NON-FINAL REJECTION
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 (claims 1-27) in the reply filed on 2/17/2026 is acknowledged.
Accordingly, claim 28 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a), (b), and (d):
(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.
(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.
(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.
Claims 1-27 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 recites “[a] surgical imaging device for spectral imaging”. The device includes, among other elements, a shaft, an imaging channel, and an image sensor. Claim 26 recites “[a] medical imaging scope including he imaging device set forth in claim 1.” Further, claim 27 recites that “the medical imaging scope is one of an endoscope and an exoscope.”
The doctrine of claim differentiation it is presumes that additionally cited limitations of dependent claims are not required in the independent claim that said dependent claims depend from. Applied in this case, it is initially presumed that the additional limitations of (1) the medical imaging scope and (2) that the medical imaging scope is either an endoscope or an exoscope are not required to meet claim 1. In other words, claim 1 can be presumed to also cover surgical imaging devices that are not considered medical imaging scopes, let alone endoscopes or exoscopes. However, it is not clear to the ordinarily skilled artisan what surgical imaging devices comprising a shaft, an imaging channel, and an imaging sensor, among other recited elements of the claim, wouldn’t also read on a medical imaging scope.
This also gives rise to the question of what the definitions of an endoscope and an exoscope really are. Assuming, that they are both medical imaging scopes and in the broadest sense the only difference is whether they are used inside or outside the body, it would seem that all medical imaging scopes would either be an endoscope or an exoscope (or even both), since inside and outside the body appears to be all-inclusive. (Otherwise, what precisely are the definitions of “endoscope” and “exoscope”?)
Combining the two discussions, it would therefore not be clear to the ordinarily skilled artisan what surgical imaging devices comprising a shaft, an imaging channel, and an imaging sensor, among other recited elements of the claim, wouldn’t also read on either an endoscope or an exoscope.
However, the fact that claim 1 originally read as “[a]n endoscopic and/or exoscopic imaging device” and then was amended to recite “[a] surgical imaging device” in combination with the amendments to dependent claims 26 and 27 seem to indicate that applicant meant for claims 26 and 27 to be further limiting. In other words, Applicant seems to have intended for claim 1 to be broad enough to capture embodiments that are neither endoscopes nor exoscopes, or even embodiments that are non-“medical imaging scopes”; however, it is not clear to the ordinarily skilled artisan what such embodiments would even be.
It is noted that the Applicant does not appear to have disclosed any example embodiment of the claimed invention that is neither an endoscope nor an exoscope, let alone an example embodiment that is not a medical imaging scope; i.e., the only embodiments that Applicant appears to have disclosed are the endosope and the exoscope embodiments.
Therefore, the scope of claim 1 (at least, the non-“medical imaging scope” and non-“endoscope/exoscope” portions of the scope claim 1) is not clear to the ordinarily skilled artisan.
Claims 1-26 are rejected under 35 U.S.C. 112(a) 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 at the time the application was filed, had possession of the claimed invention.
It is initially noted that claims 1-27 are rejected above for being indefinite. Assuming the doctrine of claim differentiation applies (however it is unclear if it does or otherwise if there is a §112(d) issue), Applicant does not provide support for the broadened scope of claim which was amended to no longer recite an “endoscopic and/or exoscopic imaging device” but now recite more broadly a “surgical imaging device”.
