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 .
Information Disclosure Statement
The information disclosure statement(s) filed on the record are in compliance with the content requirements of 37 CFR 1.97 and 37 CFR 1.98 and have been considered.
Election/Restrictions
Applicant's election with traverse of Species B, sub-species 1, in the reply filed on 07/15/2026 is acknowledged. The elected species and sub-species correspond to Figs. 4A-4C (erroneously identified as "Figs. 4C-4C" in the election/restriction requirement) with an energy source that comprises a spring.
Applicant noted that claim 11 is withdrawn as being directed to a non-elected species. Additionally, claims 7 and 9 have been withdrawn as being directed to a non-elected species (Species B does not show the connector assembly comprising a hollow rod or the viscous damping mechanism is coupled to the proximal end of the plunger).
Accordingly, claims 1-6, 8, 10 and 12-16 are currently pending and considered below.
The traversal is on the ground(s) that there would be no serious search burden on the Examiner to search all of the species and subspecies (see Remarks dated 07/15/2026, bottom of pg. 1 to top of pg. 2, alleging that the search required for the non-elected species and sub-species "would substantially overlap" with the search of the elected species and sub-species). This is not found persuasive. In this case, it would have been necessary to search for one of the inventions in a manner that is not likely to result in finding art pertinent to the other inventions. For example, different search queries would be employed based on the configuration of the damping mechanism relative to the plunger and the energy source. Further, spring energy sources are often distinguished by from gas pressure energy sources by CPC classification. Fluid pressure actuators, pressurized containers and compressed gas energy sources are often classified in CPC F15B, F17C and B65D. Spring-based energy sources are often classified in F16F, F16H and F16P.
The requirement is still deemed proper and is therefore made FINAL.
Examiner also notes Applicant's points of clarification on pg. 2 of the Remarks filed 07/15/2026. Applicant's understanding is consistent with the Examiner's intent in drafting the election/restriction requirement.
Drawings
Examiner notes that the drawings do not show the features of claim 7 or claim 9 ("connector assembly [comprising] a hollow rod" in claim 7 and the "viscous mechanism …coupled to the proximal end of the plunger" in claim 9). Since these claims have been withdrawn, a drawing objection has not been applied. However, it is noted that 37 CFR 1.83(a) requires that the drawings show every feature of the invention specified in the claims.
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: "energy source" (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.
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 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 3 and all claims depending therefrom 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 3, the limitation "the housing [of the viscous damping mechanism] is disposed proximal to the energy source" is indefinite in light of claim 1 (upon which claim 3 depends), which recites that the viscous damping mechanism is "disposed proximal to at least a portion of the energy source". It is not clear how the housing being "disposed proximal to the energy source" further limits the invention where "the housing [is] disposed proximal to at least a portion of the energy source". 35 U.S.C. 112(d) states that a dependent claim "shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed."
For the purpose of examination, claim 3 will be interpreted to mean that a portion of the housing is disposed proximal to a proximal end of the energy source.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-6, 8, 10, 12, 13, 15 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cowe (WO 2012/098371 A1, hereinafter "Cowe").
Regarding claim 1, Cowe discloses an injection device (see Fig. 4) for drug delivery, the injection device comprising:
a container 8 (body of syringe 7; see Fig. 2 illustrating the container that is not shown in Fig. 4) for storing a drug;
a stopper 12 (see Fig. 2 illustrating the stopper that is not shown in Fig. 4) moveably disposed in the container for expelling the drug (the stopper 12 has a rubber bung 13 attached at one end);
a plunger 51 (see Fig. 4) having a proximal end and a distal end 52 (see Fig. 4), wherein the distal end is initially spaced from the stopper by a gap "B" (see Fig. 2 illustrating the gap that is not shown in Fig. 4);
an energy source 43 configured to move the plunger in a distal direction to close the gap between the plunger and the stopper and cause the plunger to act on the stopper to expel the drug from the container (see pg. 10, line 26 to pg. 11, line 2, disclosing that the energy source 43 expands and therefore exerts force on the plunger 51, such that the plunger 51 accelerates movement of the stopper 12 into the container 8; this force is sufficient to inject medication through the needle 11 at a desired rate);
a viscous damping mechanism (portion of housing 39 enclosing channel 46 and chamber 45) and disposed proximal to at least a portion of the energy source (see Fig. 5, showing the viscous damping mechanism disposed proximal to the distal end of the drive spring) and configured to limit a velocity of the plunger at least when the plunger moves to close the gap between the plunger and the stopper (see pg. 10, lines 1-13, disclosing: (1) the device is triggered to cause the drive spring 43 to expand axially and in the proximal direction, pushing a first member 47 and in turn the plunger 51 axially towards the distal end of the device; (2) air is sucked into proximal chamber 44 through the small channel 46 connecting the proximal and distal chambers, and due to the small diameter of the channel, the flow of air between the chambers is restricted, resulting in a damping of the movement of the member 47 through the proximal chamber and therefore a damping of the movement of the plunger 51; and (3) the damping mechanism "damps the kinetic energy applied by" the member 47 to the stopper 12 compared to an undamped member).
