is defective because it was filed with reference to “37 CFR § 3.37(b).” See pg. 1, second paragraph. Establishment of the right of the assignee to take action is governed by 37 CFR 3.73(c). Moreover, a Statement Under 37 CFR 3.73(c) is not clearly identifiable on the record.
The examiner recommends use of Forms PTO/AIA /53 (“Reissue Application: Consent of Assignee”) and PTO/AIA /96 (“Statement Under 37 CFR 3.73(c)”) to ensure that all formal requirements are met.
Claim Rejections - 35 USC § 251
Claims 1-15 are rejected as being based upon defective reissue declarations under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175.
The nature of the defects in the reissue declarations is set forth in the discussion above in this Office action.
Objections to the Amendments - Formalities
The claim amendments filed March 18, 2024, are objected to as failing to comply with 37 CFR 1.173. Amended claims must show all changes made relative to the patent claims, with omitted text enclosed in single brackets and added text underlined. See MPEP § 1453. The claim amendments are improper because omitted text is shown in double brackets rather than single brackets.
Claim Rejections - 35 USC § 112 - Written Description
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.
Claims 1-15 are rejected under 35 U.S.C. 112(a) 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, at the time the application was filed, had possession of the claimed invention.
Regarding independent claim 1, the subject matter which lacks sufficient written description is “a retaining clip having retention barbs” (line 6) and the needle hub having a plurality of interior surfaces “configured to retain … the retaining clip” (lines 18-19). The examiner recognizes that these limitations were present in the claims as originally filed in the underlying patent application, and that the specification repeats these phrases verbatim at col. 4:10 and 21-26; col. 5:11 and 18-24; and col. 6:23 and 35-40. While there is a presumption of adequate written description of the claimed invention when the application is filed, “issues of adequate written description may arise even for original claims, for example, when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the inventor had possession of the claimed invention at the time of filing.” MPEP § 2163, subsection I.A. As further explained in MPEP § 2163.03, subsection V, “[t]he written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. ‘Even if a claim is supported by the specification, the language of the specification, to the extent possible must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement.’ Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).”
In this case, neither the specification nor the drawings of the originally filed application provide sufficient description of the retaining clip and its relationship to “interior surfaces” of the needle hub to recognize that Applicant had possession of the claimed retaining clip and needle hub with “interior surfaces configured to retain .. the retaining clip.” While Figs. 10A and 10B show a retaining clip (860) in an exploded view, the drawings do not show “retention barbs” of the retaining clip or show how the interior surfaces of the needle hub would be “configured to retain … the retaining clip.” Likewise, the specification does not explain how interior surfaces of the needle hub are configured to retain the retaining clip having retention barbs.
The specification states that “[f]urther details regarding the needle hub retaining ring 860 are described in U.S. patent application Ser. No. 62/827,767, the contents of which have been previously [i]ncorporated by reference herein.” Col. 9:48-52. However, incorporation of essential material in the specification by reference to an unpublished U.S. application is improper. See 37 CFR 1.57(d). Moreover, upon inspection, the cited unpublished provisional application (hereinafter the ‘767 provisional) does not describe a retaining clip having retention barbs and a needle hub with interior surfaces configured to retain the retaining clip. (While the ‘767 provisional does describe an anti-removal band 814 with anti-removal barbs 826, the ‘767 provisional does not describe interior surfaces of the needle hub configured to retain this component.)
In view of the foregoing, the examiner finds that the original application disclosure does not describe with sufficient specificity how the interior surfaces of the needle hub would be configured to retain a retaining clip having retention barbs, and would not reasonably convey to one of ordinary skill in the art that Applicant had possession of the claimed invention at the time the application was filed.
Claims 2-15 are rejected in view of their dependency from claim 1.
This rejection could be overcome by amending claim 1 to delete “a retaining clip having retention barbs” in line 6 and the subsequent reference to “the retaining clip” in line 19.1
Claim Rejections - 35 USC § 112 - Indefiniteness
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.
Claims 1-15 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 1, the limitations “a retaining clip having retention barbs” and a needle hub “having a plurality of interior surfaces configured to retain … the retaining clip” render the claim indefinite due to the apparent lack of correspondence with the disclosed invention. See MPEP § 2173.03. The retaining clip is labeled with reference number “860” in Figs. 10A-B. The retaining clip is not shown in relation to interior surfaces of the needle hub. Neither the specification nor the drawings explain what it means for interior surfaces of the needle hub to be “configured to retain … the retaining clip.” Additionally, the claim does not clearly describe any structural or functional cooperative relationships between the retaining clip and the other parts of the syringe. For these reasons, it is unclear what structural configuration of the retaining clip and needle hub is being claimed.
Claims 2-15 are rejected in view of their dependency from claim 1.
This rejection could be overcome by amending claim 1 to delete “a retaining clip having retention barbs” in line 6 and the subsequent reference to “the retaining clip” in line 19.2
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Schluzas et al. (US Patent Pub. 2015/0148748, hereinafter Schluzas).
