DETAILED ACTION The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 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 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. Product by Process Limitations Initially, and with respect to claim(s) 11 , 12 and 14 , note that a "product by process" claim is directed to the product per se, no matter how actually made. See In re Thorpe et ah, 227 USPQ 964 (CAFC, 1985) and the related case law cited therein which makes it clear that it is the final product per se which must be determined in a "product by process" claim, and not the patentability of the process, and that, as here, an old or obvious product produced by a new method is not patentable as a product, whether claimed in "product by process" claims or not. As stated in Thorpe, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972); In re Pilkington, 411 F.2d 1345, 1348, 162 USPQ 145, 147 (CCPA 1969); Buono v. Yankee Maid Dress Corp., 77 F.2d 274, 279, 26 USPQ 57, 61 (2d. Cir. 1935). Note that Applicant has burden of proof in such cases as the above case law makes clear. Drawings The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the cap housing and lid (claim 1) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Claim Objections Claim 17 is objected to because of the following informalities: line 1 should be amended to - The medicament delivery device of claim 15, wherein the [[ flanged ]] flange is positioned - . Appropriate correction is required. 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. The following claim limitations Mutually engaging structures (claim 13) has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder Structures (Mutually engaging structures - claim 13) coupled with functional language Structures (Mutually engaging structures - claim 13) s without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier. Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim(s) 13 has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof. A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation: Positive connections (¶0060)(Mutually engaging structures - claim 13) If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action. If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications , 76 FR 7162, 7167 (Feb. 9, 2011). 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 8 , 9, 12 and 113 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 8: The claim limitation “a distal end” in lines 1-2 is unclear. The limitation is unclear because of the earlier recitation of the limitation “a distal end” in line 2 of claim 7 (on which this claim depends) which raises a question of if two “distal ends” are required by the claim 8 or only one. For the sake of examination, the office has assumed that only one distal end is required by the claim. The claim limitation “a needle shield” in line 3 is unclear. The limitation is unclear because of the earlier recitation of the limitation “ a needle shield ” in line 3 of claim 7 (on which this claim depends) which raises a question of if two of “needle shields” are required by the claim 8 or only one. For the sake of examination, the office has assumed that only one needle shield is required by the claim. The claim is unclear because of the limitation “the proximal end” in the final line of the claim. Its unclear which limitation this refers to since two proximal ends have been established in claim 1 (proximal end of the medicament delivery device and the tubular body) (on which this claim depends). For the sake of examination, the office has assumed the claim 8 limitation refers to the proximal end of the tubular body. Regarding claim 9 : The claim recites the limitation " the distal part " in line 3 . There is insufficient antecedent basis for this limitation in the claim. Regarding claim 12 : The claim is unclear because of the term “substantially” in line 2. The term substantially suggests a range on how parallel the opposing edges should be however the specification and claims fails to elaborate on what that range is. For this reason, the claim is unclear and rejected. Claim 13 is rejected due to its dependence on claim 12. 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 1 - 3, 7 , 9 - 12 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2013058697 A1 to Holmqvist . Holmqvist discloses: Regarding claim 1: A cap assembly ( figures 1-4 ) for a medicament delivery device ( column 9, lines 25-30 ) , the cap assembly comprising: a cap ( 14 and 40 ) removably attached to a proximal end ( bottom end as shown in figure 4 ) of the medicament delivery device, the cap ( 14 and 40 ) comprising a cap housing ( 14 ) and a lid ( 40 ) ; and a needle shield remover ( 12 ) comprising a metal tubular body ( see the tubular body as shown in figure 2 and page 6, lines 1-5 indicate the remover body 12 is metal or plastic ) having a longitudinal axis ( center axis through the center of 12 ) and an attachment structure ( 34 ) located at a proximal end ( proximal end as shown in figure 3 ) of the tubular body, where the attachment structure comprises a radially outwardly directed flange ( 34 as shown in figure 3 ) that is securely held inside ( against 38 and 36 ) of the cap ( 14 and 40 ) . Regarding claim 2 : The cap assembly of claim 1, wherein the flange ( 34 ) is sandwiched between an inner surface ( bottom surface of groove 36 inside the lid 40 ) of the lid ( 40 ) and a bearing surface ( top surface of groove 36 that is a part of the lid 40 and is located inside the cap housing 14 ) located inside of the cap housing ( 14 ) . Regarding claim 3 : The cap assembly of claim 1, wherein the flange ( 34 ) connects directly to an inner surface ( abuts 38/36 as shown in figure 3 ) of the lid ( 40 ) when the lid ( 40 ) is attached to a proximal part ( as shown in figure 1 ) of the cap housing ( 14 ) . Regarding claim 7 : The cap assembly of claim 1 further comprising a plurality of gripping members ( 20 and 26 ) located in a distal part of the tubular body ( body of 12 as shown in figure 1 ) that protrude radially inwards relative to the longitudinal axis ( as shown in figure 1 ) , where the gripping members ( 20 and 26 ) are configured to engage a needle shield ( 52 ) such that axial movement of the tubular body directly results in simultaneous axial movement of the needle shield ( as shown in figure 5b the gripping members engage 52 to remove 52 ; page 6, line 30 – page 7, line 9 ) . Regarding claim 9 : The cap assembly of claim 1 further comprising an engaging structure ( see the material A in figure 1 below between the member 20 which is consistent