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 .
DETAILED ACTION
Status of the Claims
1. Claims 1-47 are the original claims filed 9/8/2022. In the Preliminary Amendment of 9/8/2022, claims 2, 4-5, 7, 10, 13, 16, 19, 22-23, 25-26, 28, 33-34, 37, 39-40, 42 and 45-47 are amended and claims 3, 6, 8-9, 11-12, 14-15, 17-18, 20-21, 24, 27, 29-32, 35-36, and 43-44 are cancelled. In the Response of 12/2/2025, Claims 1, 5, 22, 26, 28, 33, 37, 38, 40, 42 and 45-47 are amended, and Claims 2, 4, 7, 10, 13, 16 and 19 are canceled.
Claims 1, 5, 22-23, 25-26, 28, 33-34, 37-42, and 45-47 are pending.
The amendments of the claims raise new grounds for objection and rejection. The Office Action is final.
Priority
2. USAN 17/910,327, filed 09/08/2022, is a National Stage entry of PCT/EP2021/ 056349, International Filing Date: 03/12/2021, claims foreign priority to EP 20163019.1, filed 03/13/2020.
Information Disclosure Statement
3. As of 1/8/2026, a total of four (4) IDS are filed: 9/8/2022; 12/12/2022; 3/3/2025; and 12/2/2025. The corresponding initialed and dated 1449 form is considered and of record. The submissions are in compliance with the provisions of 37 CFR 1.97.
Withdrawal of Objections
Drawings
4. The objection to the drawing sheet for Figure 16 because of the improper use of the term “Retrogenix” is withdrawn. The term is deleted from the figure.
Specification
5. The objection to the abstract of the disclosure because it contains legal phraseology (i.e., “said”) and indefinite language (i.e., “such as”) is withdrawn in view of the deletion of the terms in the replacement abstract.
6. The objection to the disclosure because of informalities is withdrawn.
a) The replacement specification rectifies the improper use of the term, i.e., ATCC, UniProt, DART, BiTE, Alexa, HiTrap, Retrogenix, Lightcycler, BiaCore, Dynabeads, GlutaMax, Calphos, Ficoll, ExCelligence, Ready-SET-Go!, FlowJo, SpectraMax, FACSCanto, Superdex, Sypro, Tween, PHENIX, HIS-select, which is a trade name or a mark used in commerce.
b) The replacement specification rectifies the improper citation of the sequences “(Gly4Ser)3”, “DWTSLNI”, “DDRWSLNI”, and “(VH-3x(GGGGS)-VL)” that are > 4 amino acids in length that pursuant to 37 CDR1.821-1.835 are now identified by a sequence identifier.
c) The replacement specification rectifies the improper citation of the nucleic acid sequences that are > 10 nucleotides in length that pursuant to 37 CDR1.821-1.825 are now identified by a sequence identifier.
d) The replacement specification rectifies the bold and indecipherable double-bold text.
e) The replacement specification replaces the phrase “a g/d T cell” with “a γ/δ T cell”.
Withdrawal of Rejections
Claim Rejections - 35 USC § 101
7. The rejection of Claims 46-47 under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter is withdrawn. The Swiss-type use claims are replaced with method claims drawn to treatment and susceptibility testing, respectively.
Objections Withdrawn-in-Part/ Maintained-in-Part
Claim Objections
8. The objection to Claims 1-2, 4-5, 7, 10, 13, 16, 19, 22-23, 25-26, 28, 33-34, 37-42, and 45-47 because of informalities is:
moot for the canceled claims 2, 4, 7, 10, 13, 16 and 19.
withdrawn for the following objections
a) Claim 1 is amended to introduce the full name of the target protein as “human receptor tyrosine kinase-like orphan receptor 2 (ROR2),”.
b) Claim 1 is amended to eliminate the phrase “derivative thereof capable of binding to human ROR2,” to avoid redundancy.
c) Claims 1-2, 4-5, 7, 10, 13, 16, 19, 22-23, 25-26, 28, 33-34, 37-42, and 45-47 are amened to delete the phrase “capable of binding”.
d) Claim 28 is amended to eliminate redundancy for the phrase “
e) Claims 37-47 are amended in claim 37 to delete references to different claims drawn to different features (MPEP 608.01(n)).
f) Claims 22 and 33 are amended to recite “or derivative thereof”.
g) Claims 42 and 45 are amended to recite “The pharmaceutical composition
Maintained for the following objections:
h) Amend claim 38 to delete duplicate subject matter for the term “an natural killer cell” and “a natural killer cell.” Newly amended claim 38 recites:
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Appropriate correction is required.