Regarding claim 2, Cowe discloses the injection device of claim 1, wherein the viscous damping mechanism comprises a housing 39 (see Fig. 4) and a working fluid (i.e., air) disposed in the housing.
Regarding claim 3, Cowe discloses the injection device of claim 2, wherein the housing is disposed proximal to the energy source (interpreted to mean that a portion of the housing is disposed proximal to a proximal end of the energy source; the housing 39 has a proximal-most flange under which the proximal end of the spring rests).
Regarding claim 4, Cowe discloses the injection device of claim 3, wherein the housing is disposed proximal to the plunger (see Fig. 5, showing the portion of the housing 39 encompassing the channel 46 and chamber 45 is proximal to the plunger 51).
Regarding claim 5, Cowe discloses the injection device of claim 2, comprising a connector assembly 47 (see Fig. 4) operably connecting the plunger and the viscous damping mechanism, wherein the working fluid contacts at least a portion of the connector assembly to generate viscous friction for resisting movement of the connector assembly (working fluid is in the chamber 44 in contact with the proximal end of the assembly 47, and generates viscous friction as it is forced into the channel 46).
Regarding claim 6, Cowe discloses the injection device of claim 5, wherein the connector assembly is configured to move jointly with the plunger at least when the plunger moves to close the gap between the plunger and the stopper (when the connector assembly 47 pushes on the distal end of the plunger 51, the two move jointly in order to cause the plunger 51 to move toward the stationary stopper 12).
Regarding claim 8, Cowe discloses the injection device of claim 2, wherein the working fluid comprises at least one of oil, mineral oil, silicone, water, and air (i.e., air).
Regarding claim 10, Cowe discloses the injection device of claim 1, wherein the energy source comprises a spring 43 (see Fig. 4).
Regarding claim 12, Cowe discloses the injection device of claim 1, comprising an outer casing 19 (see Fig. 4), wherein the container is disposed within and fixedly coupled with the outer casing (the container is dropped into the outer casing 19 and then held fixedly therewith so that movement of the outer casing 19 causes movement of the container; see pg. 3, lines 11-13).
Regarding claim 13, Cowe discloses the injection device of claim 12, wherein the container comprises a syringe (see pg. 3, line 20).
Regarding claim 15, Cowe discloses the injection device of claim 14, comprising a removable shield (see Fig. 2, showing the shield [not labeled] fitted over the needle coupling 10; this feature would be present in Fig. 4).
Regarding claim 16, Cowe discloses the injection device of claim 15, wherein the syringe is a prefilled syringe (see pg. 4, lines 34-35, disclosing medication in the syringe).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Cowe in view of Wotton et al (U.S. Pat. 8,945,063 B2, hereinafter "Wotton").
Regarding claim 14, Cowe discloses the injection device of claim 13, comprising a guard member 3 (see Fig. 2, showing the guard member 3 not shown in Fig. 4) movably disposed at a distal end of the outer casing for selectively covering a needle of the syringe, but does not appear to disclose that the guard member is spring-biased.
Wotton discloses an injection device comprising a spring-biased guard member 66 (biased by spring 72; see col. 31, lines 32-40).
A skilled artisan would have found it obvious at the time of the invention to modify the guard member of Cowe to be spring biased, as taught in Wotton, as the spring would have been expected to be useful to normally maintain the guard in its protecting position and to permit the guard to move back into its protecting position after use.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 07/28/2026
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