MPEP 2163.05 recites in part:
I. BROADENING CLAIM
A. Omission of a Limitation
Under certain circumstances, omission of a limitation can raise an issue regarding whether the inventor had possession of a broader, more generic invention. See, e.g., Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473, 45 USPQ2d 1498 (Fed. Cir. 1998) (claims to a sectional sofa comprising, inter alia, a console and a control means were held invalid for failing to satisfy the written description requirement where the claims were broadened by removing the location of the control means.); Johnson Worldwide Assoc. v. Zebco Corp., 175 F.3d 985, 993, 50 USPQ2d 1607, 1613 (Fed. Cir. 1999) (In Gentry Gallery, the "court’s determination that the patent disclosure did not support a broad meaning for the disputed claim terms was premised on clear statements in the written description that described the location of a claim element--the ‘control means’--as ‘the only possible location’ and that variations were ‘outside the stated purpose of the invention.’ Gentry Gallery, 134 F.3d at 1479, 45 USPQ2d at 1503. Gentry Gallery, then, considers the situation where the patent’s disclosure makes crystal clear that a particular (i.e., narrow) understanding of a claim term is an ‘essential element of [the inventor’s] invention.’"); Tronzo v. Biomet, 156 F.3d at 1158-59, 47 USPQ2d at 1833 (Fed. Cir. 1998) (claims to generic cup shape were not entitled to filing date of parent application which disclosed "conical cup" in view of the disclosure of the parent application stating the advantages and importance of the conical shape.); In re Wilder, 736 F.2d 1516, 222 USPQ 369 (Fed. Cir. 1984) (reissue claim omitting "in synchronism" limitation with respect to scanning means and indexing means was not supported by the original patent’s disclosure in such a way as to indicate possession, as of the original filing date, of that generic invention.).
A claim that omits an element which applicant describes as an essential or critical feature of the invention originally disclosed does not comply with the written description requirement. See Gentry Gallery, 134 F.3d at 1480, 45 USPQ2d at 1503; In re Sus, 306 F.2d 494, 504, 134 USPQ 301, 309 (CCPA 1962) ("[O]ne skilled in this art would not be taught by the written description of the invention in the specification that any ‘aryl or substituted aryl radical’ would be suitable for the purposes of the invention but rather that only certain aryl radicals and certain specifically substituted aryl radicals [i.e., aryl azides] would be suitable for such purposes.") (emphasis in original). Compare In re Peters, 723 F.2d 891, 221 USPQ 952 (Fed. Cir. 1983) (In a reissue application, a claim to a display device was broadened by removing the limitations directed to the specific tapered shape of the tips without violating the written description requirement. The shape limitation was considered to be unnecessary since the specification, as filed, did not describe the tapered shape as essential or critical to the operation or patentability of the claim.). A claim which omits matter disclosed to be essential to the invention as described in the specification or in other statements of record may also be subject to rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as not enabling, or under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976); In re Venezia, 530 F.2d 956, 189 USPQ 149 (CCPA 1976); and In re Collier, 397 F.2d 1003, 158 USPQ 266 (CCPA 1968). See also MPEP § 2172.01.
B. Addition of Generic Claim
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species. A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus."). The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]." See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615. "A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) (Claims directed to PTFE dental floss with a friction-enhancing coating were not supported by a disclosure of a microcrystalline wax coating where there was no evidence in the disclosure or anywhere else in the record showing applicant conveyed that any other coating was suitable for a PTFE dental floss.) On the other hand, there may be situations where one species adequately supports a genus. See, e.g., In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 323, 326-27 (CCPA 1981) (disclosure of a single method of adheringly applying one layer to another was sufficient to support a generic claim to "adheringly applying" because one skilled in the art reading the specification would understand that it is unimportant how the layers are adhered, so long as they are adhered); In re Herschler, 591 F.2d 693, 697, 200 USPQ 711, 714 (CCPA 1979) (disclosure of corticosteriod in DMSO sufficient to support claims drawn to a method of using a mixture of a "physiologically active steroid" and DMSO because "use of known chemical compounds in a manner auxiliary to the invention must have a corresponding written description only so specific as to lead one having ordinary skill in the art to that class of compounds. Occasionally, a functional recitation of those known compounds in the specification may be sufficient as that description."); In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 285 (CCPA 1973) (the phrase "air or other gas which is inert to the liquid" was sufficient to support a claim to "inert fluid media" because the description of the properties and functions of the air or other gas segmentizing medium would suggest to a person skilled in the art that appellant’s invention includes the use of "inert fluid" broadly.). However, in Tronzo v. Biomet, 156 F.3d 1154, 1159, 47 USPQ2d 1829, 1833 (Fed. Cir. 1998), the disclosure of a species in the parent application did not suffice to provide written description support for the genus in the child application where the specification taught against other species. See also In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989) (generic and subgeneric claims in the U.S. application were not entitled to the benefit of foreign priority where the foreign application disclosed only two of the species encompassed by the broad generic claim and the subgeneric Markush claim that encompassed 21 compounds).