The response is incomplete. The objection is maintained.
Rejections Withdrawn-in-Part/ Maintained-in-Part
Claim Rejections - 35 USC § 112(b)
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.
9. The rejection of Claims
moot for canceled claims 43-44.
withdrawn for the following rejections.
a) Generic Claims 37, 40 and 47 are amended to depend from claim 1, and generic claim 46 is amended to depend from claim 47.
b) Claims 37-47 are amended to delete the limitation "a nucleic acid according to any one of claims 33-36 which encodes the CAR of claim 28 (b)" in claims 37, 40, 46 and 47.
maintained for the following rejections.
c) Claim 38 recites a “g/d T cell.” The specification includes the term without explanation. If what is intended is a γ/δ T cell, then the claim requires correction. If what Applicants intend is such a cell, then potential grounds for enablement may arise in a subsequent Office Action.
The response is incomplete. The rejection is maintained.
Claim Rejections - 35 USC § 112(a)
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Written Description
10. The rejection of Claims 1-2, 4-5, 7, 10, 13, 16, 19, 22-23, 25-26, 28, 33-34, 37-42, and 45 and 46-47 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is:
moot for the canceled claims 2, 4, 7, 10, 13, 16 and 19.
Withdrawn-in-part for claims 1, 5, 22-23, 25-26, 28, 33-34, 37-42, and 45-47 drawn to the anti-ROR2 antibodies comprising the VLCDR1-3 of SEQ ID NOS: 42-42-43 paired with the VHCDR1-3 of SEQ ID NOS: 44-45-26; 44-45-27; 44-45-28; 44-45-29; 44-45-30; 44-45-31; 44-45-32; 44-45-33; 44-45-34; 44-45-35; 44-45-37; or 44-45-38.
Maintained-in-part for claims 1, 5, 22-23, 25-26, 28, 33-34, 37-42, and 45-47 drawn to the derivatives of the anti-ROR2 antibodies comprising the VLCDR1-3 of SEQ ID NOS: 42-42-43 paired with the VHCDR1-3 of SEQ ID NOS: 44-45-26; 44-45-27; 44-45-28; 44-45-29; 44-45-30; 44-45-31; 44-45-32; 44-45-33; 44-45-34; 44-45-35; 44-45-37; or 44-45-38.
The original grounds for the rejection are maintained and excerpted herein below for brevity from the Office Action of 6/4/2025.
Claim construction/ interpretation
““derivative”: the specification is unequivocal in its teaching the breadth and scope of the range of structures falling within the meaning of the term, namely, e.g., a CAR construct or a single domain antibody.
[0011] The present invention inter alia relates to affinity matured and humanized binding domains of the known anti-ROR2 antibody XBR2-401 and the uses thereof for the construction of bi-specific antibodies (bi-mAbs), and antibody derivatives such as CARs and CAR engineered T cells.
[0172] An antibody derivative or derivative of an antibody capable of binding to ROR2 as used herein comprises a portion of an antibody that retains the capability of the antibody to specifically bind to the ROR2 antigen. This capability can, for instance, be determined by determining the capability of the antigen-binding portion to compete with the antibody for specific binding to the antigen by methods known in the art. Without particular limitation, the antibody derivative can be produced by any suitable method known in the art, including recombinant DNA methods and preparation by chemical or enzymatic fragmentation of antibodies. Antibody derivatives may be fragments may be Fab fragments, F(ab′) fragments, F(ab′)2 fragments, single chain antibodies (scFv), single-domain antibodies, diabodies or any other portion(s) of the antibody that retain the capability of the antibody to specifically bind to the antigen. Antibody derivatives of the invention may also be chimeric antigen receptors (CARs).
The interpretation encompasses a genus of anti-hROR2 antibody variants and derivatives beyond those taught in the specification. Because applicant seeks patent protection for all such anti-hROR2 antibodies, this genus must be adequately described. A description adequate to satisfy 35 U.S.C. § 112(a) must clearly allow persons of ordinary skill in the art to recognize that the inventor invented what is claimed (Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (citation omitted, alteration in original). The purpose of the written description requirement is to “ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent’s specification” (In re Katz Interactive Call Processing Patent Litig. 639 F.3d 1303, 1319 (Fed. Cir 2011).”