Regarding claim 1, Schluzas discloses a syringe assembly (Figs. 6A-V) comprising:
a syringe body (46, ¶ 18) having a syringe interior, a longitudinal axis, a syringe body proximal end, a syringe body distal end, and a needle attachment interface (luer lock adapter 44 with female luer base 53) disposed at the syringe body distal end (¶ 18);
a needle assembly (needle 54, Figs. 6F-I) having a needle proximal end and a needle distal end (¶ 19);
a retaining clip (anchoring element 57, Figs. 6G-I) having retention barbs (32; ¶ 19);
a gasket (seal 52, see Figs. 6F, 6P, 6R) configured to be compressed to provide a liquid-tight seal around an outer diameter of the needle assembly (i.e., around outer diameter of cannula hub 56 of needle 54; see Figs. 6P and 6R) and the syringe body distal end (at female luer base 53, Figs. 6P and 6R);
a needle latch assembly (needle latch 50, ¶ 19) comprising:
first and second latching tabs (flexible arms 75) configured to retain the needle assembly in a close state (when the arms 75 “grasp the needle,” ¶ 19) and to be plastically deformed to an open state to release the needle assembly (“flexed to release the needle,” ¶ 19; see Figs. 6T and 6V showing that the arms 75 are permanently deformed once flexed3); and
a gasket backstop (flat base of latch 50; see annotated Figs. 6F and 6P below) configured to provide a flat surface for compression of the gasket (52), wherein the first and second latching tabs (75) are spaced apart from the gasket (52) such that neither of the first and second latching tabs (75) contact the gasket (52) during compression of the gasket (52); and
a needle hub (nose cone 49) having a plurality of interior surfaces configured to retain the needle latch assembly (50), the gasket (52), the retaining clip (57), and the syringe body distal end (at female luer base 53) in a sealed configuration to prevent liquid from leaking to an exterior of the needle hub during injection using the syringe assembly (“[t]he seal (52) provides a barrier to drug leakage around the periphery of the needle (54),” ¶ 19);
wherein the needle assembly (54) is configured to be retracted into the syringe body (46) after injection using the syringe assembly (see Figs. 6U-V, ¶ 22).
PNG
media_image1.png
486
474
media_image1.png
Greyscale
PNG
media_image2.png
274
480
media_image2.png
Greyscale
Allowable Subject Matter
Pending correction of the reissue declarations to overcome the rejections under 35 U.S.C. 251 set forth above:
Dependent claims 2 and 14 would be allowable if rewritten to overcome the rejections under 35 U.S.C. 112(a) and 112(b) set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. Dependent claims 3-13 and 15 would be allowable by virtue of their dependency from claims 2 and 14, respectively.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art is Schluzas, as discussed above for claim 1.
Regarding claim 2, Schluzas does not teach the needle latch assembly comprising a cage including all the features of a flat body, first and second arms, and first and second openings in the configuration claimed, to allow passage of the needle assembly through the first larger opening and to prevent passage of the needle through the second smaller opening until the first and second latching tabs are deformed. Regarding claim 14, Schluzas does not teach the needle latch assembly comprising all the features of a top flat disc-shaped body, a bottom flat disc-shaped body, a plurality of joining members, and first, second, and ovoid openings in the configuration claimed, to allow passage of the needle through the second larger opening and to prevent passage of the needle through the first smaller opening until the first and second latching tabs are deformed. The examiner does not find these features to be taught in the prior art. In view of the foregoing, it is the examiner’s opinion that these features describe a nonobvious improvement to the syringe assembly.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Laura L. Davison whose telephone number is (571)270-0189. The examiner can normally be reached Monday - Friday, 8:00 a.m. - 4:00 p.m. ET.
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, Eileen Lillis can be reached at (571)272-6928. 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.
/Laura Davison/Reexamination Specialist, Art Unit 3993
Conferees:
/SARAH B MCPARTLIN/ /EILEEN D LILLIS/Reexamination Specialist, Art Unit 3993 SPRS, Art Unit 3993
1 For clarity of the record, the examiner notes that a broadened claim can be presented in this reissue application because the reissue declarations, which were filed within two years from the patent grant, unequivocally indicated an intent to broaden by stating “U.S. Patent No. 11,369,754 is at least partly inoperative because it claims less than inventor had a right to claim.” ¶ 3. See MPEP § 1412.03, subsection IV. Additionally, the deletion of the retaining clip would not raise new issues with respect to improper recapture or original patent under 35 U.S.C. 251 because this limitation was not added or argued during prosecution of the underlying application in order to obtain allowance of the patent, such that deletion of this limitation would not improperly recapture surrendered subject matter. See MPEP § 1412.02.
2 See fn. 1.
3 As further evidence in support of the examiner’s interpretation of Schluzas as teaching that the latching tabs (75) are plastically deformable, see US Patent No. 9,861,762 by the same inventors, disclosing similar latch members (54, Figs. 10E-F) which are pulled apart (in direction 90) and left “permanently relatively open” for retraction of the needle. Col. 7:27-31.
Prosecution Insights