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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Clm. 77-84 in the reply filed on 13 April 2026 is acknowledged.
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.
Claim(s) 83 and 84 is/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 83, Applicant recites “said outer plunger portion”. However, no “outer plunger portion” has been previously recited in the claims. Examiner notes that Claim 77 does make reference to a “plunger outer portion”, but it is unclear if these structures are the same or different.
Regarding Claim 84, Applicant recites “The dual chamber injection of claim 2…” However, it is noted that Claim 2 has been previously canceled and therefore it is unclear on which claim, Claim 84, was intended to depend, e.g. it is unclear if Claim 84 was intended to depend from Claim 77 (the independent claim), Claim 83 (the immediately preceding claim), Claim 82, or some other claim.
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.
Claim(s) 77 and *** is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Publication No. 2017/0319791 (“Giambattista”).
Regarding Claim 77, Giambattista discloses a dual chamber injection system (Note that the phrase “dual chamber injection system” appears ONLY in the preamble and does not set to define or set additional context or limitations to any specific structure found in the body of the claim, to wit, the body of the claim never positively makes reference to any “chamber” of the injection system or set for any specific structure which can be explicitly inferred to require a physical structure of two specific chambers. Statements in the preamble are analyzed on a case-by-case basis as to determine whether or not the confer any particular limitations to the invention or are merely recited as to set forth the broad general intents of the invention without necessarily placing an specific requirements on the invention. Again, since the body of the claim never makes reference toward a “chamber”, let alone dual chambers, it must be understood that the recitation of “dual chamber” in the preamble is not limiting inasmuch as the claimed invention only necessarily includes those elements recited in the body of the claim whereby the device need only be of a type which does not preclude the presence of additional structure which might permit a “dual chamber” function. In Giambattista the “dual chambers” could be inferred to reference the sections of the syringe barrel which are forward or rearward of the piston which separates the syringe into a forward medicament chamber and a rearward chamber for receipt of the piston rod construction or could be made in reference to the ability of the invention of Giambattista to be capable of accommodation of chamber separating inserts within the syringe barrel), the system comprising:
a guiding element (3) arranged along a longitudinal axis and configured to at least partially contain a medicament container,
said guiding element defines an inner
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surface (see Fig. 6) and at least one first guiding feature (3h) formed thereon;
a plunger rod assembly (5, 7), comprising a plunger outer portion (5) arranged along said longitudinal axis and a plunger inner portion (7) arranged concentrically within said plunger outer portion (see Fig. 8) and having at least one second guiding feature (7d) arranged on an outer surface of said plunger inner portion (Fig. 5b);
said plunger outer portion is disposed externally relative to said guiding element (see Fig. 2a);
said plunger inner portion is at least partially received into said guiding element (see Fig. 2a and 8); and
wherein said plunger rod assembly is displaceable relative to said guiding element (see Figs. 2a-2c in series) and said displacement is guided by engagement of said at least one first guiding feature with said at least second guiding feature (Par. 56).
Regarding Claim 78, Giambattista discloses the first guiding feature is a protrusion extending radially inwardly from the inner surface of the guiding element (see Fig. 6) and the second guiding feature is a guiding groove (see Fig. 5b).
Regarding Claim 80, Giambattista discloses said at least one guiding groove is continuous (see Fig. 5b) and having portions thereof that are disposed in different axial orientations along said outer surface of said plunger inner portion (see Fig. 5b).
Regarding Claim 81, Giambattista discloses said at least one guiding groove is continuous and having portions thereof that are disposed in different angular orientations along said outer surface of said plunger inner portion (see Fig. 5b).
Regarding Claim 82, Giambattista discloses in a locked operative orientation of said dual chamber injection system said plunger rod assembly is prevented from axial displacement relative to said guiding element due to engagement of said at least one protrusion with a locking portion of said at least one guiding groove (i.e. when the protrusion is presented in the proximal-most section of the guiding groove further axial displacement is prevented).
Regarding Claim 84, Giambattista discloses the plunger rod assembly is rotatable relative to said guiding element in some operative orientations when said at least one protrusion of said guiding element engages a certain portion of said at least one guiding groove, and wherein said plunger rod assembly is axially displaceable relative to said guiding element in other operative orientations when said at least one protrusion of said guiding element engages another portion of said at least one guiding groove (see Fig. 5b – note the axial extension of 7e versus the helical extrusion of 7f – see Par. 56 and 57).
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.
Claim(s) 77-78, 80-82, and 84 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0319791 (“Giambattista”) as applied above, and further in view of U.S. Publication No. 2018/0333331 (“Kalofolias”).
Regarding Claims 77-78, 80-82, and 84, should Applicant argue that the phrase “dual chamber” as recited in the preamble of the claims is limiting and that the phrase sets forth a dual medicament reservoir configuration (even though particularities of these dual chambers are never recited in the body of the claim), the following is presented. Dual medicament reservoir syringes are notoriously well-known in the art. For example, Kalofolias discloses a syringe barrel having multiple chambers to permit multi-component injectates to be delivered. It would have been obvious for one having ordinary skill in the art at the time the invention was made to modify the syringe of Giambattista to present two medicament reservoirs, as disclosed by Kalofolias, in order to allow multi-component injectates to be administered to a patient.
Allowable Subject Matter
Claim(s) 79 and 83 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims as presuming suitable satisfaction of any outstanding non-prior art issues under 35 USC 112.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 06/10/2026
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