It is asserted that neither the specification nor the state of art at the time of filing disclosed structural features common to the members of the genus for reliably assigning different antibody structures derived from an anti-ROR2 antibody which would support the premise that the inventors possessed the full scope of the claimed invention for derivatives of any kind.
The response is incomplete. The rejection is maintained.
Rejections Maintained
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
11. The provisional rejection of Claims 1, 5, 22-23, 25-26, 28, 33-34, 37-42, and 45-47 on the ground of nonstatutory double patenting as being unpatentable over claim 55 IV.) of copending Application No. 17/619,569 (reference application US 20220306719) is moot for the canceled claims 2, 4, 7, 10, 13, 16 and 1, and maintained for the pending claims. Applicants request that the provisional rejection be held in abeyance is granted.
The rejection is maintained.
New Grounds for Objection
Claim Objections
12. Claims 22 and 47 are objected to because of the following informalities:
a) Amend claim 22 to recite:
22. The antibody or derivative thereof of claim 1, wherein said antibody or derivative thereof [is] binds to human ROR2 with higher affinity than a corresponding antibody or derivative thereof comprising a light chain variable domain having the amino acid sequence of SEQ ID NO: 2 and a heavy chain variable domain having the amino acid sequence of SEQ ID NO: 1, as determined by surface plasmon resonance measurements.
b) Claim 47 is unclear and imprecise for the phrase “comprising contacting a sample the cancer.”
Appropriate correction is required.
New Grounds for Rejection
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.
13. Claims 28, 37-42, and 45-46 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.
a) Claim 28 is indefinite for failing to include transitional language. The claimed derivative of the “wherein” clause is the broad term and is not linked logically, to the descriptions that follow. MPEP 2173.
b) A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 37 (and claims 38-39) recites the broad recitation “a CAR comprising the antibody or derivative thereof, or a nucleic acid encoding the antibody or derivative thereof or CAR”, and the claim also recites “a CAR comprising the antibody or derivative thereof of claim 1”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
c) Claims 40-42 and 45-46 are indefinite for failing to include material description of the invention between the comma and the period for the phrase “a cell comprising the nucleic acid, .” in claim 40.
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.
14. Claim 47 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.
Claim 47 is drawn to a method for determining the susceptibility of a cancer to therapy using an anti-ROR+ recombinant immune cell, comprising contacting a sample the cancer with the antibody or derivative thereof of claim 1 and identifying the cancer as a ROR+ cancer.
Claim 1 is drawn to an antibody or derivative thereof that binds to human receptor tyrosine kinase-like orphan receptor 2 (ROR2).
Claim 47 is broadening in scope for the ROR antigen to which the antibody/ derivative thereof of claim 1 binds.
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.
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Written Description/ New Matter
15. Claim 47 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 47 is drawn to a method for determining the susceptibility of a cancer to therapy using an anti-ROR+ recombinant immune cell, comprising contacting a sample the cancer with the antibody or derivative thereof of claim 1 and identifying the cancer as a ROR+ cancer.
Claim 1 is drawn to an antibody or derivative thereof that binds to human receptor tyrosine kinase-like orphan receptor 2 (ROR2).
A search of the specification for each of the limitations does not identify literal support for these limitations. The specification teaches throughout ROR2-expressing cancers and to which the antibodies of claim 1 bind. The specification does not teach or suggest any “ROR+ cancer” or examples thereof. The specification does not teach or suggest other ROR antigens than ROR2. The claimed method is not supported by the specification. (MPEP 706.03(m) states in part "New matter includes not only the addition of wholly unsupported subject matter, but may also include adding specific percentages or compounds after a broader original disclosure, or even the omission of a step from a method. See MPEP § 608.04 to § 608.04(c). See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) and MPEP § 2163.05 for guidance in determining whether the addition of specific percentages or compounds after a broader original disclosure constitutes new matter.”)
Enablement
16. Claim 46 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Factors to be considered in determining whether undue experimentation is required, are summarized in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). They include the nature of the invention, the state of the prior art, the relative skill of those in the art, the amount of direction or guidance disclosed in the specification, the presence or absence of working examples, the predictability of the art, the breadth of the claims, the quantity of experimentation which would be required in order to practice the invention as claimed.