with the 35 USC 112(f) interpretation above ) located in a proximal part ( part C in figure 1 below ) of the tubular body ( tubular body of 12 ) configured to prevent outward radial flexing of the proximal part ( the material A in figure 1 below reduces flexing of the tubular part 12 near the proximal part C ) when the portion of the distal part ( part B in figure 1 below ) flexes radially inward ( flexes due to insertion into lid 40 ) . Figure SEQ Figure \* ARABIC 1 - figure 2 of Holmqvist , annotated by the examiner Regarding claim 10 : The cap assembly of claim 1, wherein a distal part ( part surrounding 24 of the tubular body 12 ) of the tubular body ( 12 ) comprises an inner diameter ( the inner diameter formed by the plurality of tips 30 of 24 ) , that in a relaxed state ( state in which no needle shield is within the points 30 ) , is smaller than an outer diameter of a needle shield ( 52 ) that is to be accommodated by the tubular body ( as shown in figure 5a, the diameter between 30 is smaller than the needle shield 52 ) . Regarding claim 1 1 : The cap assembly of claim 1, wherein the tubular body ( 12 ) is formed from a single rolled metal sheet ( this limitation has been interpreted as a product by process limitation since the reference teaches the structural requirements of the claim including that the structure is tubular and made of metal, see the product by process arguments above ) . Regarding claim 1 2 : The cap assembly of claim 1, wherein the tubular body further comprises substantially parallel opposing edges (see the edges D and F in figure 1 above) of a single rolled metal sheet ( this limitation has been interpreted as a product by process limitation since the reference teaches the structural requirements of the claim including that the structure is tubular and made of metal, see the product by process arguments above ) . Regarding claim 1 5 : A medicament delivery device ( figures 1-4 ) comprising: a housing ( 56 as shown in figure 4 ) comprising a needle ( 50 ) mounted to a medicament container ( column 9, lines 25-30 ) , where the needle is covered by a needle shield ( 58 ) ; and a cap assembly ( 14/40/12 ) removably attached to a proximal end ( bottom end as shown in figure 4 ) of the medicament delivery device, where the cap assembly comprises: a cap ( 14 and 40 ) having a cap housing ( 14 ) and a lid ( 40 ) ; and a needle shield remover ( 12 ) comprising a metal tubular body ( see the tubular body as shown in figure 2 and page 6, lines 1-5 indicate the remover body 12 is metal or plastic ) having a longitudinal axis ( center axis through the center of 12 ) and an attachment structure ( 34 ) located at a proximal end ( proximal end as shown in figure 3 ) of the tubular body, where the attachment structure ( 34 ) comprises a radially outwardly directed flange ( 34 as shown in figure 3 ) that is securely held inside ( against 38 and 36 ) of the cap ( 14 and 40 ) . 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. Claim(s) 4-6 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2013058697 A1 to Holmqvist as applied to claim 1 above, and further in view of WO 2014091153 A1 to Fournier et al. (Fournier) . Regarding claim 4 : Holmqvist fails to disclose: The cap assembly of claim 1, wherein the flange comprises a plurality of tongues. Fournier teaches: A cap assembly that includes a cap ( 25 ) and an external cap ( 30 ). Further, the connection between the cap and the external cap is a plurality of tongues ( 36 ) with cut outs between then (see figure 4 ) that extend radially to fix the cap and the external cap to each other. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Holmqvist to replace the flange in Holmqvist with a plurality of radially extending tongues (with cut outs between them) as taught by Fournier . This is a simple substitution of one known element (flange of Holmqvist ) for another (radially extending tongues as taught by Fournier ) to obtain predictable results (to secure the needle shield to the lid). Regarding claim 5 : All limitations of the claim are taught by the 35 USC 103 rejection of claim 4 by Holmqvist and Fournier : The cap assembly of claim 1, wherein the flange comprises at least two tongues ( see the plurality of tongues of Fournier incorporated into Holmqvist ) and a cut-out adjacent and separating the at least two tongues ( see the cutouts between the tongues as taught by Fournier incorporated into Holmqvist ) . Regarding claim 6 : All limitations of the claim are taught by the 35 USC 103 rejection of claim 4 by Holmqvist and Fournier : The cap assembly of claim 1, wherein the flange comprises tongues ( see the plurality of tongues of Fournier incorporated into Holmqvist ) that are formed by cut-outs ( see the cutouts between the tongues as taught by Fournier incorporated into Holmqvist ) in a terminal end ( at the end of the needle shield remover 12 of Holmqvist ) of the proximal end of the tubular body ( at the end portion of the tubular body 12 of Holmqvist ) . Regarding claim 14 : All limitations of the claim are taught by the 35 USC 103 rejection of claim 4 by Holmqvist and Fournier : The cap assembly according to claim 1, wherein the flange comprises a plurality of tongues ( see the plurality of tongues of Fournier incorporated into Holmqvist ) that are formed by punching cut-outs ( see the cutouts between the tongues as taught by Fournier incorporated into Holmqvist ) along an edge ( top portion of the tubular body 12 of Holmqvist ) of a single metal sheet and then folding the tongues before shaping the metal sheet into the tubular body ( interpreted as a product by process limitation and since the combination teaches the structure it is interpreted to read on this claim language ) such the tongues are generally perpendicular to the longitudinal axis ( see how the plurality of tongues of Fournier are perpendicular to the longitudinal axis and would be incorporated accordingly into Holmqvist ) . Allowable Subject Matter Claim s 8 and 13 would be allowable if rewritten 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 and to include all of the limitations of the base claim and any intervening claims. Claim s 16-18 are 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. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT WESLEY HARRIS whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-3665 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M to F, 9am-5pm . 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 on (571) 270- 5246 . 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. /WESLEY G HARRIS/ Examiner, Art Unit 3783