In this case, Applicant does not appear to provide support for the broader “surgical imaging device”. The only embodiments ever contemplated by the Applicant appears to be the endoscope and the exoscope. The Applicant does not appear to provide any examples of non-“endoscope and/or exoscope” embodiments, let alone non-“medical imaging scope” embodiments.
Claims 26 and 27 are rejected under 35 U.S.C. 112(d) 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.
It is initially noted that claims 1-27 are rejected above for being indefinite. Assuming the doctrine of claim differentiation (as discussed above regarding the §112(b) rejection) does not apply here, then claims 26 and 27 do not appear to further limit claim 1 because the surgical imaging device of claim 1 would also be considered a medical imaging scope and either an endoscope and/or an exoscope.
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.
Examiner’s Remarks Regarding Rejection Based On Prior Art
MPEP 2173.06 recites in part:
II. PRIOR ART REJECTION OF CLAIM REJECTED AS INDEFINITE
All words in a claim must be considered in judging the patentability of a claim against the prior art. In re Wilson, 424 F.2d 1382, 165 USPQ 494 (CCPA 1970). The fact that terms may be indefinite does not make the claim obvious over the prior art. When the terms of a claim are considered to be indefinite, at least two approaches to the examination of an indefinite claim relative to the prior art are possible.
First, where the degree of uncertainty is not great, and where the claim is subject to more than one interpretation and at least one interpretation would render the claim unpatentable over the prior art, an appropriate course of action would be for the examiner to enter two rejections: (A) a rejection based on indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph; and (B) a rejection over the prior art based on the interpretation of the claims which renders the prior art applicable. See, e.g., Ex parte Ionescu, 222 USPQ 537 (Bd. App. 1984). When making a rejection over prior art in these circumstances, it is important for the examiner to point out how the claim is being interpreted. Second, where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 U.S.C. 103 should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims.
The first approach is recommended from an examination standpoint because it avoids piecemeal examination in the event that the examiner’s 35 U.S.C. 112, second paragraph rejection is not affirmed, and may give applicant a better appreciation for relevant prior art if the claims are redrafted to avoid the 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph rejection.
In this case, there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of the claims as discussed above in the §112(b) rejection. The scope of claim 1 (particularly the non-“medical imaging scope” and non-“endoscope/exoscope” portions of the scope claim 1) is not clear to the ordinarily skilled artisan as discussed above. From another point of view, it is unclear what precisely the definitions of a “medical imaging scope”, an “endoscope”, and an “exoscope” are as they relate to the issues of the claim differentiation doctrine discussed above. For example, where is the precise line that differentiates between a “medical imaging scope” embodiment of the invention and a non-“medical imaging scope” embodiment of the invention, etc.? It would not be proper to reject such a claim on the basis of prior art (e.g., 35 U.S.C. §103) because such a rejection should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims, In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962).
Otherwise, it is noted that DE 10 2014 115738 A1 and US 2010/0079587 A1 are relevant to the invention as disclosed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLIN T. SAKAMOTO whose telephone number is (571)272-4958. The examiner can normally be reached Monday - Friday, ~9AM-5PM Pacific.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEITH M. RAYMOND can be reached at (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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COLIN T. SAKAMOTO
Primary Examiner
Art Unit 3798
/COLIN T. SAKAMOTO/Primary Examiner, Art Unit 3798
31 May 2026
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