Claim construction
Claim 46 recites a method of treatment comprising administering the pharmaceutical composition of claim 40 to a cancer patient having any cancer irrespective of the cancer being ROR2+. The pharmaceutical composition of claim 40 comprises the antibody or derivative thereof of claim 1, a CAR comprising the antibody or derivative thereof, a cell comprising the CAR, a nucleic acid encoding the antibody or derivative thereof or the CAR, and/or a cell comprising the nucleic acid.
That claim 40 depends on claim 1 thereby encompasses both the antibody VH/VL CDR1-3 much any derivatives thereof and that are required to be therapeutic against any cancer in any patient having the cancer.
A nucleic acid encoding the antibody or derivative thereof or the CAR reads on gene therapy.
A cell comprising the nucleic acid reads on gene therapy.
“treatment”: the specification explains that treatment refers to therapeutic outcomes:
[0174] Terms such as “treatment of cancer” or “treating cancer” or “cancer therapy” or “cancer immunotherapy” according to the present invention refer to a therapeutic treatment. An assessment of whether or not a therapeutic treatment works can, for instance, be made by assessing whether the treatment inhibits cancer growth in the treated patient or patients. Preferably, the inhibition is statistically significant as assessed by appropriate statistical tests which are known in the art. Inhibition of cancer growth may be assessed by comparing cancer growth in a group of patients treated in accordance with the present invention to a control group of untreated patients, or by comparing a group of patients that receive a standard cancer treatment of the art plus a treatment according to the invention with a control group of patients that only receive a standard cancer treatment of the art. Such studies for assessing the inhibition of cancer growth are designed in accordance with accepted standards for clinical studies, e.g. double-blinded, randomized studies with sufficient statistical power. The term “treating cancer” includes an inhibition of cancer growth where the cancer growth is inhibited partially (i.e. where the cancer growth in the patient is delayed compared to the control group of patients), an inhibition where the cancer growth is inhibited completely (i.e. where the cancer growth in the patient is stopped), and an inhibition where cancer growth is reversed (i.e. the cancer shrinks). An assessment of whether or not a therapeutic treatment works can be made based on known clinical indicators of cancer progression. In the context of hematological cancers which do not form solid tumors, cancer growth may be assessed by known methods such as methods based on a counting of the cancer cells.
Disclosure in the Specification
[0227] Clones hX3.12.5 and hX3.12.6 also bound to breast cancer cell line T47D (ROR2+, ROR1−) and renal cell adenocarcinoma cell line 786-O (ROR2+, ROR1+) but not to breast cancer cell line MDA231 (ROR2−, ROR1+) (FIG. 13A).
The specification does not support the genus of any cancers in any patient being treated with the one or all of the reagents of claim 40. The specification does not support treatment of any cancer using a nucleic acid encoding the antibody or derivative thereof or the CAR that reads on gene therapy and/or any cell comprising the nucleic acid reads on gene therapy.
The scope of the claims must bear a reasonable correlation with the scope of enablement. See In re Fisher, 166 USPQ 19, 24 (CCPA 1970). "[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.'" Genentech, Inc. v. Novo Nordisk, A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)).
The Patent Act requires that patent applicant describes the invention in explicit terms to enable any person skilled in the art to make and use the invention. 35 U.S.C. 112. Applicants seek the reagents of claim 40 much less the derivatives of the antibodies encompassed by any one of those reagents for use in a generic method of treating just any cancer in any cancer patient. The enablement requirement is a crucial aspect of the patent “bargain”: an inventor is granted limited protection from competition in exchange for publicly disclosing their new technology. See the decision in Morse, Incandescent Lamp, and Holland Furniture, establishing the requirement that if a patent claims an entire class or genus of processes, machines, or compositions of matter, the specification must enable a person skilled in the field to make and use the entire class. If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class. In other words, the specification must enable the full scope of the invention as defined by its claims. The more one claims, the more one must enable. See §112(a); see also Continental Paper Bag Co. v. Eastern Paper Bag Co., 210 U. S. 405 (1908) (“[T]he claims measure the invention.”)
Conclusion
17. No claims are allowed.
18. 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.
19. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM.
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LYNN ANNE BRISTOL
Primary Examiner
Art Unit 1643
/LYNN A BRISTOL/Primary Examiner, Art Unit 1643