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
This office action is responsive to the amendment filed on 5/4/26. As directed by the amendment: claims 1, 4, 7, 12, 14, and 15 have been amended, claims 5 and 8-11 have been cancelled, and no new claims have been added. Thus, claims 1-4, 6, 7, and 12-15 are presently pending in this application, claims 1-4, 6, and 7 being withdrawn from consideration.
The amendments to the claims are sufficient to overcome some of the rejections under 35 U.S.C. 112(b) from the prior action, with the exception of rejections noted below.
Claim 14 has been amended to correct the improper multiple dependency identified in the prior office action, and will now be 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 12-15 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 12, it is unclear what the intended scope of the transitional phrase “comprising at least” is relative to the traditional phrase “comprising”.
Further regarding claim 12, the phrase “the proximal facing surface of the plunger head” lacks antecedent basis in the claim.
Regarding claim 14, it is unclear which “parts” of the syringe assembly according to claim 12 are encompassed or not encompassed by the preamble, and whether the claim requires the parts to be configured as claimed in claim 12. Claim 14 goes on to recite elements as new elements which appear to have been previously recited in parent claim 12. It is unclear if the elements are intended to refer back to previously recited elements or add new elements. For the purposes of examination, elements of claim 14 which reflect limitations already recited in claim 12 are interpreted to be reciting the same element from claim 12. Elements in claim 14 which are initially recited in parent claim 12 need to utilize “the” or “said” to indicate such a connection to antecedent basis for clarity.
Claims 13 and 15 are rejected as dependent on claim 12.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 14 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The preamble of claim 14 only cites “parts” of parent claim 12, and thus appears to fail to include all the limitations of the claim upon which it depends. It additionally appears that claim 14 may be reciting elements already presented from claim 12 without reciting any additional elements that would further limit claim 12. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 12, 14, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Runfola (US 20100076378).
Regarding claim 12, as best understood, Runfola discloses a syringe assembly for administering a liquid composition to a human or animal body (assembly as illustrated in fig. 9, where thumb pad 238 is provided with the surface embodiment of fig. 10F, as described in par. 0055), comprising at least: a longitudinal syringe barrel 122 having an inner lumen (interior of 122) for receiving and storing a liquid composition to be administered (see fig. 9), a finger grip coupled to a proximal end of said barrel (128 in fig. 1, unlabeled in fig. 9), and a plunger (comprising at least 230, 232, and 238) having a plunger rod 230 and a plunger head (proximal-most portion of 230 at the top of fig. 9), the plunger rod being disposed at least partly within the inner lumen of the barrel with a distal end thereof (see fig. 9 as well as fig. 1), wherein the plunger comprises a grip pad 238 attached to the proximal facing surface of the plunger head (top surface of the plunger head that faces toward 238 in fig. 9) and extending at least partly over said proximal facing surface (see fig. 9), wherein the grip pad is made by injection molding (element 238 is fully capable of being formed by this product-by-process limitation, which does not impose any particular structural characteristics beyond those possessed by element 238), wherein the grip pad on the plunger head represents a symbol (concentric circle symbol in fig. 10F), wherein the symbol is represented by void areas 440 surrounded by material (440 are grooves into/surrounded by the material, see par. 0055) or by areas being filled or covered with grip pad injection molding material surrounded by void areas, and wherein the grip pad on the plunger head is made in one piece comprising one injection point only (238 is one piece as illustrated in fig. 9, fully capable of being formed by this product-by-process limitation, which does not impose any particular structural characteristics beyond those possessed by element 238).
Regarding claim 14, as best understood, Runfola discloses a kit comprising parts of a syringe assembly according to claim 12 (“kit” of parts as illustrated in fig. 9 which form a syringe assembly, where thumb pad 238 is provided with the surface embodiment of fig. 10F, as described in par. 0055), wherein the kit comprises: a longitudinal syringe barrel 122 having an inner lumen (interior of 122) for receiving and storing a liquid composition to be administered (see fig. 9), a finger grip configured to be coupled to a proximal end of said barrel (128 in fig. 1, unlabeled in fig. 9), and a plunger (comprising at least 230, 232, and 238) having a plunger rod 230 and a plunger head (proximal-most portion of 230 at the top of fig. 9), wherein the plunger rod is configured to be disposed at least partly within the inner lumen of said barrel with thereof a distal end thereof (see fig. 9 as well as fig. 1), wherein the plunger comprises a grip pad 238 attached to the proximal facing surface of the plunger head (top surface of the plunger head that faces toward 238 in fig. 9) and extending at least partly over said proximal facing surface (see fig. 9), wherein the grip pad is made by injection molding (element 238 is fully capable of being formed by this product-by-process limitation, which does not impose any particular structural characteristics beyond those possessed by element 238), wherein the grip pad on the plunger head represents a symbol (concentric circle symbol in fig. 10F), wherein the symbol is represented by void areas surrounded by material (440 are grooves into/surrounded by the material, see par. 0055) or by areas being filled or covered with grip pad injection molding material surrounded by void areas, and wherein the grip pad on the plunger head is made in one piece comprising one injection point only (238 is one piece as illustrated in fig. 9, fully capable of being formed by this product-by-process limitation, which does not impose any particular structural characteristics beyond those possessed by element 238).
Regarding claim 15, as best understood, Runfola discloses a product comprising a syringe assembly according to claim 12 for cosmetic or therapeutic application (assembly as illustrated in fig. 9, where thumb pad 238 is provided with the surface embodiment of fig. 10F, as described in par. 0055), optionally for replacing or filling a biological tissue or increasing volume of a biological tissue, wherein said product comprises an effective amount of a liquid composition (abstract), optionally an effective amount of a dermal filler composition, which is adapted to be administered to a subject.
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.
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.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Runfola in view of Heinz et al. (US 20040116858).
Regarding claim 13, as best understood, Runfola discloses the syringe assembly according to claim 12, wherein the syringe barrel comprises a connector at a distal end thereof integrally formed with the syringe barrel (distal portion to which cap 168 is secured in fig. 1; par. 0019), wherein the syringe assembly further comprises a tip cap 168, the tip cap covering and sealing the distal end of the syringe barrel (see fig. 1 and par. 0019), except for specifically disclosing the connector is a Luer lock connector, wherein the tip cap is a two-part tip cap comprising a rigid part and an elastomeric part, wherein the maximum outer diameter (Dmax) of the rigid part is less or equal to the outer diameter of the Luer lock connector of the syringe barrel. However, Heinz et al. teaches, in combination with a syringe barrel 1 having a luer lock connector integrally formed therewith (fig. 3; par. 0031), a tip cap (comprising 13 and 15) covering and sealing the distal end of the barrel (see fig. 3) which is two-part (13 and 15) comprising a rigid part 13 and an elastomeric part 15 (see fig. 3; par. 0015), wherein the maximum outer diameter of the rigid part is less or equal to that of the luer lock connector (see fig. 3). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Runfola to utilize a luer lock and corresponding tip cap, such as the one taught by Heinz et al., for the purpose of accommodating needles that utilize luer lock style fittings and to provide sufficient structure to close the syringe prior to use.
Response to Arguments
Applicant’s arguments with respect to the claim(s) as amended have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Morgan (US 20090182284) discloses a similar plunger pad on plunger arrangement to Runfala, see at least par. 0056 and fig. 8.
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 NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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